01 1Zhejiang Shengda Bio-Pharm Co., Ltd.
01 1Otran Korea Co., Ltd.
01 1biotin
01 1China
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-211-J-1124
Manufacturer Name : Zhejiang Shengda Bio-Pharm C...
Manufacturer Address : No.789, Renmin East Road, Tiantai, Zhejiang, China, 317200
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A Gabunat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabunat, including repackagers and relabelers. The FDA regulates Gabunat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabunat 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 Gabunat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gabunat supplier is an individual or a company that provides Gabunat active pharmaceutical ingredient (API) or Gabunat finished formulations upon request. The Gabunat suppliers may include Gabunat API manufacturers, exporters, distributors and traders.
click here to find a list of Gabunat 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 Gabunat Drug Master File in Korea (Gabunat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gabunat. The MFDS reviews the Gabunat KDMF as part of the drug registration process and uses the information provided in the Gabunat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gabunat 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 Gabunat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gabunat suppliers with KDMF on PharmaCompass.
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