Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1Farmak, as
02 1EUROAPI FRANCE
03 1Sanofi Chimie
04 1Glenmark Life Sciences Limited
05 1ScinoPharm Taiwan, Ltd.
01 1Kukjeon Pharmaceutical Co., Ltd.
02 1M-Peak Korea Co., Ltd.
03 1SK Chemical Co., Ltd.
04 2Sanofi-Aventis Korea Co., Ltd.
01 5Riluzole
01 1Czech Republic
02 2France
03 1India
04 1Taiwan
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-12-19
Registration Number : No. 4749-12-ND
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2012-08-31
Registration Number : 3025-5-ND
Manufacturer Name : EUROAPI FRANCE
Manufacturer Address : 4 La Paterie, 63480, Vertolaye, France
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 3025-2-ND
Manufacturer Name : Sanofi Chimie
Manufacturer Address : Center de production de Vitry-sur-Seine9, Quai Jules Guesde 94403 Vitry SUR Seine Ced...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2013-05-16
Registration Number : No. 4692-8-ND
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC Industrial Estate, Ankleshwar - 393 002, Dist: Bharuch, Gujarat S...
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2021-05-14
Registration Number : No. 703-7-ND
Manufacturer Name : ScinoPharm Taiwan, Ltd.
Manufacturer Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan
A Riluzole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riluzole, including repackagers and relabelers. The FDA regulates Riluzole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riluzole 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 Riluzole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riluzole supplier is an individual or a company that provides Riluzole active pharmaceutical ingredient (API) or Riluzole finished formulations upon request. The Riluzole suppliers may include Riluzole API manufacturers, exporters, distributors and traders.
click here to find a list of Riluzole 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 Riluzole Drug Master File in Korea (Riluzole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Riluzole. The MFDS reviews the Riluzole KDMF as part of the drug registration process and uses the information provided in the Riluzole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Riluzole 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 Riluzole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Riluzole suppliers with KDMF on PharmaCompass.
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