01 1BrightGene Fine Chemical Co., Ltd.
01 1Otran Korea Co., Ltd.
01 1Pimecrolimus
01 1China
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-07-30
Registration Number : 20250730-211-J-1953
Manufacturer Name : BrightGene Fine Chemical Co....
Manufacturer Address : No. 10 Tongyuan Road, Taixing Economic Development Zone, Taizhou, Jiangsu 225400, Chi...
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A Elidel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elidel, including repackagers and relabelers. The FDA regulates Elidel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elidel 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 Elidel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Elidel supplier is an individual or a company that provides Elidel active pharmaceutical ingredient (API) or Elidel finished formulations upon request. The Elidel suppliers may include Elidel API manufacturers, exporters, distributors and traders.
click here to find a list of Elidel 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 Elidel Drug Master File in Korea (Elidel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Elidel. The MFDS reviews the Elidel KDMF as part of the drug registration process and uses the information provided in the Elidel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Elidel 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 Elidel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Elidel suppliers with KDMF on PharmaCompass.
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