01 1Pharmacia & Upjohn Company LLC
01 1Betamethyl Epoxide
01 1U.S.A
Registration Number : 222MF10213
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2010-08-05
Latest Date of Registration : 2010-08-05
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A 16-Beta Methyl Epoxide; DB11 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 16-Beta Methyl Epoxide; DB11, including repackagers and relabelers. The FDA regulates 16-Beta Methyl Epoxide; DB11 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 16-Beta Methyl Epoxide; DB11 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 16-Beta Methyl Epoxide; DB11 supplier is an individual or a company that provides 16-Beta Methyl Epoxide; DB11 active pharmaceutical ingredient (API) or 16-Beta Methyl Epoxide; DB11 finished formulations upon request. The 16-Beta Methyl Epoxide; DB11 suppliers may include 16-Beta Methyl Epoxide; DB11 API manufacturers, exporters, distributors and traders.
click here to find a list of 16-Beta Methyl Epoxide; DB11 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 16-Beta Methyl Epoxide; DB11 Drug Master File in Japan (16-Beta Methyl Epoxide; DB11 JDMF) empowers 16-Beta Methyl Epoxide; DB11 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 16-Beta Methyl Epoxide; DB11 JDMF during the approval evaluation for pharmaceutical products. At the time of 16-Beta Methyl Epoxide; DB11 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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