01 1ROQUETTE FRERES
01 1Rocket Korea Co., Ltd.
01 1Icodextrin
01 1France
Registrant Name : Rocket Korea Co., Ltd.
Registration Date : 2024-08-28
Registration Number : 20240828-211-J-1682
Manufacturer Name : ROQUETTE FRERES
Manufacturer Address : 1 Rue de la Haute Loge, 62136 LESTREM, France
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A Extraneal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Extraneal, including repackagers and relabelers. The FDA regulates Extraneal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Extraneal 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 Extraneal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Extraneal supplier is an individual or a company that provides Extraneal active pharmaceutical ingredient (API) or Extraneal finished formulations upon request. The Extraneal suppliers may include Extraneal API manufacturers, exporters, distributors and traders.
click here to find a list of Extraneal 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 Extraneal Drug Master File in Korea (Extraneal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Extraneal. The MFDS reviews the Extraneal KDMF as part of the drug registration process and uses the information provided in the Extraneal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Extraneal 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 Extraneal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Extraneal suppliers with KDMF on PharmaCompass.
