01 2BrightGene Pharmaceutical Co. Ltd.
01 1Kyungbo Pharmaceutical Co., Ltd.
02 1Otran Korea Co., Ltd.
01 1Entecavir hydrate
02 1Entecavir monohydrate (micronized)
01 1China
02 1South Korea
Entecavir monohydrate (micronized)
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2022-05-30
Registration Number : Su695-7-ND
Manufacturer Name : BrightGene Pharmaceutical Co...
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, 215123...
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2019-10-30
Registration Number : 1673-31-ND
Manufacturer Name : BrightGene Pharmaceutical Co...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do, Building C25-C28, No.218 Xinghu Road, Suzho...
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PharmaCompass offers a list of Entecavir Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Entecavir Monohydrate manufacturer or Entecavir Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Entecavir Monohydrate manufacturer or Entecavir Monohydrate supplier.
A Entecavir Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entecavir Monohydrate, including repackagers and relabelers. The FDA regulates Entecavir Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entecavir Monohydrate 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 Entecavir Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Entecavir Monohydrate supplier is an individual or a company that provides Entecavir Monohydrate active pharmaceutical ingredient (API) or Entecavir Monohydrate finished formulations upon request. The Entecavir Monohydrate suppliers may include Entecavir Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Entecavir Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Entecavir Monohydrate Drug Master File in Korea (Entecavir Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Entecavir Monohydrate. The MFDS reviews the Entecavir Monohydrate KDMF as part of the drug registration process and uses the information provided in the Entecavir Monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Entecavir Monohydrate 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 Entecavir Monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Entecavir Monohydrate suppliers with KDMF on PharmaCompass.
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