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