01 1MSD International GmbH
01 1Korea MSD Co., Ltd.
01 1Boceprevir
01 1U.S.A
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2014-06-24
Registration Number : Su3281-14-ND
Manufacturer Name : MSD International GmbH
Manufacturer Address : 50 Tuas West Drive Singapore 638408
A Boceprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boceprevir, including repackagers and relabelers. The FDA regulates Boceprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boceprevir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Boceprevir supplier is an individual or a company that provides Boceprevir active pharmaceutical ingredient (API) or Boceprevir finished formulations upon request. The Boceprevir suppliers may include Boceprevir API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Boceprevir Drug Master File in Korea (Boceprevir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Boceprevir. The MFDS reviews the Boceprevir KDMF as part of the drug registration process and uses the information provided in the Boceprevir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Boceprevir 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 Boceprevir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Boceprevir suppliers with KDMF on PharmaCompass.
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