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 Prestwick3_000418 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000418, including repackagers and relabelers. The FDA regulates Prestwick3_000418 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000418 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Prestwick3_000418 supplier is an individual or a company that provides Prestwick3_000418 active pharmaceutical ingredient (API) or Prestwick3_000418 finished formulations upon request. The Prestwick3_000418 suppliers may include Prestwick3_000418 API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Prestwick3_000418 Drug Master File in Korea (Prestwick3_000418 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_000418. The MFDS reviews the Prestwick3_000418 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_000418 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prestwick3_000418 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 Prestwick3_000418 API can apply through the Korea Drug Master File (KDMF).
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