01 1SK Biotek Ireland Limited
01 1Korea BMS Pharmaceutical Co., Ltd.
01 1Atazanavir sulfate
01 1U.S.A
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2009-08-21
Registration Number : Su335-4-ND
Manufacturer Name : SK Biotek Ireland Limited
Manufacturer Address : Watery Lane, Swords, County Dublin
74
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A N349 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N349, including repackagers and relabelers. The FDA regulates N349 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N349 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 N349 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A N349 supplier is an individual or a company that provides N349 active pharmaceutical ingredient (API) or N349 finished formulations upon request. The N349 suppliers may include N349 API manufacturers, exporters, distributors and traders.
click here to find a list of N349 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 N349 Drug Master File in Korea (N349 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of N349. The MFDS reviews the N349 KDMF as part of the drug registration process and uses the information provided in the N349 KDMF to evaluate the safety and efficacy of the drug.
After submitting a N349 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 N349 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of N349 suppliers with KDMF on PharmaCompass.
