What Are Active Pharmaceutical Ingredients (APIs)?
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- What Are Active Pharmaceutical Ingredients (APIs)?
What Are Active Pharmaceutical Ingredients (APIs)?
Active pharmaceutical ingredients (APIs) are substances that are contained in drugs to produce intended pharmaceutical effects. Drugs have efficacy because APIs in them work.
Ingredients and their amounts are indicated on the packages of OTC drugs. Those ingredients are APIs.
API Quality Management
APIs must be manufactured under a rigorous quality management system, just as pharmaceutical formulation products are.
Daito complies with various quality standards and regulations, including not only the Japanese Good Manufacturing Practice (GMP) standards but also quality control regulations imposed by the U.S. Food and Drug Administration (FDA). Therefore, the Company can manufacture APIs for U.S. markets too.