DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories Limited office and manufacturing site in Mexico
01 1Naproxen
01 1India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 219MF10208
Registrant's Address : Km. 4.5 Carretera Federal Cuernavaca-Cuautla 62578 Jiutepec, Morelos, Mexico
Initial Date of Registration : 2007-06-25
Latest Date of Registration : 2007-06-25
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A Calosen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calosen, including repackagers and relabelers. The FDA regulates Calosen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calosen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Calosen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Calosen supplier is an individual or a company that provides Calosen active pharmaceutical ingredient (API) or Calosen finished formulations upon request. The Calosen suppliers may include Calosen API manufacturers, exporters, distributors and traders.
click here to find a list of Calosen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Calosen Drug Master File in Japan (Calosen JDMF) empowers Calosen API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Calosen JDMF during the approval evaluation for pharmaceutical products. At the time of Calosen JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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