01 1FIS Fabbrica Italiana Sintetici SpA
02 1Kashima Plant of Eisai Co., Ltd.
03 1MSN Organics Private Limited
01 1Aging Life Science Co., Ltd.
02 2Korea Ezai Co., Ltd.
01 3Perampanel
01 1India
02 1Italy
03 1Japan
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2015-03-27
Registration Number : Su3834-4-ND
Manufacturer Name : Kashima Plant of Eisai Co., ...
Manufacturer Address : 22 Sunayama, Kamisu-shi, Ibaraki-ken, Japan
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2020-06-25
Registration Number : Su140-7-ND
Manufacturer Name : FIS Fabbrica Italiana Sintet...
Manufacturer Address : Viale Milano, 26 - 36075 Montecchio Maggiore (Vicenza) Italy
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 434-31-ND
Manufacturer Name : MSN Organics Private Limited
Manufacturer Address : Sy.No.224/A, Bibinagar (Village), Bihinagar (Mandal), Yadadri Bhuvanagiri District, T...
A Fycompa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fycompa, including repackagers and relabelers. The FDA regulates Fycompa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fycompa 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 Fycompa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fycompa supplier is an individual or a company that provides Fycompa active pharmaceutical ingredient (API) or Fycompa finished formulations upon request. The Fycompa suppliers may include Fycompa API manufacturers, exporters, distributors and traders.
click here to find a list of Fycompa 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 Fycompa Drug Master File in Korea (Fycompa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fycompa. The MFDS reviews the Fycompa KDMF as part of the drug registration process and uses the information provided in the Fycompa KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fycompa 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 Fycompa API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fycompa suppliers with KDMF on PharmaCompass.
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