01 1Huvepharma Italia Srl
02 1MSN Laboratories Private Limited
01 2Sanofi-Aventis Korea Co., Ltd.
01 2Vigabatrin
01 1India
02 1Italy
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2022-11-08
Registration Number : 20221108-209-J-1400
Manufacturer Name : Huvepharma Italia Srl
Manufacturer Address : Via R. Lepetit, 142 12075 - GARESIO (CN)
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2023-11-15
Registration Number : 20231115-209-J-1564
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : Sy. No. 317 & 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal),...
A Vigabatrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vigabatrin, including repackagers and relabelers. The FDA regulates Vigabatrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vigabatrin 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 Vigabatrin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vigabatrin supplier is an individual or a company that provides Vigabatrin active pharmaceutical ingredient (API) or Vigabatrin finished formulations upon request. The Vigabatrin suppliers may include Vigabatrin API manufacturers, exporters, distributors and traders.
click here to find a list of Vigabatrin 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 Vigabatrin Drug Master File in Korea (Vigabatrin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vigabatrin. The MFDS reviews the Vigabatrin KDMF as part of the drug registration process and uses the information provided in the Vigabatrin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vigabatrin 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 Vigabatrin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vigabatrin suppliers with KDMF on PharmaCompass.
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