01 1BrightGene Fine Chemical Co., Ltd.
01 1Otran Korea Co., Ltd.
01 1Carboxymaltose ferric hydroxide complex salt
01 1China
Carboxymaltose ferric hydroxide complex salt
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2024-02-29
Registration Number : 20240229-211-J-1614
Manufacturer Name : BrightGene Fine Chemical Co....
Manufacturer Address : No. 10 Tongyuan Road, Taixing Economic Development Zone, Taizhou, Jiangsu 225400, Chi...
A Ferric Carboxymaltose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Carboxymaltose, including repackagers and relabelers. The FDA regulates Ferric Carboxymaltose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Carboxymaltose 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 Ferric Carboxymaltose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ferric Carboxymaltose supplier is an individual or a company that provides Ferric Carboxymaltose active pharmaceutical ingredient (API) or Ferric Carboxymaltose finished formulations upon request. The Ferric Carboxymaltose suppliers may include Ferric Carboxymaltose API manufacturers, exporters, distributors and traders.
click here to find a list of Ferric Carboxymaltose 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 Ferric Carboxymaltose Drug Master File in Korea (Ferric Carboxymaltose KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ferric Carboxymaltose. The MFDS reviews the Ferric Carboxymaltose KDMF as part of the drug registration process and uses the information provided in the Ferric Carboxymaltose KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ferric Carboxymaltose 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 Ferric Carboxymaltose API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ferric Carboxymaltose suppliers with KDMF on PharmaCompass.
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