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