01 1BrightGene Pharmaceutical Co. Ltd
02 1Mitsubishi Tanabe Pharma Factory Ltd., Onoda Plant
01 1Hwail Pharmaceutical Co., Ltd.
02 1Mitsubishi Tanabe Pharma Korea Co., Ltd.
01 2Agatroban hydrate
01 1Japan
02 1South Korea
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20200714-210-J-587
Manufacturer Name : BrightGene Pharmaceutical Co...
Manufacturer Address : 57, Yakjeonggongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @Building C25-C28, ...
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2022-01-21
Registration Number : 20220121-210-J-1219
Manufacturer Name : Mitsubishi Tanabe Pharma Fac...
Manufacturer Address : 7473-2, Ooaza Onoda, SanyoOnoda,Yamaguchi, 756-0054, Japan
A Argatroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban, including repackagers and relabelers. The FDA regulates Argatroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban 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 Argatroban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban supplier is an individual or a company that provides Argatroban active pharmaceutical ingredient (API) or Argatroban finished formulations upon request. The Argatroban suppliers may include Argatroban API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban 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 Argatroban Drug Master File in Korea (Argatroban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Argatroban. The MFDS reviews the Argatroban KDMF as part of the drug registration process and uses the information provided in the Argatroban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Argatroban 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 Argatroban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Argatroban suppliers with KDMF on PharmaCompass.
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