01 1Grunenthal GmbH
01 1BC World Pharmaceutical Co., Ltd.
01 1tapentadol hydrochloride
01 1Germany
Registrant Name : BC World Pharmaceutical Co., Ltd.
Registration Date : 2015-11-11
Registration Number : Su4945-23-ND
Manufacturer Name : Grunenthal GmbH
Manufacturer Address : Zieglerstrabe 6, 52078 Aachen, Germany
90
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A Palexia SR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Palexia SR, including repackagers and relabelers. The FDA regulates Palexia SR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Palexia SR API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Palexia SR supplier is an individual or a company that provides Palexia SR active pharmaceutical ingredient (API) or Palexia SR finished formulations upon request. The Palexia SR suppliers may include Palexia SR API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Palexia SR Drug Master File in Korea (Palexia SR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Palexia SR. The MFDS reviews the Palexia SR KDMF as part of the drug registration process and uses the information provided in the Palexia SR KDMF to evaluate the safety and efficacy of the drug.
After submitting a Palexia SR 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 Palexia SR API can apply through the Korea Drug Master File (KDMF).
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