Active Pharmaceutical Ingredients (API)
Active Pharmaceutical Ingredients (API)In drug regulatory affairs, an Active Pharmaceutical Ingredient (API) refers to the biologically active substance in a pharmaceutical product that produces the intended therapeutic effect. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) define APIs as the key components responsible for diagnosing, treating, curing, or preventing diseases.
The quality, safety, and efficacy of an API are fundamental in regulatory submissions, and strict guidelines exist for its manufacturing, testing, and approval. Regulatory bodies require pharmaceutical companies to submit Drug Master Files (DMFs) or Active Substance Master Files (ASMFs) containing detailed information about the API’s manufacturing process, impurity profile, stability data, and control measures. APIs must comply with Good Manufacturing Practices (GMP) to ensure consistency and purity.
APIs are classified into small molecules (chemically synthesized compounds) and biologics (complex molecules derived from living organisms). Regulatory agencies also assess APIs based on their polymorphism, solubility, bioavailability, and stability, which impact a drug’s effectiveness and safety.
Harmonization efforts through organizations like ICH (International Council for Harmonisation) help standardize API regulations globally. Additionally, stringent pharmacovigilance measures monitor APIs post-market to ensure continued safety. API compliance is essential in obtaining regulatory approvals, marketing authorizations, and post-approval changes, making it a critical aspect of drug regulatory affairs.
Masuu offers regulatory and quality assurance services to help pharmaceutical companies comply with international drug regulations and standards.
Their expertise covers:API Registration – Assisting companies in obtaining regulatory approval for Active Pharmaceutical Ingredients (APIs) by preparing and submitting required documentation (e.g., Drug Master Files (DMFs) or Active Substance Master Files (ASMFs)) to agencies like the FDA, EMA, or WHO.
GMP Audits – Conducting Good Manufacturing Practice (GMP) audits to ensure API manufacturers follow strict quality and safety guidelines. These audits help maintain high production standards, prevent contamination, and meet regulatory expectations.
Lifecycle Management – Managing the regulatory aspects of an API throughout its lifecycle, including updates to documentation, handling changes in manufacturing processes, responding to regulatory inquiries, and ensuring continued compliance with evolving regulations.