01 1Excella GmbH & Co. K.G.
02 1Permakem Asia Co., Ltd.
01 1Estramustine Phosphate Sodium
02 1Estramustine phosphate sodium
01 1Gabon
02 1Japan
Registration Number : 217MF11130
Registrant's Address : 7-6, Nihonbashi Odenmacho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-11-09
Registration Number : 221MF10277
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2009-12-15
Latest Date of Registration : 2015-04-21
A Estramustine Phosphate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estramustine Phosphate Sodium, including repackagers and relabelers. The FDA regulates Estramustine Phosphate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium supplier is an individual or a company that provides Estramustine Phosphate Sodium active pharmaceutical ingredient (API) or Estramustine Phosphate Sodium finished formulations upon request. The Estramustine Phosphate Sodium suppliers may include Estramustine Phosphate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Estramustine Phosphate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Estramustine Phosphate Sodium Drug Master File in Japan (Estramustine Phosphate Sodium JDMF) empowers Estramustine Phosphate Sodium 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 Estramustine Phosphate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Estramustine Phosphate Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Estramustine Phosphate Sodium suppliers with JDMF on PharmaCompass.
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