API supplier is an integral part of the pharmaceutical industry and so does the API (Active Pharmaceutical Ingredients) for manufacturing safe and effective drugs. However, only a limited number of companies have their API manufacturing facilities for their finished products.
Therefore, in the current scenario, many companies rely on API suppliers rather than in-house raw material manufacturing. Pharmaceutical companies are enhancing their productivity by taking help from API suppliers. Therefore, pharmaceutical companies in India must be vigilant while getting in association with an API supplier.
Following are five tips on selecting a standard API supplier for your company.
1) Check the Track Record of the Supplier
It is evident to run a meticulous background check on the API supplier to get high-quality APIs. Furthermore, procuring APIs should involve strategic planning and exhaustive research. The pharmaceutical companies can ask the following questions to the supplier:
• What is their current stand and reputation in the market?
• What are their financial capabilities and annual turnover?
• What is the entire range of their products?
• What are their production capabilities and unique qualities?
• What are their current business practices?
• Who are their past and present clientele?
• What are the reviews of the supplier’s clients?
• Which are their achievements in the field of API manufacturing?
• What practices do they follow to stay with regulatory compliance?
2) Assure Quality Parameters of the Supplier
Quality is of the utmost importance while choosing an API supplier. A reputed API supplier should have all parameters of quality checks in place from the manufacturing to final delivery. In addition, the supplier should check all raw materials, intermediates, packaging, and labeling materials in a standardized manner.
Moreover, API suppliers should have an efficient supply chain to safely, securely, and timely deliver the products. The supplier should follow documentation practices, have details on DMF as per WHO guidance, storage, and stability checks of the API. Along with these parameters, the supplier should maintain client confidentiality as well.
Companies can sign an agreement for the confidentiality and responsibilities of the API suppliers for quality products.
3) Check whether the supplier complies with regulations or not
API supplier’s reputation in the market and with the regulatory agencies affects procuring the company’s image in some or other way. Therefore, API suppliers must fully comply with the regulatory requirements of cGMP (current good manufacturing practices) guidelines, published on FDA, EMA, ICH, and other regulatory agency websites.
In addition, pharmaceutical companies should check the readiness of the supplier company for their quality checks on data integrity systems as well. Moreover, suppliers should be ready with their complete, organized, and appropriate documents on DMFs already filed with the Agency.
4) Take account of costing
For any pharmaceutical company, managing finance is a crucial factor. Hence, taking account of costing is essential while selecting the API supplier. For the long-term benefits of a relationship, a standard API supplier should be efficient and cost-effective.
Therefore, it is advisable to get quotations from several companies before choosing one supplier for your company. However, sometimes, the suppliers offer specific APIs at meager prices; in such cases, companies should check their history of warning letters and the quality of products.
Low prices of APIs may result in the downfall of the final product and the company in longer terms. Hence to prevent additional costs and significant shortfalls, the company should consider and discuss various factors with the supplier company as mentioned below.
• Sensible API cost
• Standards of their raw materials
• Customer services
• The global reach of their API
• Storage, warehouse facility
• International logistics facility
• Custom duties
• Sales services
• Insurance costs
• Development costs
• Shipping charges
• Compliance with regulatory agencies
• Co-operation throughout the project cycle
• Other fees
5) Promptness of the company for resolving issues
Trustworthy suppliers are those who ensure their API meets the current standards and regulatory requirements. In addition, companies need support from the suppliers for queries related to ANDA for approval. The prompt and proper response from the supplier company helps to resolve issues effectively and timely.
In this fast-changing and competitive industry, it is crucial to connect with an established API supplier by conducting in-depth research, as discussed above. At NEWEDGE Overseas, we have a robust 2000+ Active Pharmaceutical Ingredients portfolio that includes many hard-to-find APIs, consolidated over a decade. Kindly contact us for your API requirements.