01 1Bayer AG
02 1MSN Laboratories Private Limited
03 1Natco Pharma Limited
01 1Aging Life Science Co., Ltd.
02 1Bayer Korea Ltd.
03 1Klasia Co., Ltd.
01 2Regorafenib
02 1Regorafenib hydrate
01 1Germany
02 2India
Registrant Name : Bayer Korea Ltd.
Registration Date : 2013-05-22
Registration Number : Su2420-5-ND
Manufacturer Name : Bayer AG
Manufacturer Address : Friedrich-Ebert-Str. 217-333, 42117 Wuppertal, North Rhine-Westphalia, Germany
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-03-14
Registration Number : 434-45-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
Registrant Name : Klasia Co., Ltd.
Registration Date : 2019-05-29
Registration Number : Su758-2-ND
Manufacturer Name : Natco Pharma Limited
Manufacturer Address : Chemical Division Mekaguda Village Nandigama Mandal Rangareddy District, Telangana, I...
A Stivarga manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stivarga, including repackagers and relabelers. The FDA regulates Stivarga manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stivarga 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 Stivarga manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Stivarga supplier is an individual or a company that provides Stivarga active pharmaceutical ingredient (API) or Stivarga finished formulations upon request. The Stivarga suppliers may include Stivarga API manufacturers, exporters, distributors and traders.
click here to find a list of Stivarga 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 Stivarga Drug Master File in Korea (Stivarga KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Stivarga. The MFDS reviews the Stivarga KDMF as part of the drug registration process and uses the information provided in the Stivarga KDMF to evaluate the safety and efficacy of the drug.
After submitting a Stivarga 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 Stivarga API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Stivarga suppliers with KDMF on PharmaCompass.
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