01 1H.L.G.Nomics Co., Ltd.
02 1Korea Biochem Pharmaceutical Co., Ltd.
03 1SPC Co., Ltd.
01 1H.L.G.Nomics Co., Ltd.
02 1Korea Biochem Pharmaceutical Co., Ltd.
03 1SPC Co., Ltd.
01 3Bonoprazan fumarate
01 3South Korea
Registrant Name : H.L.G.Nomics Co., Ltd.
Registration Date : 2024-04-17
Registration Number : 94-10-ND
Manufacturer Name : H.L.G.Nomics Co., Ltd.
Manufacturer Address : 1552 Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2023-12-13
Registration Number : 2152-21-ND
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : Korea Biochem Pharmaceutical Co., Ltd. 204 Sandan-gil, Jeonui-myeon, Sejong Special S...
Registrant Name : SPC Co., Ltd.
Registration Date : 2023-05-26
Registration Number : 2551-3-ND
Manufacturer Name : SPC Co., Ltd.
Manufacturer Address : 386 Pyeongtaek Port Road, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
A Vonoprazan Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan Fumarate, including repackagers and relabelers. The FDA regulates Vonoprazan Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan Fumarate 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 Vonoprazan Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan Fumarate supplier is an individual or a company that provides Vonoprazan Fumarate active pharmaceutical ingredient (API) or Vonoprazan Fumarate finished formulations upon request. The Vonoprazan Fumarate suppliers may include Vonoprazan Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan Fumarate 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 Vonoprazan Fumarate Drug Master File in Korea (Vonoprazan Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan Fumarate. The MFDS reviews the Vonoprazan Fumarate KDMF as part of the drug registration process and uses the information provided in the Vonoprazan Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan Fumarate 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 Vonoprazan Fumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vonoprazan Fumarate suppliers with KDMF on PharmaCompass.
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