01 1Bayer AG@Bayer AG
02 1Cipla Limited
03 2Hetero Labs Limited
04 1Jeil Pharmaceutical Co., Ltd.
05 1Natco Pharma Limited
06 1Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.
07 1Shandong Anhong Pharmaceutical Co., Ltd
01 1Aging Life Science Co., Ltd.
02 1Bayer Korea Ltd.
03 1Hanmi Pharmaceutical Co., Ltd.
04 1Jeil Pharmaceutical Co., Ltd.
05 1M-Peak Korea Co., Ltd.
06 1Sampoong Pharmachem Co., Ltd.
07 1Sungwoo Chemical Co., Ltd.
08 1UNUST Co., Ltd.
01 1Micronized sorafenib tosylate
02 7Sorafenib tosylate
01 2China
02 1Germany
03 4India
04 1South Korea
Registrant Name : Bayer Korea Ltd.
Registration Date : 2007-12-28
Registration Number : Su2420-1-ND
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Friedrich-Ebert-Str.217-333, 42117,Wuppertal,Germany_x000D_ @51368 leverkusen
Registrant Name : UNUST Co., Ltd.
Registration Date : 2012-07-13
Registration Number : No. 4838-16-ND
Manufacturer Name : Cipla Limited
Manufacturer Address : Plot No. 285, 286 & 287 KIADB, IV PHASE, Jigani - Bommasandra Link Road, Bommasandra,...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2018-02-08
Registration Number : No. 473-19-ND(1)
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Unit-Ⅰ, Sy.No. 10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2017-12-04
Registration Number : 473-19-ND
Manufacturer Name : Hetero Labs Limited
Manufacturer Address : Unit-Ⅰ, Sy.No. 10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District...
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2014-11-24
Registration Number : 1668-15-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong an...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-04-06
Registration Number : 434-32-ND
Manufacturer Name : Natco Pharma Limited
Manufacturer Address : Chemical Division Mekaguda Village, Nandigama Mandal Rangareddy District Telangana, 5...
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2016-04-19
Registration Number : No. 5643-3-ND(1)
Manufacturer Name : Qilu Antibiotics (Linyi) Pha...
Manufacturer Address : 251500 North of Huayuan Road(W), Linyi County, Shandong, PR China
Registrant Name : Sampoong Pharmachem Co., Ltd.
Registration Date : 2016-03-07
Registration Number : No. 5643-3-ND
Manufacturer Name : Shandong Anhong Pharmaceutic...
Manufacturer Address : No. 29 Huayuan Street, Linyi County, Dezhou, Shandong, China
A Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexavar, including repackagers and relabelers. The FDA regulates Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexavar 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 Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexavar supplier is an individual or a company that provides Nexavar active pharmaceutical ingredient (API) or Nexavar finished formulations upon request. The Nexavar suppliers may include Nexavar API manufacturers, exporters, distributors and traders.
click here to find a list of Nexavar 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 Nexavar Drug Master File in Korea (Nexavar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexavar. The MFDS reviews the Nexavar KDMF as part of the drug registration process and uses the information provided in the Nexavar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nexavar 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 Nexavar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nexavar suppliers with KDMF on PharmaCompass.
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