Brief profile: A pharmacopeia is a compendium or collection of drug information. The USP is one such pharmacopeia that is published by the United States annually. The trademark and copyrights of the United States Pharmacopoeia are owned by a nonprofit organization called Pharmacopoeial Convention ( also called USP ). The first edition of USP was […]
Brief Profile : ANDA is an application that is submitted to the FDA for a US generic drug approval. It is specifically sent to the FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, to approve a generic drug product. The FDA established this application in 1970. The term “abbreviated” is used for
An active pharmaceutical ingredient popularly known as API is the biologically active drug product component. API is a raw material and, also known as bulk drugs. As we know, pharmaceutical products, like a tablet or capsule, are usually composed of several ingredients. So, API is the primary ingredient. Other ingredients are commonly known as “excipients.” Excipients
What is an API or Active Pharmaceutical Ingredient? Read More »
