01 1Acebright (India) Pharma Private Limited
02 2Cdymax (India) Pharma Private Limited
03 3Cipla Limited
04 1Cipla Limited.
05 1Estifarm Co., Ltd._x000D_
06 1FIS FABBRICA ITALIANA SINTETICI SPA@FIS FABBRICA ITALIANA SINTETICI SPA
07 1Hetero Labs Limited(Unit-I)
08 1Intas Pharmaceuticals Limited
09 1Jari Pharmaceutical Co., Ltd.
10 1Jeil Pharmaceutical Co., Ltd.
11 1Kyungbo Pharmaceutical Co., Ltd.
12 1Lee Yeon Pharmaceutical Co., Ltd.
13 1Mac-Chem Products (India) Pvt.Ltd.
14 4Natco Pharma Limited
15 3Nosch Labs Pvt. Ltd
16 1PLIVA Croatia Ltd.
17 1Qilu Tianhe Pharmaceutical
18 1SUN PHARMACEUTICAL INDUSTRIES LTD.
19 1Shilpa Medicare Limited
20 1Shilpa Pharma Lifesciences Limited
21 1Shin Poong Pharmaceutical Co., Ltd.
22 1Sterling Pharma Ringaskiddy Limited@[sieving process manufacturing plant]Novartis Pharma Stein AG
23 1Suven Life Sciences Ltd
01 1Alvogen Korea Co., Ltd.
02 1Boryeong Co., Ltd.
03 1Chong Kun Dang Co., Ltd.
04 1Dasan Pharmaceutical Co., Ltd.
05 1Estifarm Co., Ltd.
06 1HKINNOEN Co., Ltd.
07 1Hyundai Bioland Co., Ltd.
08 1Ildong Pharmaceutical Co., Ltd.
09 1Jeil Pharmaceutical Co., Ltd.
10 1Klasia Co., Ltd.
11 1Korea United Pharmaceutical Co., Ltd.
12 1Kukjeon Pharmaceutical Co., Ltd.
13 2Kyungbo Pharmaceutical Co., Ltd.
14 1Lee Yeon Pharmaceutical Co., Ltd.
15 1Masung LS Co., Ltd.
16 2Novartis Korea Ltd.
17 2Samoh Pharmaceutical Co., Ltd.
18 1Sampoong Pharmachem Co., Ltd.
19 1Seongi Bio Co., Ltd.
20 1Shin Poong Pharmaceutical Co., Ltd.
21 2Sungwoo Chemical Co., Ltd.
22 2Toru Corporation
23 1UN U-Generic Co., Ltd.
24 1UNUST Co., Ltd.
25 1Wonpung Pharmaceutical Co., Ltd.
26 1Yuhan Corporation
01 28Imatinib mesylate
02 3Mesilic acid imatinib
01 1China
02 1Croatia
03 21India
04 1Italy
05 5South Korea
06 1United Kingdom
07 1Blank
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2019-06-27
Registration Number : Su522-2-ND
Manufacturer Name : Acebright (India) Pharma Pri...
Manufacturer Address : #116/117, KIADB Industrial Area, Jigani, Anekal, Taluk, Bangalore-560105, India
Registrant Name : Toru Corporation
Registration Date : 2024-11-18
Registration Number : Su651-5-ND
Manufacturer Name : Cdymax (India) Pharma Privat...
Manufacturer Address : No. 116/117, KIADB Industrial Area, Jigani, 2nd Phase, Bangalore-560 105, Karnataka, ...
Registrant Name : Toru Corporation
Registration Date : 2023-02-16
Registration Number : No. 522-2-ND(A)
Manufacturer Name : Cdymax (India) Pharma Privat...
Manufacturer Address : #116/117, KIADB Industrial Area, Jigani, Anekal, Taluk, Bangalore-560105, India
Registrant Name : Novartis Korea Ltd.
Registration Date : 2022-10-18
Registration Number : 196-24-ND
Manufacturer Name : FIS FABBRICA ITALIANA SINTET...
Manufacturer Address : Via Massimo D'Antona, 13, 86039 Termoli Campobasso, Italy@Viale Milano, 26, 36075 Mon...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2019-09-02
Registration Number : 473-23-ND
Manufacturer Name : Hetero Labs Limited(Unit-I)
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telan...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-04-08
Registration Number : 207-54-ND
Manufacturer Name : Intas Pharmaceuticals Limite...
Manufacturer Address : Plot No. 457 & 458, Village Matoda, Bavla road and Plot No. 191/218 P, Village Chacha...
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-06-23
Registration Number : 1673-35-ND
Manufacturer Name : Jari Pharmaceutical Co., Ltd...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @No. 18 Zhenhua Road, Lianyungang, China
Registrant Name : Hyundai Bioland Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 22-5-ND(B)
Manufacturer Name : Natco Pharma Limited
Manufacturer Address : Chemical Division, Mekaguda Village, Nandigama Mandal, Rangareddy District, Telagana ...
Registrant Name : Klasia Co., Ltd.
Registration Date : 2020-01-08
Registration Number : 22-5-ND(A)
Manufacturer Name : Natco Pharma Limited
Manufacturer Address : Chemical Division Mekaguda Village Nandigama Mandal Rangareddy District, Telangana, I...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2017-08-03
Registration Number : No. 3838-5-ND(2)
Manufacturer Name : Nosch Labs Pvt. Ltd
Manufacturer Address : Sy.No.14, Gaddapotharam (Village), IDA, Kazipally, Jinnaram (Mandal), Medak District,...
A Gleevec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gleevec, including repackagers and relabelers. The FDA regulates Gleevec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gleevec 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 Gleevec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gleevec supplier is an individual or a company that provides Gleevec active pharmaceutical ingredient (API) or Gleevec finished formulations upon request. The Gleevec suppliers may include Gleevec API manufacturers, exporters, distributors and traders.
click here to find a list of Gleevec 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 Gleevec Drug Master File in Korea (Gleevec KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gleevec. The MFDS reviews the Gleevec KDMF as part of the drug registration process and uses the information provided in the Gleevec KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gleevec 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 Gleevec API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gleevec suppliers with KDMF on PharmaCompass.
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