01 1Cambrex Profarmaco Milano Srl
02 1Syn-Tech Chem & Pharm. Co., Ltd.
01 1Hyons Co., Ltd.
02 1Samoh Pharmaceutical Co., Ltd.
01 2Epinephrine tartrate
01 1Taiwan
02 1U.S.A
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-09-05
Registration Number : 20190905-210-J-425
Manufacturer Name : Cambrex Profarmaco Milano Sr...
Manufacturer Address : 20067, Via Curiel, 34, Paullo (MI), ITALY
Registrant Name : Hyons Co., Ltd.
Registration Date : 2021-05-17
Registration Number : 20210517-210-J-993
Manufacturer Name : Syn-Tech Chem & Pharm. Co., ...
Manufacturer Address : No. 168, Kai Yuan Rd., Hsin-Ying, Tainan City 73055, Taiwan
A (-)-Epinephrine (+)-bitartrate salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Epinephrine (+)-bitartrate salt, including repackagers and relabelers. The FDA regulates (-)-Epinephrine (+)-bitartrate salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Epinephrine (+)-bitartrate salt supplier is an individual or a company that provides (-)-Epinephrine (+)-bitartrate salt active pharmaceutical ingredient (API) or (-)-Epinephrine (+)-bitartrate salt finished formulations upon request. The (-)-Epinephrine (+)-bitartrate salt suppliers may include (-)-Epinephrine (+)-bitartrate salt API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt Drug Master File in Korea ((-)-Epinephrine (+)-bitartrate salt KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (-)-Epinephrine (+)-bitartrate salt. The MFDS reviews the (-)-Epinephrine (+)-bitartrate salt KDMF as part of the drug registration process and uses the information provided in the (-)-Epinephrine (+)-bitartrate salt KDMF to evaluate the safety and efficacy of the drug.
After submitting a (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (-)-Epinephrine (+)-bitartrate salt suppliers with KDMF on PharmaCompass.
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