EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Hungary Ltd.
02 1Kyowa Pharma Chemical Co., Ltd.
01 1Alprostadil alfadex
02 1Japanese Pharmacopoeia alprostadil alpha dexfenfluramine (production only)
01 1France
02 1Japan
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 218MF10339
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2006-05-22
Latest Date of Registration : 2010-01-07
Japanese Pharmacopoeia Alprostadil Alphadex (for manufacturing only)
Registration Number : 218MF10946
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
A Alprostadil Alfadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil Alfadex, including repackagers and relabelers. The FDA regulates Alprostadil Alfadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil Alfadex 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 Alprostadil Alfadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil Alfadex supplier is an individual or a company that provides Alprostadil Alfadex active pharmaceutical ingredient (API) or Alprostadil Alfadex finished formulations upon request. The Alprostadil Alfadex suppliers may include Alprostadil Alfadex API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil Alfadex 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 Alprostadil Alfadex Drug Master File in Japan (Alprostadil Alfadex JDMF) empowers Alprostadil Alfadex 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 Alprostadil Alfadex JDMF during the approval evaluation for pharmaceutical products. At the time of Alprostadil Alfadex 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 Alprostadil Alfadex suppliers with JDMF on PharmaCompass.
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