01 1Sucampo Pharma LLC
02 1Yonsung Fine Chemicals Co. , Ltd.
01 1Isopropyl unoprostone
02 1Isopropyl unoprostone "production-only"
01 1South Korea
02 1U.S.A
Registration Number : 227MF10230
Registrant's Address : 2-6-4 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2015-09-03
Latest Date of Registration : 2015-09-03
Isopropyl Unoprostone (For manufacturing purposes only)
Registration Number : 219MF10370
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2007-12-13
Latest Date of Registration : 2007-12-13
A Isopropyl Unoprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isopropyl Unoprostone, including repackagers and relabelers. The FDA regulates Isopropyl Unoprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isopropyl Unoprostone 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 Isopropyl Unoprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isopropyl Unoprostone supplier is an individual or a company that provides Isopropyl Unoprostone active pharmaceutical ingredient (API) or Isopropyl Unoprostone finished formulations upon request. The Isopropyl Unoprostone suppliers may include Isopropyl Unoprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Isopropyl Unoprostone 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 Isopropyl Unoprostone Drug Master File in Japan (Isopropyl Unoprostone JDMF) empowers Isopropyl Unoprostone 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 Isopropyl Unoprostone JDMF during the approval evaluation for pharmaceutical products. At the time of Isopropyl Unoprostone 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 Isopropyl Unoprostone suppliers with JDMF on PharmaCompass.
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