EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Hungary Ltd.
02 1YS Life Science Co. , Ltd.
01 2Alprostadil
01 1France
02 1South Korea
Registration Number : 220MF10064
Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary
Initial Date of Registration : 2008-02-25
Latest Date of Registration : 2016-12-20
Registration Number : 306MF10135
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2024-10-16
Latest Date of Registration : 2024-10-16
A Alprostadil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil, including repackagers and relabelers. The FDA regulates Alprostadil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil supplier is an individual or a company that provides Alprostadil active pharmaceutical ingredient (API) or Alprostadil finished formulations upon request. The Alprostadil suppliers may include Alprostadil API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil 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 Drug Master File in Japan (Alprostadil JDMF) empowers Alprostadil 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Alprostadil 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 suppliers with JDMF on PharmaCompass.
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