EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI Hungary Ltd.
02 1YS Life Science Co., Ltd.
01 1Samoh Pharmaceutical Co., Ltd.
02 1YS Life Science Co., Ltd.
01 2Alprostadil
01 1France
02 1South Korea
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-02-02
Registration Number : 20230202-210-J-1440
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary
Registrant Name : YS Life Science Co., Ltd.
Registration Date : 2024-02-06
Registration Number : 20240206-210-J-1611
Manufacturer Name : YS Life Science Co., Ltd.
Manufacturer Address : 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do
A Prostaglandin E1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prostaglandin E1, including repackagers and relabelers. The FDA regulates Prostaglandin E1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prostaglandin E1 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 Prostaglandin E1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prostaglandin E1 supplier is an individual or a company that provides Prostaglandin E1 active pharmaceutical ingredient (API) or Prostaglandin E1 finished formulations upon request. The Prostaglandin E1 suppliers may include Prostaglandin E1 API manufacturers, exporters, distributors and traders.
click here to find a list of Prostaglandin E1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Prostaglandin E1 Drug Master File in Korea (Prostaglandin E1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prostaglandin E1. The MFDS reviews the Prostaglandin E1 KDMF as part of the drug registration process and uses the information provided in the Prostaglandin E1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prostaglandin E1 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Prostaglandin E1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prostaglandin E1 suppliers with KDMF on PharmaCompass.
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