01 1Lonza AG@[Manufacturer of Micronized Process] Jetpharma SA@[Manufacturer of Micronized Process] Micro-Macinazione SA
01 1Korea Janssen Co., Ltd.
01 1Masitentan
01 1Switzerland
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2014-06-23
Registration Number : Su4722-4-ND
Manufacturer Name : Lonza AG@[Manufacturer of Mi...
Manufacturer Address : Lonzastrasse, 3930 Visp, Switzerland@Via Sottobisio 42 A, 6828 Balerna, Switzerland@V...
A Macitentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macitentan, including repackagers and relabelers. The FDA regulates Macitentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macitentan 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 Macitentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macitentan supplier is an individual or a company that provides Macitentan active pharmaceutical ingredient (API) or Macitentan finished formulations upon request. The Macitentan suppliers may include Macitentan API manufacturers, exporters, distributors and traders.
click here to find a list of Macitentan 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 Macitentan Drug Master File in Korea (Macitentan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Macitentan. The MFDS reviews the Macitentan KDMF as part of the drug registration process and uses the information provided in the Macitentan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Macitentan 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 Macitentan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Macitentan suppliers with KDMF on PharmaCompass.
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