01 2Hetero Labs Limited(Unit-1)
02 1Jeil Pharmaceutical Co., Ltd.
03 1Pfizer Asia Manufacturing Pte. Ltd.
04 1Pfizer Cork Ltd
05 1Pfizer Ireland Pharmaceuticals
01 1CTC Bio Co., Ltd.
02 1Iksoo Pharmaceutical Co., Ltd.
03 1Jeil Pharmaceutical Co., Ltd.
04 3Korea Pfizer Pharmaceutical Co., Ltd.
01 6Sunitinib malate
01 2India
02 1South Korea
03 3U.S.A
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2021-03-17
Registration Number : Su69-9-ND
Manufacturer Name : Hetero Labs Limited(Unit-1)
Manufacturer Address : Sy.No.10, IDA,Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana ...
Registrant Name : CTC Bio Co., Ltd.
Registration Date : 2022-08-29
Registration Number : No. 69-9-ND(1)
Manufacturer Name : Hetero Labs Limited(Unit-1)
Manufacturer Address : Sy.No.10, IDA,Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana ...
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2013-08-29
Registration Number : 21-11-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (excluding...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2011-05-16
Registration Number : Su189-12-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : PO Box 140, Ringaskiddy API Plant, Ringaskiddy, Co. Cork.
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2006-05-11
Registration Number : Su189-2-ND
Manufacturer Name : Pfizer Cork Ltd
Manufacturer Address : Inchera Little Island Co. Cork, Ireland
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2015-07-29
Registration Number : Number 2582-20-ND
Manufacturer Name : Pfizer Asia Manufacturing Pt...
Manufacturer Address : 31 Tuas South Avenue 6 Singapore 637578
A Sunitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib, including repackagers and relabelers. The FDA regulates Sunitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib 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 Sunitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib supplier is an individual or a company that provides Sunitinib active pharmaceutical ingredient (API) or Sunitinib finished formulations upon request. The Sunitinib suppliers may include Sunitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib 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 Sunitinib Drug Master File in Korea (Sunitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sunitinib. The MFDS reviews the Sunitinib KDMF as part of the drug registration process and uses the information provided in the Sunitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sunitinib 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 Sunitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sunitinib suppliers with KDMF on PharmaCompass.
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