01 1Merck KGaA
02 1Optimus Drugs Private Limited
03 1Solara Active Pharma Sciences Limited
01 1Aging Life Science Co., Ltd.
02 1Korea Ezai Co., Ltd.
03 1Saehan Pharmaceutical Co., Ltd.
01 3Safinamide mesylate
01 1Germany
02 2India
Registrant Name : Korea Ezai Co., Ltd.
Registration Date : 2020-06-24
Registration Number : Su140-6-ND
Manufacturer Name : Merck KGaA
Manufacturer Address : Frankfurter Straße 250 D-64293 Darmstadt, Germany
Registrant Name : Saehan Pharmaceutical Co., Ltd.
Registration Date : 2022-05-27
Registration Number : Su532-8-ND
Manufacturer Name : Optimus Drugs Private Limite...
Manufacturer Address : Sy. No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri Distri...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-03-03
Registration Number : 434-52-ND
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, Sipcot Industrial Complex, Kudikadu Village Cuddalore-607 005, Tamil Nadu, Indi...
A Safinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide, including repackagers and relabelers. The FDA regulates Safinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide 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 Safinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Safinamide supplier is an individual or a company that provides Safinamide active pharmaceutical ingredient (API) or Safinamide finished formulations upon request. The Safinamide suppliers may include Safinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Safinamide 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 Safinamide Drug Master File in Korea (Safinamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Safinamide. The MFDS reviews the Safinamide KDMF as part of the drug registration process and uses the information provided in the Safinamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Safinamide 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 Safinamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Safinamide suppliers with KDMF on PharmaCompass.
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