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