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Which are the Critical Regulatory Documents Associated with APIs?

Critical Regulatory Documents Associated with APIs

API pharmaceutical is a renowned word in the pharmaceutical industry. API (Active Pharmaceutical Ingredient) or pharma ingredients are used in a finished pharmaceutical product (FPP) to furnish pharmacological activity. They directly affect the diagnosis, cure, mitigation, treatment, or prevention of disease or restoring, correcting, or modifying physiological functions in human beings. API is the biologically active component of a drug product that produces the intended effects. 

To manufacture or import Active Pharmaceutical Ingredient (API)/drugs to India, the company or the organization should seek prior approval from Drugs Controller General Of India (DCGI) for licensing to produce and distribute. In addition, to produce the drugs, the company should also follow the norms as stipulated by the Central Drugs Standard Control Organisation (CDSCO). Furthermore, API pharma companies in India should follow the FDA regulatory guideline Q7 to manufacture their APIs. Some critical regulatory documents associated with APIs are discussed below:

pharma ingredients are associated with regulatory framework


A drug master file is a document submitted to governmental bodies that contains all details of the manufacturing process of an API or medicine. For example, DMF includes information on the chemical properties of the API, the facilities used, the processes used, details on packaging, storage, etc. DMF is an essential document to protect the intellectual property of the manufacturer. Please refer to FDA guidance “Drug Master Files” for detailed insights.

Countries may have different guidance compared to other countries, so different types of DMF exist. For example, USDMF, ASMF (formally known as EDMF), Japanese DMF, Taiwan DMF, Brazil DMF, Mexico DMF, Canada DMF, China DMF, etc.


A CEP is a certificate of sustainability that proves that an API qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph. Eur. to the API itself. The API manufacturer submits a CEP as part of the market authorization process and will become the CEP holder of the document. The CEP is granted by the European Directorate for the Quality of Medicines (EDQM) but is recognized by other countries or institutes like the FDA. Furthermore, just like the DMF, the data submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.

Pharma Ingredients


A Certificate of Analysis (CoA) is a crucial document provided with a range of pharmaceutical products. It reports on the quality assessment of the production lot, ensuring that the released product meets the desired quality standards. The CoA commonly contains results obtained from individual product batch laboratory tests. There are different international standards to which a product can be tested, for example:

  • Ph. Eur. | EP – (European Pharmacopoeia)
  • USP – (United States Pharmacopeia)
  • BP – (British Pharmacopoeia)
  • JP – (Japanese Pharmacopoeia)
  • ChP – (Chinese Pharmacopoeia, also known as PPRC)
  • DAB – (German Pharmacopoeia)
  • Ph.Fr. – (French Pharmacopoeia)
  • Ph.Fr. – (Indian Pharmacopoeia)


A Material Safety Data Sheet (MSDS) is a product-specific document intended as a reference work for safe use, handling, and processing. It contains identifiers, chemical properties, health hazards, precautionary statements, and other related information for professionals working with the product.

Pharma Ingredients


A tech pack is a document containing all the technical information about the API. This document covers information from the R&D stage and includes stability data also.
A Technical Data Package (TDP) includes the technical design and manufacturing information to enable specific maintenance or production processes.

NEWEDGE Overseas has a robust 2000+ Active Pharmaceutical Ingredients portfolio that includes many hard-to-find APIs, consolidated over a decade. We provide necessary documents with APIs such as DMFs, CEPs, TECH PACK, TDP, COS, etc. Kindly contact us for your API requirements and advanced pharma solutions. 

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