EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Hungary Ltd.
02 1Kyowa Pharma Chemical Co., Ltd.
01 1Dinoprostone
02 1Ginoproston
01 1France
02 1Japan
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 230MF10136
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2018-09-21
Latest Date of Registration : 2018-09-21
Registration Number : 230MF10070
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2018-06-07
Latest Date of Registration : 2018-06-07
A Dinoprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dinoprostone, including repackagers and relabelers. The FDA regulates Dinoprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dinoprostone 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 Dinoprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dinoprostone supplier is an individual or a company that provides Dinoprostone active pharmaceutical ingredient (API) or Dinoprostone finished formulations upon request. The Dinoprostone suppliers may include Dinoprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Dinoprostone 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 Dinoprostone Drug Master File in Japan (Dinoprostone JDMF) empowers Dinoprostone 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 Dinoprostone JDMF during the approval evaluation for pharmaceutical products. At the time of Dinoprostone 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 Dinoprostone suppliers with JDMF on PharmaCompass.
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