01 1Roquette Freres
01 1Rocket Korea Ltd.
01 1Glucose monohydrate
01 1France
Registrant Name : Rocket Korea Ltd.
Registration Date : 2024-12-23
Registration Number : 20241223-211-J-1734
Manufacturer Name : Roquette Freres
Manufacturer Address : 1 Rue de la Haute Loge, 62136 LESTREM, France
A Dextrose Monohydrate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextrose Monohydrate API, including repackagers and relabelers. The FDA regulates Dextrose Monohydrate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextrose Monohydrate API 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 Dextrose Monohydrate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextrose Monohydrate API supplier is an individual or a company that provides Dextrose Monohydrate API active pharmaceutical ingredient (API) or Dextrose Monohydrate API finished formulations upon request. The Dextrose Monohydrate API suppliers may include Dextrose Monohydrate API API manufacturers, exporters, distributors and traders.
click here to find a list of Dextrose Monohydrate API 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 Dextrose Monohydrate API Drug Master File in Korea (Dextrose Monohydrate API KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dextrose Monohydrate API. The MFDS reviews the Dextrose Monohydrate API KDMF as part of the drug registration process and uses the information provided in the Dextrose Monohydrate API KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dextrose Monohydrate API 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 Dextrose Monohydrate API API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dextrose Monohydrate API suppliers with KDMF on PharmaCompass.
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