In the pharmaceutical industry, Active Pharmaceutical Ingredients (APIs) are essential components that provide pharmacological activity in the finished products. These APIs play a crucial role in diagnosing, treating, and preventing diseases, as well as restoring and modifying physiological functions in humans. To manufacture or import APIs in India, companies must comply with strict regulations of the Drug Controller General of India (DCGI) and follow the guidelines of the Central Drugs Standard Control Board (CDSCO) and the FDA.
Regulatory documents such as the Drug Master File (DMF), the Certificate of Suitability (CEP), the Certificate of Analysis (CoA) and the Material Safety Data Sheet (MSDS) are fundamental in this process. These documents guarantee the confidentiality of the manufacturer’s intellectual property and ensure that the products comply with international quality and safety standards. Gaffel Representations, with its broad portfolio of 100 APIs, including many that are difficult to obtain, offers these crucial documents, supporting its commitment to high-quality, advanced pharmaceutical solutions.
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Source: Gaffel News Technical Area Newsroom