01 1Grunenthal GmbH
02 1Janssen Pharmaceuticals, Inc. @[Some Process Manufacturer] Janssen Pharmaceutica NV
01 2Korea Janssen Co., Ltd.
01 2Tapentadol hydrochloride
01 1Germany
02 1U.S.A
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2015-11-11
Registration Number : No. 4945-23-ND
Manufacturer Name : Grunenthal GmbH
Manufacturer Address : Zieglerstrabe 6, 52078 Aachen, Germany
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2014-07-03
Registration Number : No. 4945-19-ND
Manufacturer Name : Janssen Pharmaceuticals, Inc...
Manufacturer Address : 1440 Olympic Drive, Athens, Georgia (GA) 30601, USA@Janssen Pharmaceuticalaan 3, Geel...
A Tapentadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tapentadol, including repackagers and relabelers. The FDA regulates Tapentadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tapentadol 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 Tapentadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tapentadol supplier is an individual or a company that provides Tapentadol active pharmaceutical ingredient (API) or Tapentadol finished formulations upon request. The Tapentadol suppliers may include Tapentadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tapentadol 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 Tapentadol Drug Master File in Korea (Tapentadol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tapentadol. The MFDS reviews the Tapentadol KDMF as part of the drug registration process and uses the information provided in the Tapentadol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tapentadol 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 Tapentadol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tapentadol suppliers with KDMF on PharmaCompass.
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