Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
01 1Cayman Pharma s. r. o.
02 1JOHNSON MATTHEY PHARMACEUTICAL MATERIALS IRELAND
03 1Pharmacia & Upjohn Company LLC
04 1YS Life Science Co. , Ltd.
01 4Epoprostenol sodium
01 1Czech Republic
02 1South Korea
03 2U.S.A
Registration Number : 221MF10112
Registrant's Address : ul. Pra(´)ce 657,277 11 Neratovice, Czech Republic
Initial Date of Registration : 2009-06-10
Latest Date of Registration : 2018-10-26
Registration Number : 221MF10006
Registrant's Address : 4OC Commercial Park Little Island Cork, Ireland
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-01-13
Registration Number : 218MF10929
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Registration Number : 222MF10209
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2010-07-29
Latest Date of Registration : 2022-02-24
A Epoprostenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epoprostenol, including repackagers and relabelers. The FDA regulates Epoprostenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epoprostenol 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 Epoprostenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epoprostenol supplier is an individual or a company that provides Epoprostenol active pharmaceutical ingredient (API) or Epoprostenol finished formulations upon request. The Epoprostenol suppliers may include Epoprostenol API manufacturers, exporters, distributors and traders.
click here to find a list of Epoprostenol 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 Epoprostenol Drug Master File in Japan (Epoprostenol JDMF) empowers Epoprostenol 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 Epoprostenol JDMF during the approval evaluation for pharmaceutical products. At the time of Epoprostenol 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 Epoprostenol suppliers with JDMF on PharmaCompass.
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