01 1Korea Biochem Pharmaceutical Co., Ltd.
01 1Korea Biochem Pharmaceutical Co., Ltd.
01 1Indigo carmine
01 1South Korea
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2021-10-29
Registration Number : 20211029-211-J-1133
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : 204 Sandan-gil, Jeonui-myeon, Sejong Special Self-Governing City
A Indigo Carmine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indigo Carmine, including repackagers and relabelers. The FDA regulates Indigo Carmine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indigo Carmine 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 Indigo Carmine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indigo Carmine supplier is an individual or a company that provides Indigo Carmine active pharmaceutical ingredient (API) or Indigo Carmine finished formulations upon request. The Indigo Carmine suppliers may include Indigo Carmine API manufacturers, exporters, distributors and traders.
click here to find a list of Indigo Carmine 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 Indigo Carmine Drug Master File in Korea (Indigo Carmine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indigo Carmine. The MFDS reviews the Indigo Carmine KDMF as part of the drug registration process and uses the information provided in the Indigo Carmine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indigo Carmine 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 Indigo Carmine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Indigo Carmine suppliers with KDMF on PharmaCompass.
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