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Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
Ipca Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai. It produces theobromine, acetylthiophene, and p- bromotoluene as active pharmaceutical ingredients (APIs). Ipca sells these APIs and their intermediates globally. [ 6] It produces more than 150 formulations that include oral liquids, tablets, dry ...
An international nonproprietary name ( INN) is an official generic and nonproprietary name given to a pharmaceutical drug or an active ingredient. [2] INNs are intended to make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors. [1] The INN system has been coordinated by the ...
Toledo Pharmacal Company from Toledo, Ohio seen in 1905. Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Divi's Laboratories Limited is an Indian multinational pharmaceutical company and producer of active pharmaceutical ingredients (APIs) and intermediates, headquartered in Hyderabad. [ 5][ 6][ 2][ 7] The company manufactures and custom synthesizes generic APIs, intermediates. [ 8][ 9] The company also manufactures and supplies nutraceutical ...
Biocon. Biocon Limited is an Indian biopharmaceutical company based in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. [ 4] The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries, [ 5] including the United States and Europe. [ 4]