what does api means in pharma

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The process of drug manufacturing is complex and requires rigorous quality control measures. API manufacturers are responsible for synthesizing, purifying, and preparing APIs for use in drug formulations. These manufacturers adhere to strict regulations set forth by health authorities such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to ensure that the APIs are safe, effective, and free from impurities.


Atypical active pharmaceutical ingredients are generally characterized by their uncommon chemical structures, mechanisms of action, or routes of administration. Unlike conventional APIs that may follow well-established pathways for synthesis and regulation, AAPIs can include novel compounds that are derived from unconventional sources, such as marine natural products or rare plant extracts, as well as compounds that are synthesized through innovative techniques.


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