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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vonoprazan, including repackagers and relabelers. The FDA regulates Vonoprazan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vonoprazan 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vonoprazan supplier is an individual or a company that provides Vonoprazan active pharmaceutical ingredient (API) or Vonoprazan finished formulations upon request. The Vonoprazan suppliers may include Vonoprazan API manufacturers, exporters, distributors and traders.
click here to find a list of Vonoprazan 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 Drug Master File in Korea (Vonoprazan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vonoprazan. The MFDS reviews the Vonoprazan KDMF as part of the drug registration process and uses the information provided in the Vonoprazan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vonoprazan 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vonoprazan suppliers with KDMF on PharmaCompass.
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