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