Definition of APIs

According to the FDA, Active Pharmaceutical Ingredients (APIs) are the substances or mixtures of substances that are responsible for the therapeutic effect in a drug product. They are the key components that provide the intended pharmacological activity or effect in diagnosing, curing, mitigating, treating, or preventing diseases, or in affecting the structure or function of the body.

APIs form the basis of every final formulation product and are the core part of making safe and effective medicines. Mainly derivatives of the specialty chemicals/fine chemicals industry. At present, there are more than 2,000 kinds of raw materials in the world, and only a few large preparation manufacturers can produce raw materials by themselves, and none of them can produce all the raw materials they need.

Classification of Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients (APIs) can be classified into different categories based on various factors. Here are some common classification categories for APIs:

1. Chemical Classification: APIs can be classified based on their chemical structure, such as small molecules, peptides, proteins, nucleic acids, carbohydrates, or lipids.

2. Therapeutic Classification: APIs can be classified based on the therapeutic class or the intended use of the drug they are used in. Examples include APIs for cardiovascular drugs, anti-infectives, analgesics, antidiabetics, or anticancer drugs.

3. Source Classification: APIs can be classified based on their source of origin. This classification includes APIs derived from natural sources (e.g., plant extracts, animal tissues, or microorganisms) and those produced through chemical synthesis or biotechnological methods.

4. Pharmacological Classification: APIs can be classified based on their pharmacological activity or mechanism of action. This classification includes APIs acting on specific receptors, enzymes, or biological pathways.

5. Regulatory Classification: APIs can be classified based on regulatory considerations, such as their legal status, control measures, or scheduling. This classification may vary across different countries or regulatory authorities.