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The Indian Pharmaceutical companies are growing unprecedentedly and showing their significant presence in the global market. India is the largest provider of generic drugs globally. Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of generic demand in the US, and 25% of all medicine in the UK. The country also has a large pool of scientists and engineers with the potential to steer the industry ahead to greater heights. Presently, over 80% of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms. 

According to the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. As a result, India’s domestic pharmaceutical market is estimated at US$ 42 billion in 2021 and likely to reach US$ 65 billion by 2024 and further expand to reach US$ 120-130 billion by 2030.

With a strong network of 3000 drug companies and about 10,500 manufacturing units, the Indian pharmaceutical industry production ranks 3rd worldwide by volume and 14th by value. Out of these units, the following are the approvals received from regulatory authorities until now.

• More than 2,000 units are World Health Organization (WHO) good manufacturing practice (GMP) approved
• 253 are European Directorate of Quality Medicines (EDQM)-approved plants
• 1,105 have Europe’s Certificate of Suitability (CEPs)
• More than 950 match therapeutic goods administration (TGA) guidelines
• 584 sites are approved by the US Food and Drug Administration (US FDA)

More than 20000 Pharma companies are manufacturing their products in different states. Major pharmaceutical hubs in India are (clockwise from the northwest): Vadodara, Ahmedabad, Ankleshwar (Gujarat), Vapi (Gujarat), Baddi (Himachal Pradesh), Sikkim, Kolkata, Visakhapatnam, Hyderabad, Bangalore, Chennai, Mumbai, Pune, and Aurangabad. Let us go through the Top 10 Indian Pharmaceutical Companies as per market capitalization as of August 2021.

1. Sun Pharmaceutical Industries: Rs 182,469 crores

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company globally, supported by more than 40 manufacturing facilities.

2. Divi’s Laboratories: Rs 128,794 crores

Divi is the leading manufacturer of APIs, Intermediates, and Registered starting materials, offering high-quality products with the highest level of compliance and integrity to over 95 countries.

3. Dr. Reddy’s Laboratories: Rs 75,113 crores

Dr. Reddy’s Laboratories was established in 1984. They offer more than 200 high-quality generic versions of expensive innovator medicines in over 80 countries worldwide.

4. Cipla: Rs 73,042 crores

Cipla has a presence in 80 plus countries providing over 1,500 products across various therapeutic categories in 50 plus dosage forms. 

5. Gland Pharma: Rs 64,163 crores

Gland Pharma was established in Hyderabad in 1978. They have a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

6. Cadila Healthcare: Rs 55,727 crores

Cadila Healthcare, also known as Zydus Cadila, an Indian Pharmaceutical company, is headquartered in Ahmedabad. From a humble turnover of Rs. 250 crores in 1995 the group witnessed significant financial growth and registered a turnover of over Rs. 15,000 crores in FY-21.

7. Torrent Pharmaceuticals: Rs 51,927 crores

Torrent Pharma is one of the leading pharma companies in the Country. The Company is ranked amongst the leaders in the therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastrointestinal (GI), and women healthcare (WHC). 

8. Alkem Laboratories: Rs 45,759 crores

Alkem Laboratories is one of India’s largest generic pharmaceutical companies and has a foothold in over 50 countries. It has 20 manufacturing facilities at multiple India and the United States of America locations. 

9. Lupin: Rs 41,917 crores

Lupin employs 20,000+ members in 11 countries across six continents, enabling safe and reliable delivery of medicines to their patients across 100+ countries.

10. Aurbindo Pharma: Rs 39,328 crores

Aurobindo Pharma features among India’s top 2 pharmaceutical companies in consolidated revenues. Aurobindo exports to over 150 countries across the globe, with around 90% of revenues derived from international operations.

For more such insights, stay tuned to our website https://newedgeoverseas.com/.

The pharmaceutical industry can be portrayed as a complex system of processes, operations, and organizations to discover, develop, and manufacture drugs. Pharmaceutical companies operating in this industry are responsible for:

• Research and development (R&D) activities
• Development and manufacturing of active pharmaceutical ingredients (APIs)
• Drugs manufacturing (FDFs)

Regulatory authorities EMA, WHO, and FDA, have published the guidance on the manufacturing of drug products. In addition, GDUFA (The Generic Drug User Fee Act) defines an FDF as:

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;
(B) a drug product in a form in which reconstitution is necessary before administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient (as per statute) with another component of drug product for purposes of production of drug product described in subparagraph (A) or (B).

In simple terms, FDF stands for Finished Dosage Form, and it refers to the actual finalized drug product that is meant for consumption. Finished Dosage Form(s) means concerning a Product, the finished package form of such Product ready for sale to wholesalers, hospitals, or end-users. A specific dosage form may be a requirement for certain drugs due to various factors like chemical stability or pharmacokinetics. The reasons for converting drug to dosage forms are mentioned as below:

1. Accurate dose
2. Protection, e.g., coated tablets, sealed ampoules
3. Protection from gastric juice
4. Masking taste and odor (to make palatable)
5. Placement of drugs within body tissues
6. Sustained-release medication
7. Controlled release medication
8. Optimal drug action
9. Insertion of drugs into body cavities (rectal, vaginal)
10. Use of the desired vehicle for insoluble drugs

Different finished dosage forms are listed on the FDA website as “Dosage Forms.” Dosage forms can be classified into two ways: their physical form and their route of administration. Types of physical forms are solid, semi-solid, liquid, and gaseous. In addition, oral, topical, rectal, parenteral, vaginal, inhaled, ophthalmic, and otic are routes of administration. Some common dosage forms are discussed below:

Solid Dosage Forms:

• Tablets: Tablets are solid dosage forms containing granulated or powdered drugs that are compressed or molded into round or other shapes. Examples of tablets are Aspirin, Clomipramine, Doxycycline Hyclate, Montelukast Sodium, etc.
• Capsules: Capsules are one of the most famous forms of oral administration. They are small containers made of gelatin. Hard-shelled capsules are generally used for dry, powdered ingredients. Soft-shelled capsules are used for oils and active ingredients dissolved or suspended in oil. Examples of Capsules are Acetaminophen, Amoxicillin, Azithromycin, Cefadroxil, Diclofenac Sodium, Morphine Sulfate, etc.
• Powders: Powders are medicinal substances in a dried and finely divided form and can be used externally and internally. Clotrimazole, Povidone Iodine, and Neomycin + Bacitracin are some examples of powders.

Semi-solid Dosage Forms: 

• Creams: Creams are semi-solid emulsions, mixtures of oil and water. Betamethasone Valerate is an example of a skin cream.
• Pastes: Pastes are ointments into which a high percentage of insoluble solid has been added. 
• Gels: Gels are colloidal aqueous suspensions of hydrated inorganic substances. Examples of gels are Lidocaine and Sildenafi
• Suppositories: Suppositories are a mixture of drugs with a firm base that can be molded in shapes suitable for insertion into a body cavity. Diclofenac Sodium, Domperidone, Naproxen, Phenylephrine, Progesterone are some suppositories.

Liquid Dosage Forms: 

• Syrups: A concentrated aqueous sugar solution, usually sucrose, added to medications. Flavored syrups are a convenient form of masking disagreeable tastes. Amoxicillin + Potassium Clavulanate, Azithromycin, Dihydroartemisinin + Piperaquine Phosphate, Fluconazole, Itraconazole are some dry syrups.
• Solutions: Oral solutions are clear liquid preparations for oral use containing one or more active ingredients dissolved in a suitable vehicle. Dexamethasone Sodium Phosphate, Moxifloxacin, Neomycin Sulfate + Dexamethasone Sodium Phosphate, Silver Nitrate are some ophthalmic solutions.
• Suspensions: They are subdivided into oral, topical, injectable, otic and, rectal suspensions. An injection is an infusion method of putting liquid in the body, usually with a hollow needle, a syringe pierced through the skin to a sufficient depth for the material to be forced into the body. Acyclovir, Atenolol, Chloroquine Phosphate, Lidocaine, etc are injectables.
• Emulsions: Pharmaceutical emulsions are liquid dispersed systems in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible. 
• Sprays: They are a solution of one or more drugs in oil or water, administered by atomizers. Benzocaine, Lidocaine, Oxytetracycline HCl are examples of sprays.

Gaseous Dosage Forms: 

• Aerosols: Aerosols are suspensions of drug particles or drug solutions in the air. They are used to inhale drug delivery to the lung. Volatile propellants are frequently used as vehicles for pharmaceutical aerosols.
• Inhalers: Inhalers are drugs that can be carried into the nasal passages with inhaled air because of their high vapor pressure. Beclometasone Dipropionate, Fluticasone Propionate, Salbutamol are some inhalers.

Conclusion:

With technological advancements, innovative dosage forms are boosting the market. Regardless, solid dosage forms remain prevalent amongst other dosage forms for the large populations of the developing world. 

NEWEDGE Overseas has a wide range of Finished Dosage Forms that include, but are not limited to, tablets, capsules, ointments, syrups, injectables, and eye & nasal drops. Kindly contact us for your finished dosage form requirements. 

Over the past few years, pharmaceutical companies across the globe have been emphasizing more on the safety, quality, and efficacy of their drug products. As a result, the Pharmaceutical industry spends enormous resources and money on their new drug development. Analytical method development and validation are critical aspects of the drug development process to achieve reliable analytical data. Regulatory and government bodies such as FDA, ICH, and EMA have guided method development and validation with “Analytical Procedures and Methods Validation for Drugs and Biologics,” “ICH Q2(R1)“, and “Bioanalytical Method Validation.”

Developing effective, reliable, and accurate methods from the initial stage of product development is an arduous task as the process is complex and time-consuming. Thus, pharmaceutical companies require qualified scientists with a deep understanding of current regulations and relevant chemistries with state-of-the-art instrumentation. Research and development, quality control, and quality assurance are the three central departments involved in this process.

Analytical Method Development:

Analytical methods are essential to ensure the drug substance and product’s identity, strength, quality, purity, and potency. Methods are developed to support drug testing against specifications during manufacturing, quality release operations, and long-term stability studies. Methods may also support safety and characterization studies or evaluations of drug performance.
The most common types of analytical procedures as per ICH are:

1. Identification tests
2. Quantitative tests of the active moiety in samples of API or drug product or other selected component(s) in the drug product
3. Quantitative tests for impurity content
4. Limits tests for the control of impurities

Early in developing a new analytical procedure, the scientists should select the choice of analytical instrumentation and methodology based on the intended purpose and scope of the analytical method. The parameters that may be evaluated during method development are specificity, linearity, limits of detection (LOD), quantitation (LOQ), range, accuracy, and precision. In addition, the robustness of the method is another criterion of early-stage assessment for selecting a suitable method. Finally, evaluation of a method’s performance may include analyses of samples obtained from various stages of the manufacturing process, from in-process to the finished product.

Analytical Method Validation:

The objective of validating an analytical procedure is to demonstrate that it is suitable for its intended purpose. Any analytical method applied to a pharmaceutical product under current Good Manufacturing Practices (cGMPs) requires validation. The methods used to produce data supporting the production of pharmaceuticals or regulatory filings (with FDA) need to be validated before use. Validated analytical methods support a drug’s characterization, quality control, and manufacturing batch records.

Typical validation characteristics which should be considered as per ICH Q2(R1) and the USP chapter <1225> Validation of Compendial Procedures are listed below:

• Accuracy: The accuracy of an analytical procedure expresses the closeness of agreement between the value, which is accepted either as an actual conventional value or an accepted reference value, and the value found.

• Precision: The precision of an analytical procedure expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. The precision may be considered at three levels: repeatability, intermediate precision, and reproducibility.

• Repeatability: Repeatability expresses the precision under the same operating conditions over a short time interval. Repeatability is also termed intra-assay precision.

• Intermediate Precision: Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.

• Specificity: Specificity is the ability to assess the analyte unequivocally in the presence of components expected to be present. Typically these might include impurities, degradants, matrices, etc. Other supporting analytical procedures may compensate lack of specificity of an individual analytical procedure.

This definition has the following implications:

1. Identification is made to ensure the identity of an analyte.
2. Purity Tests are made to ensure that all the analytical procedures are performed to allow an accurate statement of the content of impurities of an analyte.
3. An Assay test (content or potency test) is done to provide an exact result that allows an accurate statement of the content or potency of the analyte in a sample.

• Detection Limit: The detection limit of an individual analytical procedure is the lowest analyte in a sample that can be detected but not necessarily quantitated as an exact value. 

• Quantitation Limit: It is a characteristic of quantitative assays for low compounds in sample matrices, such as impurities in bulk drug substances and degradation products in finished pharmaceuticals.

• Linearity Range: The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample. 

• Robustness: The robustness of an analytical procedure is a measure of its capacity to remain unaffected by minor but deliberate variations in method parameters and indicates its reliability during normal usage.

Conclusion:

Analytical method development and validation are continuous and interconnected activities conducted throughout the drug development process. Further, several companies provide analytical method development and validation services for new drugs. These companies are commonly known as contract development and manufacturing organizations (CDMOs).

At NEWEDGE Overseas, we offer Analytical Method Development and Analytical Method Validation services. Our services include drug assessment that encompasses testing and providing information regarding various drugs’ potency, stability, bioavailability, and effect. We also undertake to characterize analytes to ascertain their biological and chemical properties. These services facilitate cost-optimization and help minimize drugs’ efficiency, precision, and accuracy.

While the pandemic was a wave of economic disruptions for many industries, it has blown some exemplary achievements to the Indian pharmaceutical industry. The pharmaceutical industry in India is currently valued at $41.7 bn. However, the pharmaceutical industry in India is expected to reach $65 bn by 2024 and $120 bn by 2030. Moreover, in August 2021, the Indian pharmaceutical market increased at 17.7% annually, up by 13.7% in July 2020. According to India Ratings and Research, the Indian pharmaceutical market revenue will be over 12% Y-o-Y in FY22.

India ranks 3rd worldwide for production by volume and 14th by value. In addition, India has the highest number of US-FDA compliant Pharma plants outside of the USA. It is home to more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities.

Andhra Pradesh, Gujarat, Maharashtra, and Goa are the major pharmaceutical manufacturing clusters in the country. The bulk drug clusters are located primarily in Ahmedabad, Vadodara, Mumbai, Aurangabad, Pune, Hyderabad, Chennai, Mysore, Bangalore, and Visakhapatnam (Vizag).

The pharmaceutical hubs offer investment opportunities to produce API or bulk drugs, vaccines, nutraceuticals, food and drug testing, clinical research, research and development, and contract research/manufacturing. Multinational pharmaceutical corporations outsource these various activities and help the sector’s growth. As a result, the Indian Pharmaceutical companies have a promising future. We will discuss prominent aspects of the industry and outline the growing Indian pharmaceutical industry.

India is the largest provider of generic drugs in the global pharmaceutical industry

• India is the largest provider of generic drugs globally. India’s generic drug producers hold a strong position in the global supply chain and play an integral role in developing the pharmaceutical industry. The pharma industry in India produces around 20% to 24% of the global generic drugs.
• Indian pharmaceutical sector supplies 40% of generic demand in the US and 25% of all medicines in the UK. The pharmaceutical industry in India offers 60,000 generic brands across 60 therapeutic categories. 
• Indian pharmaceutical companies supply over 80 percent of the anti-retroviral drugs used globally to combat AIDS (Acquired Immuno Deficiency Syndrome). Furthermore, six domestic firms – Aurobindo, Cipla, Desano, Emcure, Hetero Labs, and Laurus Labs have a sublicense with the UN-backed Medicines Patent Pool to manufacture anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

Increased profits in the pharmaceutical industry from exports of the pharmaceutical products

The country’s pharmaceutical sector contributes 6.6% to the total merchandise exports. India exports around 40% of its pharmaceutical products to more than 200 countries globally. Of these, 55% of the total exports constitute formulations, and the other 45% comprises bulk drugs.

According to the Pharmaceutical Export Council of India (Pharmexil), 55 percent of Indian exports are sent to highly regulated markets. The United States is the most lucrative generics market for India’s pharma industry. It is valued at around $60 billion and accounts for about 25 percent of India’s total shipment. India’s other important export destinations include the United Kingdom, South Africa, Russia, and Nigeria.

The significant growth rate in exports of pharmaceuticals over the past few years can be seen below:

• In 2017-18, India exported pharmaceutical products worth US$17.27 billion.
• In 2018-19, India’s pharmaceuticals exports were worth US$19.3 billion, showing a growth of 10.72 percent year on year.
• In 2019-20, exports grew to US$20.5 billion.
• By 2020-21, the industry estimates exports to grow to US$25 billion.
• This year, India’s pharma exports in the first six months amounted to US$11.38 billion, which was nearly 15 percent higher than in the same period last year.

Foreign investments in due to the low cost of productions

With the large concentration of multinational pharmaceutical companies in India, it becomes easier to attract foreign direct investments. Therefore, the pharma industry in India is one of the essential foreign direct investment encouraging sectors. India’s current foreign direct investment (FDI) policy allows acceptance of 100 percent FDI under the automatic route in greenfield pharmaceutical projects. It also allows 74 percent FDI acceptance under the automatic route in brownfield projects – upwards of which can still be allowed through the government approval.

India is also emerging as a preferred destination for contract manufacturing organizations. Indian contract manufacturing companies are gaining popularity because India has a low cost of production, low R&D costs, an innovative scientific workforce, and a large number of national laboratories that have the potential to steer the industry ahead. As per industry analysts, the manufacturing cost in India is approximately 33 percent lower than that of the US. Thus more companies are directing their manufacturing outsourcing in India and focusing more on their new drug discoveries.

Hold of the API industry

The Indian Pharmaceutical Industry is one of the biggest producers of active pharmaceutical ingredients (API) in the international arena. India has more than 262 API manufacturing USFDA approved plants. India is 3rd most prominent market for APIs globally and has an 8% share in the Global API Industry. API pharma companies in India produce 500+ different APIs, and it contributes 57% of APIs to prequalified list of the WHO.

Supply of vaccines during and before the pandemic

India is the largest producer of vaccines worldwide, accounting for around 60% of the total vaccines in 2021. In addition, India’s pharmaceutical industry is among the leading global producers of cost-effective generic medicines and vaccines. It supplies 20 percent of the global demand by volume and 62 percent of the global demand for vaccines. Therefore, it is expected to play a vital role in meeting the global demand for COVID-19 vaccines, especially for low and middle-income countries.

As of May 2021, India supplied a total of 586.4 lakh COVID-19 vaccines, comprising grants (81.3 lakh), commercial exports (339.7 lakh), and exports under the COVAX platform (165.5 lakh) to 71 countries.

The above-discussed facts prove that the pharmaceutical sector is highly profitable for the Indian economy and a global benchmark.

For more such insights, stay tuned to our website https://newedgeoverseas.com/.

Contract Manufacturing Organizations, also called trusted strategic partners, are currently in the limelight in the pharmaceutical industry. With the increase in sophisticated technology and to fulfill the demands of the latest trends in the industry, many pharmaceutical companies are shifting their manufacturing to contract manufacturing organizations. As a result, the global contract manufacturing organization (CMO) market size valued at USD 92.42 billion in 2018 is projected to reach USD 188.07 billion by 2026, exhibiting a CAGR of 9.4% during the forecast period.

Further, the pandemic has been a turning point for the Indian CMO market in recent years. As a result, the Indian contract manufacturing organization market is expected to register a CAGR of 13.3% between 2021 and 2026.

With the complex manufacturing procedures and regulatory controls, the pharmaceutical companies seek long-term relationships with the CMO for more beneficial strategic deals. (For detailed insights on the selection of the contract manufacturing organization, kindly refer to our blog “How To Choose The Right CMO And CDMO Partners” on our website. However, we will focus on some key benefits of contract manufacturing organizations here:

1. Utilize their expertise, innovation, and insight to set new trends in the market

The time frame for developing a new medicine through product launch can take up to 15 years. In addition, research and clinical trials demand a lot of investment and specific involvement from many personnel. On the other hand, the CMOs have expert personnel handling the business of many companies for years. Hence, pharmaceutical companies can use their expertise, innovation, and insight to increase their business by outsourcing these activities to CMO. Further, companies also get an avenue for entering emerging markets which is a wiser choice for the unapproved products in the pipeline. New products are crucial for a company’s future. Teaming up with a strategic partner gives an advantage over R&D. Still, they can get their potential revenues.

2. Access to the latest equipment and facility

Buying and running a piece of new expensive manufacturing equipment for the mass production of pharmaceuticals is very burdensome. To keep up with this demand, outsourcing manufacturing to CMOs is convenient. They have the latest equipment, qualified workforce, and facilities to carry out larger productions swiftly.

3. Leverage their high capacity framework

When the companies get regulatory approval for their drugs, large quantities of products are required for marketing and distribution. Unfortunately, many companies do not have adequate facilities and equipment to meet more extensive demands. Thus, contract manufacturing organizations can be helpful in this kind of scenario. Companies can use higher capacities of CMOs and focus on other core profit-making activities.

4. Superior control over quality and regulations

Contract manufacturers have robust control over quality management. In India, most contract manufacturers follow best manufacturing practices as per India’s Good Manufacturing Practices, under Schedule M of the Drugs and Cosmetics Act, 1940. Therefore, higher quality products give a competitive advantage in the market. In addition, CMOs have their niche in manufacturing practices with better regulatory checks in place. Consequently, the pharmaceutical companies get high-quality products from the contract manufacturers.

5. Cost-effectiveness

Researching and developing a new product can exceed $1 billion. In addition, the manufacturing costs account for roughly one-quarter of the company’s overall costs, which is considerably high. However, the CMOs have advanced manufacturing techniques that save time, cost and reduce wastage. Further, contract manufacturing can help reduce costs in other areas, such as equipment, facilities, operators, product designs, machine maintenance, and labor work. As a result, with comparatively fewer capital assets relative to its operations, a company has more resources to respond to market trends and generate more remarkable recoveries on investments.

6. Increasing the scale of the business

Improved scalability is an additional benefit to the CMOs because they have long-term relationships with the vendors and thus can produce bulk material at competitive prices. As a result, companies can increase the scale-up of their business without paying any extensive amount.

7. Risk Mitigation

The contract manufacturers help ensure a constant business flow, and thus, it becomes easy to respond to the varying market demands. It is challenging for the pharma company to commercialize extra capacity if the expected volume does not go well. In contrast, a CMO co-investing with a pharma company can reduce its exposure by marketing excess capacity to other customers and mitigating the risk.

8. Acquiring a competitive advantage in the market

CMOs can help gain pharmaceutical companies easy access to the local markets. In addition, they can get fast tract marketing organizations with their practical strategies as they have an admirable reputation of years with local government. Hence CMOs can help the companies get a competitive edge for entering a new market.

Conclusion

Pharmaceutical companies can cost-effectively provide quality products and increase overall productivity and efficiency by partnering with contract manufacturing organizations. The bottom line is that CMOs offer an extensive array of value-added services and preferred partners in current times.

At NEWEDGE Overseas, we offer solutions that are standardized and tailored as per your specific needs and requirements to become your trusted collaborators in the field of contract manufacturing. In addition, with our capability to handle multi-ton synthesis, we can help you reduce the turnaround time and the quality of your supplier portfolio. With all these, we become your one-point solution for all your requirements, reducing your outsourcing qualification interventions for superior supply chain management.

• We provide API and advanced intermediate synthesis exclusively complying with the latest regulatory requirements as per the highest quality standards and cGMP.
• We also manufacture early-stage intermediates and building blocks with our non-GMP capabilities and expertise.
• From start-ups and MSMEs to globally established corporations, we cater to all.
• Leveraging the latest technologies, we are innovative in our research and chemical experimentation.
• From grams to tons, our production scale exceeds volumes of your expectations.
• Our scientifically driven project management team evaluates, manages, and implements different projects per the client’s expectations.
• For FDFs, we provide every kind of contract manufacturing service irrespective of the dosage form.

Regulatory agencies aim to protect human health in global pharma. We will discuss ten reputed regulatory bodies of the global pharma industry here.

Regulatory agencies are the governing bodies aiming to protect human health in the global pharmaceutical industry. Therefore, they play a crucial role in meeting the requirements of legal procedures related to drug development. In addition, regulatory agencies ensure healthcare products’ safety, efficacy, and quality, and compliance with statutory duties. Further, the agencies periodically check the production sites for new and previously established products and procedures.

With the growing presence of pharmaceutical companies in more than 100 countries, most countries have established pharmaceutical legislation and regulatory requirements. Regulatory bodies issue various guidelines on the drug development process, licensing, manufacturing, marketing, patenting, registrations, quality control, good laboratory practices, handling of OTC drugs, packaging, labeling, storage, etc.

Furthermore, the pharmaceutical industry must comply with national regulations and international regulations if their product is implied for the international market. They have the authority to impose heavy penalties and product recalls in case of non-compliance. A list of Globally identified websites of medicines regulatory authorities is provided by the WHO. Out of these, we will discuss ten reputed regulatory bodies of the global pharma industry here.

1. FDA

The Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products. FDA is also responsible for advancing public health by helping to speed innovations that make medicines safer, more effective, and more affordable.

2. MHRA

The Medicines & Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring the proper use of medicine and medical devices. The MHRA is an executive agency of the Department of Health.

3. ANVISA

The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

Anvisa’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing, and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.

4. TGA

The Therapeutic Goods Administration (TGA) is the regulatory authority for the Australian pharmaceutical industry. The TGA oversees and regulates numerous therapeutic goods, including prescription medicines, vaccines, and medical devices. The site contains information specific to consumers, health professionals, and industry manufacturers. It also lists recent pharmaceutical recalls and alerts.

5. CDSCO

The Central Drugs Standard Control Organization in India sets standards and regulatory measures for medications. Further, the organization guides on health issues and medicines. They also regulate the standards of imported drugs and clinical research in India. Various regulatory documents and forms are available to download for free in PDF from the website.

6. WHO

WHO (World Health Organization) is the United Nations specialized agency for health. It is responsible for providing leadership on global health matters shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In addition, it is the United Nations agency that connects nations, partners, and people to promote health, keep the world safe, and serve the vulnerable. So everyone can attain the highest level of health.

7. ICH

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss pharma-related scientific and technical aspects and develop guidelines. Since its inception in 1990, ICH has gradually evolved to respond to increasingly global developments in the pharmaceutical sector.

8. EMA

The European Medicines Agency (EMA) protects and promotes public health by evaluating medicines. The EMA provides recommendations on the quality and safety of medicines. In addition, they apply evaluation procedures to help bring new medicines to the European Union.

9. HEALTH CANADA

Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible and works to reduce health risks. They focus on product safety, environmental and workplace health, food and nutrition, health and science research, drugs and health products, etc.

10. Egyptian Drug Authority (EDA)

In 2008, the Ministry of Health established the Egyptian Drug Authority (EDA) to have an independent regulatory body responsible for all pharmaceutical-related activities. It is similar to the function of India’s FDA in the United States. This establishment was seen as a landmark restructuring in the Egyptian pharmaceutical industry. There had yet to be an independent and organized body to manage pharmaceutical regulatory affairs beforehand.

As a Global Pharma, NEWEDGE Overseas exports a wide range of products to more than 40 countries. Every product that passes through the NEWEDGE supply chain be it raw material or an end-product adheres to all requisite regulatory compliances making it safe for consumption. In addition, our regulatory audits ensure that the products we offer and the processes we employ accurately comply with the regulatory dictates of specific countries.

The Global Pharma export industry has witnessed unprecedented times in the past few years. While the demand for healthcare products to fight pandemics increased, some products simultaneously faced a downturn. According to the Pharmbiz report, “the growth of global pharma market decreased by 1-2 percent in 2020”. However, the export from the Indian Pharmaceutical companies is currently flourishing. “The exports of drugs and pharmaceuticals from India reported a 4.58 percent growth for the three months ending June 2021 at $5.78 billion compared to $5.53 billion during the same period last year.”

Control of robust export and distribution lines in the pharmaceutical industry is challenging. Although the pharmaceutical industry implements numerous ways to manage exports smoothly, the following are some risks and challenges in pharma export.

1. Maintaining appropriate storage conditions during export

Be it an API, an excipient, or finished goods, maintaining adequate storage conditions is an essential parameter for the safety and efficacy of pharmaceutical products. Storage criteria vary from product to product. For example, most pharmaceuticals require to be stored at room temperature, whereas some unique products require cold storage conditions.

Suppose appropriate storage conditions are not managed during exports. In that case, it directly affects the quality of the product and the consumer’s health. Moreover, suppose the products deteriorate during transport. In that case, it can cause a recall from the market, affecting the manufacturer’s reputation and resulting in wastage. Hence, it becomes an arduous task to maintain storage conditions during export from the warehouse to the pharmacy store.

2. Maintaining records of the distribution line

The pharmaceutical distribution line consists of an organized network of producers, wholesalers, and distributors who collectively make products available to consumers. To sustain for a longer time in the market, companies need to ensure proper distribution of products. However, in developing countries, where many pharmaceutical companies haven’t adopted digital handling modes of their supply, it isn’t easy to track all the transactions. Sometimes, shipment records are not managed well, and there are no logs of the missing products during transport. Moreover, one major obstacle of this system is that the health authorities have not imposed strict and detailed policies for the pharmaceutical distribution system. As a result, there is a lack of control over the distribution chain to trace the exports.

3. Handling supply of products during shortage/emergencies

Many countries do not meet the demands of drugs and preventive medical supplies during emergencies, especially during contingencies like disease outbreaks or the onset of a pandemic. With limited manufacturers and suppliers of shortage products, it becomes challenging to meet the requirements in countries with a large population. Moreover, with the travel restrictions and export/import bans, the supply of products gets affected. These factors sometimes lead to fake and illegal supplies of medical products during emergencies.

4. Managing the supply chain effectively

Regulatory agencies have increased pressure for quality pharmaceutical products to ensure consumer protection. Unlike food, consumers can not detect faults in medicinal products through taste, smell, sight, touch, or appearance. Thus, it is imperative to keep the quality of products intact throughout the supply chain. The pharmaceutical products transit from manufacturers/suppliers to pharmacies/clinics in the supply chain. In this process, there are many hurdles such as timely delivery of products, sustenance of temperature, inventory management, track of expired products, etc.

5. Adhering to rules and regulations of various countries

There is a vast difference in the drug distribution systems of developing and developed countries. Most of the national wholesale drug market is operated by a few firms in advanced countries. In contrast, hundreds or thousands of companies handle the wholesale drug market in developing countries, leading to poor drug distribution management. Moreover, it is difficult to export the same product in various countries, as the regulatory requirements vary from country to country.

6. Fear of counterfeit drugs

Global pharma is currently facing another challenge of counterfeit medicines due to weak supply chains. Counterfeit medicines are deliberately and fraudulently produced and mislabeled concerning identity and source to appear genuine products. One of the most significant risks of counterfeit medicines is that patients may not get the therapeutic benefit expected from the product. Furthermore, it affects the company’s reputation in the market. The industry and regulatory agencies are still working to dismantle this organized crime of counterfeit medicines.

Conclusion

We have discussed potential risks associated with the exports of pharmaceutical products. Therefore, the industry should follow the guidelines on “good distribution practices for pharmaceutical products” and take appropriate measures during exports.

Newedge Overseas exports a wide range of products to more than 40 countries in South East Asia, Latin America, Africa, Middle East, Europe, USA, and CIS region. It represents more than 500+ partnerships in India for our export markets. In addition, we have offices and a robust presence in India, Egypt, Ukraine, Iran, UAE, Colombia, USA, and Germany. With a robust mechanism in place, NEWEDGE Overseas undertakes due diligence of the supply chain and manages all due processes with commendable ease of operations. So kindly get in touch with us for the premium quality services, including competitive prices and timely delivery of consignments of your pharmaceutical requirements.

Nutraceutical is the amalgamation of two words Nutrients and Pharmaceuticals. Nutraceutical term has been derived from nutrition which is generally derived from plants or animals and used to provide the physiological benefit in protecting or treating the disease. Before further classification of Nutraceuticals, let us discuss an overview of the Nutraceutical industry in India and across the globe.

According to the joint study report by ASSOCHAM and RNCOS, the Indian nutraceuticals market is expected to reach a value of US$ 8.5 Billion by 2022. In addition, India’s nutraceutical industry is expected to hold at least 3.5 percent of the global market share by 2023. Furthermore, as per Allied Market Research, the global Nutraceutical market is growing at a CAGR of 7.04% and will reach USD 302,306 million by 2022. These results are proof of the rapidly growing nutraceutical industry due to their health benefits.

Now, we will drill down on the various types of Nutraceuticals. The food sources used as nutraceuticals are all-natural and can be categorized as below:

1. Dietary Fiber

Dietary fiber is the food material, more precisely the plant material that is not hydrolyzed by enzymes secreted by the digestive tract but digested by microflora in the gut. In simple words, dietary fiber includes the parts of plant foods your body can’t digest or absorb.

Your body breaks down and absorbs other food components such as fats, proteins, or carbohydrates. However, your body doesn’t digest fiber. Instead, it passes relatively intact through your stomach, small intestine, colon, and eventually out of your body.

Dietary fibers may be divided into two forms based on their water solubility.

• Insoluble dietary fiber: This type of fiber promotes the movement of material through your digestive system and increases stool bulk, so it can benefit those who struggle with constipation or irregular stools. Whole-wheat flour, wheat bran, nuts, beans, and vegetables, such as cauliflower, green beans, and potatoes, are good sources of insoluble fiber.
• Soluble dietary fiber: This fiber dissolves in water to form a gel-like material. It can help lower blood cholesterol and glucose levels. Soluble fiber is found in oats, peas, beans, apples, citrus fruits, carrots, barley, and psyllium.

Water-soluble dietary fiber and dietary fiber & slim biome are some examples of nutraceutical products.

2. Probiotics

Probiotics are live bacteria and yeasts that are good for you, especially your digestive system. We usually think of these as microorganisms that cause diseases. But your body is full of bacteria, both good and bad. Probiotics are often called “good” or “helpful” bacteria because they help keep your gut healthy.

You can find probiotics in supplements and some foods, like yogurt. Doctors often suggest them to help with digestive problems. More examples of food rich in probiotics are unpasteurized sauerkraut and kimchi, miso soup, soft cheese, enriched milk, naturally fermented sour pickles, and sourdough bread. Probiotics and Enzymes, pre-probiotics, probiotics 10, probiotics 20, probiotics are known nutraceuticals.

3. Prebiotics

Prebiotics are dietary ingredients that beneficially affect the host by selectively altering the composition or metabolism of the gut microbiota. Prebiotic consumption helps improve metabolism as it generally promotes the Lactobacillus and Bifidobacteria growth in the gut.

Scientific literature indicates that increasing prebiotic fiber intake supports immunity, digestive health, bone density, regularity, weight management, and brain health. Foods rich in prebiotic fiber are onions, garlic, wheat bread/bran, asparagus, barley, apple with skin, oatmeal, chicory roots, banana, tomato, beans, peas, etc. Pre-probiotic with zinc for children is an example of a prebiotic nutraceutical product.

4. Polyunsaturated fatty acids

Polyunsaturated fatty acids (PUFAs) are also called “essential fatty acids” as these are crucial to the body’s function and are introduced externally through the diet. They are divided into omega-3 (n-3) and omega-6 (n-6) polyunsaturated fatty acids, differing in the first double C-bound position. Studies suggest that omega-3-fatty acids are helpful in cardiovascular diseases as they prevent irregularities in the force or rhythm of the heart and promote the reduction of lipid concentrations in the serum. Furthermore, omega-3-oils are helpful in premature infant health, bipolar and depressive disorders, dysmenorrhea, and diabetes. Sources of PUFA include walnuts, sunflower seeds, sesame seeds, peanut butter and peanuts, flaxseed, poppy seed, and avocado/ olive/ safflower oils. In addition, omega-3 capsules, gels, fish oil are some popular nutraceutical products.

5. Antioxidant vitamins

Vitamins like vitamin C, vitamin E, and carotenoids are collectively known as antioxidant vitamins. Antioxidants are our first line of defense against free radical damage and are critical for maintaining optimum health and wellbeing. In addition, these vitamins act singly and synergistically to prevent oxidative reactions leading to several degenerative diseases, including cancer, cardiovascular diseases, cataracts, etc. These vitamins are abundant in many fruits and vegetables and exert their protective action by free-radical scavenging mechanisms. Some examples of antioxidant nutraceuticals are Vitamin C (immunity booster), Vitamin E (Hair and skin products), and multivitamins and minerals.

6. Polyphenols

Polyphenols are natural phytochemical compounds in plant-based foods, such as fruits, vegetables, whole grains, cereals, legumes, coffee, wine, and cocoa. There are approximately 8,000 different classes of polyphenols, the essential being flavonols, flavones, flavan-3-ols, flavanones, and anthocyanins.

Dietary polyphenols can affect numerous cellular processes like gene expression, apoptosis, platelet aggregation, intercellular signaling, which have anti-carcinogenic and anti-atherogenic implications. Moreover, polyphenols also possess antioxidant, anti-inflammatory, anti-microbial, and cardioprotective activities and prevent neurodegenerative diseases and diabetes mellitus.
Red wine, dark chocolate, tea, and berries are some of the best-known sources of polyphenols. Yet, many other fruits, vegetables, nuts, grains, and spices also offer significant amounts of these compounds. For example, green tea polyphenols are widely used nutraceuticals in the market.

7. Spices

Spices are esoteric food adjuncts that have been used for thousands of years to enhance the sensory quality of foods. As per recent research, dietary spices in their minute quantities have antioxidative, anti-inflammatory, immune-modulatory effects on cells. As a result, they have an immense influence on human health. Moreover, a wide range of spices is beneficial for gastrointestinal, cardiovascular, respiratory, metabolic, reproductive, neural, and other systems. Some spices like turmeric, red pepper, black pepper, clove, ginger, garlic, coriander, rosemary, saffron, cardamom, coriander seeds, basil, and cinnamon are vigorously used in various products because of their benefits. For example, amla, cardamon, cinnamon are used in the immunity booster product Chavanprash.

For more scientific details on Nutraceuticals, please visit the article on the Role of nutraceuticals in human health.

Conclusion:

There is an excellent market for the manufacturers and suppliers of Nutraceuticals because of their proven disease prevention capabilities. In addition, consumers are choosing more Nutraceutical products to maintain overall health and indulge in some self-medication.

At NEWEDGE Overseas, we provide contract manufacturing, branding, packaging, and labeling of nutraceuticals. Kindly contact us for various standard and made-to-order nutraceuticals in demand due to their additional therapeutic value.

The Pharmaceutical Industry has been working enormously for the well-being of humankind for thousands of years. Over the past few years, the industry has successfully produced advanced medications and drugs to cure many lethal diseases. In addition, pharmaceutical companies constantly strive towards innovations and research for the betterment of patients.

With every innovation, highly skilled job openings are promoted, and industry workers gain more scientific knowledge, expedite capital formation and long-term economic growth. Moreover, the pharmaceutical industry is essential for international competitiveness. As a result, several countries are economically involved in producing, selling, and exporting pharmaceutical products. Here, we will discuss the potential and statistics, and facts of the multi-billion-dollar global pharmaceutical industry across various countries.

Egypt

With over 120 domestic pharmaceutical companies, Egypt is among the largest producers and consumers of pharmaceuticals in Africa and the Middle East. As per the latest report of Egypt Healthcare, Regulatory and Reimbursement Landscape – CountryFocus, “The Egyptian pharmaceutical market was valued at EGP44.70B ($2.66B) in 2019, which is estimated to increase at a Compound Annual Growth Rate (CAGR) of 8% to EGP56.60B ($3.37B) in 2022. Furthermore, the market value is expected to increase to $3.94B by 2024.”

Ukraine

The pharmaceutical industry in Ukraine is amongst the ten biggest pharmaceutical industries in the Central and Eastern European (CEE) region. Ukraine’s drug market has not recovered from the 2014–2015 crisis, but it is constantly growing. The trend is likely to continue in the coming years. As a result, Ukraine’s pharmaceutical sector is one of the fastest-growing and most crisis-resistant consumer industries in the economy. The latest report says that the demand for pharmaceutical products increased in 2016-2020, with a CAGR for a specified period of 11.5%, while capital investments grew at an average rate of 16%.

Turkey

The Turkish pharmaceutical industry ranks 7th in Europe and 16th in the world in market size. However, Turkey has a significant opportunity to become essential services and pharma products supplier for neighboring regions. With a total export potential of USD 8 billion, the market will reach TR 45.6 billion in 2023.

The Turkish pharmaceuticals industry is valued at approximately US$6 billion and represents around 0.5% of the global pharmaceutical market of US$1.2 trillion, having grown steadily in the past decade. Besides increasing its output, the industry has also committed to more R&D projects and manufacturing higher-value drugs.

South Korea

The pharmaceutical market in South Korea is on the increase and is expected to reach more than US$20 billion by 2020. According to a report by research and consulting firm GlobalData, the South Korean pharmaceutical market will observe a Compound Annual Growth Rate (CAGR) of 2.4%, increasing from US$18.6 billion in 2016 to US$20.4 billion by 2020. The government’s increasing focus on generics to reduce healthcare expenditure comes from the robust growth of the pharmaceutical sector.

Colombia

Colombia has a stable and attractive health system. With a population of 50 million, Colombia is the third most populous country in Latin America (after Mexico and Brazil), and 95% of the population is insured under the General Social Security Health System. In addition, Colombia has a diverse product portfolio for the pharmaceutical sector, where half of all sales are in brand-name products and the other half in generic products.

In 2019, the pharmaceutical market in Colombia was worth USD 4.795 billion. That same year, production reached an estimated value of USD 2.944 billion, led by digestive and metabolic health products. Forecasts suggest a sustained growth of 3% for this market by 2022.

Brazil

As the world’s sixth most populous country, Brazil represents an enormous market opportunity in Latin America for multinational pharma companies. Valued at around $23 billion by EY, a global consulting agency, Brazil represented the seventh largest pharma market in the world in 2018.

According to research and consulting firms, the Brazilian pharmaceutical market will expand in value from $29.4 billion in 2014 to reach approximately $47.9 billion by 2020, representing a solid Compound Annual Growth Rate (CAGR) of 8.5% GlobalData.

Mexico

Mexico, which has over a hundred million inhabitants, has become the world’s ninth biggest pharmaceutical market and the largest in Latin America, surpassing Brazil for the first time in its history. The country’s manufacturing infrastructure has also become one of the most modern globally, with many FDA-approved factories.

The sector already represents 1.18% of the national GDP, generating US$9,244 million (source Canifarma). The private sector market is valued at US$7,394 million, and the governmental market, through social security, is estimated at US$1,850 million.

Germany

Germany constitutes the primary European pharmaceutical market and the fourth largest worldwide. More than 500 pharmaceutical companies are located in Germany. Overall, the German pharmaceutical industry has 120,000 people (2019).

The German pharmaceuticals market size was valued at USD 41.4 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 6.0% from 2020 to 2027. Increasing patent applications focused on developing novel drug delivery systems, new drugs, and formulations is anticipated to boost the market for pharmaceuticals.

Conclusion:

Although countries like the USA, U.K., Canada, Japan, India, and Australia, are leading in the pharmaceutical sector, their achievements mentioned above are noteworthy and appreciable.

As a Global Pharma organization, NEWEDGE Overseas exports a wide range of products to more than 40 countries. We have offices and a robust presence in India, Egypt, Ukraine, Iran, UAE, Colombia, USA, and Germany. So kindly contact us for all kind of advanced pharma solutions.

The Active Pharmaceutical Ingredients market comprises the largest segment of the Indian pharmaceutical sector. India is the third-largest Pharmaceutical APIs market in Asia-Pacific. As per the BusinessWire report, the Indian API Market stood at USD 11806.93 million in FY 2021 and will grow at a CAGR of 12.24% during the forecast period. The Indian API Market is segmented based on the synthesis, source, therapeutic application, drug type, company, and region. Out of the various therapeutic categories, we will discuss 11 trending therapeutic categories of APIs and their uses. All the therapeutic categories, pharmacologic class, and formulary key drug types are available on the FDA website, and their scientific definitions are available on the Britannica website. However, we have delineated some of the most prominent APIs that rule the markets and are always in demand.

1. Anesthetics

Anesthetics are agents capable of inducing a total or partial loss of sensation, especially tactile sensation and pain. They can be induced as general ANESTHESIA to generate an unconscious state of mind or administered locally to induce numbness or lack of sensation at a targeted site.
Anesthetic drugs are widely used in medical operative procedures. Examples of anesthetics APIs are Lidocaine, Bupivacaine, Levobupivacaine, Ropivacaine, Mepivacaine, Prilocaine, Benzocaine, etc.

2. Analgesics

Analgesics are also called painkillers. Analgesics do not turn off nerves or change the ability to sense your surroundings, or alter consciousness. That is the main difference between Analgesics and Anesthetics. Analgesics may be classified into two types: anti-inflammatory drugs, which alleviate pain by reducing local inflammatory responses, and opioids, which act on the brain.

They are used to relieve pain after surgery, headache, cancer, menstruation, arthritis, nerve damage, etc. Examples of Analgesics are Diclofenac Sodium, Buprenorphine HCl, Phenazone, Sodium Salicylate, Meptazinol HCl, Acetaminophen, Aspirin, etc.

3. Antihistamine

Antihistamines are medicines that treat allergies by blocking the effects of histamine. An allergy is an immune response, or reaction, to substances (allergens) that are usually not harmful. When the oversensitive immune system recognizes an allergen, it launches a response. As a result, chemicals such as histamines are released. These chemicals lead to allergy symptoms.
Antihistamines treat allergy symptoms such as congestion, runny nose, sneezing, itching, hives, skin rashes, runny eyes, etc. Some examples of Antihistamines are Fexofenadine, Chlorpheniramine, Levocetirizine, Pheniramine Maleate, Hydroxyzine, etc.

4. Antifungal

The antifungal drug is the type of substance that acts selectively against fungal pathogens (disease-causing organisms) while treating fungal infections (mycosis). There are three major antifungal groups: the polyenes, the azoles, and the allylamines. These groups are distinguished primarily by chemical structure and mechanism of action.

Antifungals treat skin, nails, mucous membranes infections, jock itch, athlete’s foot, vaginal yeast infection, and ringworms. Some standard Antifungal APIs are Clotrimazole, Fluconazol, Miconazole, Terbinafine, Itraconazole, Piroctone Olamine, etc.

5. Antibiotic

Antibiotics fight bacterial infections/germs in people and animals. They kill the bacteria or keep them from copying themselves or reproducing.
Antibiotics are used to treat ear and sinus infections, dental infections, skin infections, meningitis, strep throat, bladder and kidney infections, bacterial pneumonia, whooping cough, etc. Some commonly used antibiotics are Amoxicillin, Azithromycin, Cefadroxil, Doxycycline, Erythromycin, Mupirocin, Piperacillin, Tedizolid, etc.

6. Antipsychotic

Antipsychotics are used to treat symptoms of psychosis such as delusions, hallucinations, paranoia, or confused thoughts. In addition, they are used to treat schizophrenia, severe depression, and severe anxiety. Antipsychotics are also helpful at stabilizing episodes of mania in people with bipolar disorders. Examples of antipsychotic drugs are Aripiprazole, Asenapine, Cariprazine, Chlorpromazine, Clozapine, Lurasidone, Olanzapine, Quetiapine, Ziprasidone, etc.

7. Vitamins

Vitamins are therapeutic nutrients, minerals, or electrolytes to support the body’s immune and healing systems, thereby altering the course and outcome of a disease process. Vitamin B complex, B1, B3, B12, Vitamin C, Vitamin D, Vitamin K, Vitamin K are vigorously used for various diseases. Some commonly prescribed vitamins are Ascorbic Acid, Benfotiamine, Folic Acid, Niacinamide, Hydroxocobalamin, Calcium Pantothenate, Alfacalcidiol, etc.

8. Antidepressants

Antidepressants are a class of drugs prescribed to relieve or treat symptoms of depression. There are different types of antidepressant drugs which can be popularly categorized as: tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and selective serotonin reuptake inhibitors (SSRIs). Other important groups include the norepinephrine reuptake inhibitors (NRIs), the serotonin-norepinephrine reuptake inhibitors (SNRIs), and the atypical antidepressants, a disparate group of agents with unique structural features and mechanisms of action.

The primary use for antidepressants is treating clinical depression in adults. However, they are also used for other mental health conditions and long-term pain treatment. Some majorly used antidepressants are Amitriptyline, Citalopram, Clomipramine, Doxepin, Escitalopram, Milnacipran, Sertraline, Paroxetine, Venlafaxine, etc.

9. Antidiabetic

Antidiabetics are drugs that work to lower abnormally high glucose (sugar) levels in the blood, which are characteristic of the endocrine system disorder known as diabetes mellitus. Antidiabetic drugs are commonly used to treat and manage diabetes. Antidiabetic drug examples are Alogliptin, Glimepiride, Glipizide, Metformin HCl, Pioglitazone, Saxagliptin, Sitagliptin, etc.

10. Cardiovascular

Cardiovascular drugs affect the function of the heart and blood vessels. Therefore, drugs that act on the cardiovascular system are most widely used in medicine. Examples of disorders in which such drugs may be helpful include hypertension, chest pain, heart failure, high cholesterol, and disturbances of cardiac rhythm. Some commonly used cardiovascular drugs are amlodipine Maleate, Clopidogrel, Dopamine HCl, Levosimendan, Trimetazidine HCl.

11. Anticancer

Anticancer drugs are also called antineoplastic drugs, effective in treating malignant or cancerous diseases. Common anticancer drugs include alkylating agents, antimetabolites, natural products, and hormones. In addition, several drugs do not fall within those classes but demonstrate anticancerous activities and thus are used to treat malignant diseases. Popular anticancerous drugs are Enzalutamide, Palbociclib, Ibrutinib, Ribociclb, Pemetrexed Disodium, etc.

NEWEDGE Overseas has a robust 2000+ Active Pharmaceutical Ingredients portfolio that includes many hard-to-find APIs consolidated over a decade. Kindly contact us for your APIs, FDFs, Intermediates, Nutraceuticals, or other requirements.