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
93
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A Lutavit H2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutavit H2, including repackagers and relabelers. The FDA regulates Lutavit H2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutavit H2 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 Lutavit H2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lutavit H2 supplier is an individual or a company that provides Lutavit H2 active pharmaceutical ingredient (API) or Lutavit H2 finished formulations upon request. The Lutavit H2 suppliers may include Lutavit H2 API manufacturers, exporters, distributors and traders.
click here to find a list of Lutavit H2 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 Lutavit H2 Drug Master File in Korea (Lutavit H2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lutavit H2. The MFDS reviews the Lutavit H2 KDMF as part of the drug registration process and uses the information provided in the Lutavit H2 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lutavit H2 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 Lutavit H2 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lutavit H2 suppliers with KDMF on PharmaCompass.
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