01 1Excella GmbH & Co. KG
01 1Korea Pfizer Pharmaceutical Co., Ltd.
01 1Talazopariptosylate
01 1Germany
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2020-07-29
Registration Number : 87-28-ND
Manufacturer Name : Excella GmbH & Co. KG
Manufacturer Address : Nürnberger Strasse 12, 90537 Feucht, Germany
A Talazoparib Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Talazoparib Tosylate, including repackagers and relabelers. The FDA regulates Talazoparib Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Talazoparib Tosylate 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 Talazoparib Tosylate supplier is an individual or a company that provides Talazoparib Tosylate active pharmaceutical ingredient (API) or Talazoparib Tosylate finished formulations upon request. The Talazoparib Tosylate suppliers may include Talazoparib Tosylate 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 Talazoparib Tosylate Drug Master File in Korea (Talazoparib Tosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Talazoparib Tosylate. The MFDS reviews the Talazoparib Tosylate KDMF as part of the drug registration process and uses the information provided in the Talazoparib Tosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Talazoparib Tosylate 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 Talazoparib Tosylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Talazoparib Tosylate suppliers with KDMF on PharmaCompass.
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