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List of Drug Master Files (KDMF) for Imatinib Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Acebright (India) Pharma Private Limited (1)

02 Cdymax (India) Pharma Private Limited (1)

03 Cipla Limited (3)

04 Cipla Limited. (1)

05 FIS FABBRICA ITALIANA SINTETICI SPA@FIS FABBRICA ITALIANA SINTETICI SPA (1)

06 Hetero Labs Limited (Unit-I) (1)

07 Intas Pharmaceuticals Limited (1)

08 Jeil Pharmaceutical Co., Ltd. (1)

09 Kyeong Pharmaceutical Co., Ltd. (1)

10 Kyungbo Pharmaceutical Co., Ltd.@Jari Pharmaceutical Co., Ltd. (1)

11 Leeyeon Pharmaceutical Co., Ltd. (1)

12 Mac-Chem Products (India) Pvt.Ltd. (1)

13 Natco Pharma Limited (4)

14 Nosch Labs Pvt. Ltd (3)

15 PLIVA Croatia Ltd. (1)

16 Qilu Tianhe Pharmaceutical (1)

17 ST Pharm Co., Ltd._x000D_ (1)

18 SUN PHARMACEUTICAL INDUSTRIES LTD. (1)

19 Samhwa Biopharm Co., Ltd. (1)

20 Shilpa Medicare Limited (1)

21 Shilpa Pharma Lifesciences Limited (1)

22 Shinpoong Pharmaceutical Co., Ltd. (1)

23 Sterling Pharma Ringaskiddy Limited@[sieving process manufactory]Novartis Pharma Stein AG (1)

24 Suven Life Sciences Ltd (1)

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01 Alvogen Korea Co., Ltd. (1)

02 Boryeong Co., Ltd. (1)

03 Chong Kun Dang Co., Ltd. (1)

04 Classia Co., Ltd. (1)

05 Dasan Pharmaceutical Co., Ltd. (1)

06 HK Innoen Co., Ltd. (1)

07 Hyundai Bioland Co., Ltd. (1)

08 Ildong Pharmaceutical Co., Ltd. (1)

09 Jeil Pharmaceutical Co., Ltd. (1)

10 Kookjeon Pharmaceutical Co., Ltd. (1)

11 Korea United Pharmaceutical Co., Ltd. (1)

12 Kyungbo Pharmaceutical Co., Ltd. (2)

13 Leeyeon Pharmaceutical Co., Ltd. (1)

14 Masung LS Co., Ltd. (1)

15 Novartis Korea Co., Ltd. (2)

16 ST Pharm Co., Ltd. (1)

17 Samhwa Biopharm Co., Ltd. (1)

18 Samo Pharmaceutical Co., Ltd. (2)

19 Sampoong Pharmachem Co., Ltd. (1)

20 Seongui Bio Co., Ltd. (1)

21 Shinpoong Pharmaceutical Co., Ltd. (1)

22 Sungwoo Chemical Co., Ltd. (2)

23 Toru Co., Ltd. (1)

24 UN Generic Co., Ltd. (1)

25 UNUST Co., Ltd. (1)

26 Wonpoong Pharmaceutical Co., Ltd. (1)

27 Yuhan Corporation (1)

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01 Imatinib Mesylate (27)

02 Imatinib mesylate (4)

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01 China (1)

02 Croatia (1)

03 India (20)

04 Italy (1)

05 South Korea (6)

06 Switzerland (1)

07 Blank (1)

URL Supplier Web Content
Alvogen Korea Co., Ltd.
2019-06-27
Number 522-2-ND
Acebright (India) Pharma ...
India
#116/117, KIADB Industria...
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Toru Co., Ltd.
2023-02-16
Number 522-2-ND(A)
Cdymax (India) Pharma Pri...
India
#116/117, KIADB Industria...
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Novartis Korea Co., Ltd.
2022-10-18
Wed196-24-ND
FIS FABBRICA ITALIANA SIN...
Italy
Via Massimo D'Antona, 13,...
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Sungwoo Chemical Co., Ltd.
2019-09-02
Number 473-23-ND
Hetero Labs Limited (Unit...
India
Survey No.10, IDA, Gaddap...
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Samo Pharmaceutical Co., Ltd.
2022-04-08
Wed207-54-ND
Intas Pharmaceuticals Lim...
India
Plot No. 457 & 458, Villa...
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Kyungbo Pharmaceutical Co., Ltd.
2020-06-23
1673-35-ND
Kyungbo Pharmaceutical Co...
South Korea
174 Silok-ro, Asan-si, Ch...
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Hyundai Bioland Co., Ltd.
2022-08-04
22-5-ND(B)
Natco Pharma Limited
India
Chemical Division, Mekagu...
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Classia Co., Ltd.
2020-01-08
22-5-ND(A)
Natco Pharma Limited
India
Chemical Division Mekagud...
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Sungwoo Chemical Co., Ltd.
2017-08-03
Number 3838-5-ND(2)
Nosch Labs Pvt. Ltd
India
Sy.No.14, Gaddapotharam (...
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Sampoong Pharmachem Co., Ltd.
2016-04-05
Number 5643-4-ND
Qilu Tianhe Pharmaceutica...
China
No. 849 Dongjia Town, Lic...
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Looking for 220127-57-1 / Imatinib Mesylate API manufacturers, exporters & distributors?

Imatinib Mesylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Imatinib Mesylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Imatinib Mesylate manufacturer or Imatinib Mesylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Imatinib Mesylate manufacturer or Imatinib Mesylate supplier.

PharmaCompass also assists you with knowing the Imatinib Mesylate API Price utilized in the formulation of products. Imatinib Mesylate API Price is not always fixed or binding as the Imatinib Mesylate Price is obtained through a variety of data sources. The Imatinib Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Imatinib Mesylate

Synonyms

220127-57-1, Gleevec, Glivec, Imatinib mesilate, Sti-571, Imatinib methanesulfonate

Cas Number

220127-57-1

Unique Ingredient Identifier (UNII)

8A1O1M485B

About Imatinib Mesylate

A tyrosine kinase inhibitor and ANTINEOPLASTIC AGENT that inhibits the BCR-ABL kinase created by chromosome rearrangements in CHRONIC MYELOID LEUKEMIA and ACUTE LYMPHOBLASTIC LEUKEMIA, as well as PDG-derived tyrosine kinases that are overexpressed in gastrointestinal stromal tumors.

Imatinib Manufacturers

A Imatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imatinib, including repackagers and relabelers. The FDA regulates Imatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imatinib 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 Imatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Imatinib Suppliers

A Imatinib supplier is an individual or a company that provides Imatinib active pharmaceutical ingredient (API) or Imatinib finished formulations upon request. The Imatinib suppliers may include Imatinib API manufacturers, exporters, distributors and traders.

click here to find a list of Imatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Imatinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Imatinib Drug Master File in Korea (Imatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imatinib. The MFDS reviews the Imatinib KDMF as part of the drug registration process and uses the information provided in the Imatinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Imatinib 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 Imatinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Imatinib suppliers with KDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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