01 1Baxter Deutschland GmbH
01 1Mesna
01 1U.S.A
Registration Number : 223MF10085
Registrant's Address : Edisonstrasse 4,85716 Unterschleissheim, Germany
Initial Date of Registration : 2011-06-17
Latest Date of Registration : 2011-06-17
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A sodium, 2-mercapto-ethanesulfonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sodium, 2-mercapto-ethanesulfonate, including repackagers and relabelers. The FDA regulates sodium, 2-mercapto-ethanesulfonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sodium, 2-mercapto-ethanesulfonate 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 sodium, 2-mercapto-ethanesulfonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A sodium, 2-mercapto-ethanesulfonate supplier is an individual or a company that provides sodium, 2-mercapto-ethanesulfonate active pharmaceutical ingredient (API) or sodium, 2-mercapto-ethanesulfonate finished formulations upon request. The sodium, 2-mercapto-ethanesulfonate suppliers may include sodium, 2-mercapto-ethanesulfonate API manufacturers, exporters, distributors and traders.
click here to find a list of sodium, 2-mercapto-ethanesulfonate 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 sodium, 2-mercapto-ethanesulfonate Drug Master File in Japan (sodium, 2-mercapto-ethanesulfonate JDMF) empowers sodium, 2-mercapto-ethanesulfonate 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 sodium, 2-mercapto-ethanesulfonate JDMF during the approval evaluation for pharmaceutical products. At the time of sodium, 2-mercapto-ethanesulfonate 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 sodium, 2-mercapto-ethanesulfonate suppliers with JDMF on PharmaCompass.
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