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List of Korea Drug Master Files (KDMF) for Gleevec Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Alvogen Korea Co., Ltd.
2019-06-27
Number 522-2-ND
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Toru Co., Ltd.
2023-02-16
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Korea United Pharmaceutical Co., Ltd.
2012-06-26
Number 4838-12-ND(1)
Cipla Limited
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Cipla Ltd. plot No.285,28...
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Chong Kun Dang Co., Ltd.
2013-04-05
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Cipla Limited
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Ildong Pharmaceutical Co., Ltd.
2013-08-12
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Cipla Limited.
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UNUST Co., Ltd.
2010-12-30
Number 4838-12-ND
Cipla Limited
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Novartis Korea Co., Ltd.
2022-10-18
Wed196-24-ND
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Via Massimo D'Antona, 13,...
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Sungwoo Chemical Co., Ltd.
2019-09-02
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2022-04-08
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Jeil Pharmaceutical Co., Ltd.
2012-08-03
21-7-ND
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Kyungbo Pharmaceutical Co., Ltd.
2012-03-30
459-8-ND
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174, Silok-ro, Asan-si, C...
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Kyungbo Pharmaceutical Co., Ltd.
2020-06-23
1673-35-ND
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UN Generic Co., Ltd.
2014-09-24
Number 6321-4-ND
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2022-08-04
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2011-10-14
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2010-11-16
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2020-01-08
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Sungwoo Chemical Co., Ltd.
2017-08-03
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Nosch Labs Pvt. Ltd
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HK Innoen Co., Ltd.
2013-10-31
Number 3838-5-ND(1)
Nosch Labs Pvt. Ltd
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Wonpoong Pharmaceutical Co., Ltd.
2012-08-03
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Novartis Korea Co., Ltd.
2005-09-08
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Samo Pharmaceutical Co., Ltd.
2013-03-08
711-14-ND
PLIVA Croatia Ltd.
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Sampoong Pharmachem Co., Ltd.
2016-04-05
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Samhwa Biopharm Co., Ltd.
2009-04-29
1575-2-ND
Samhwa Biopharm Co., Ltd.
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Masung LS Co., Ltd.
2012-03-02
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Seongui Bio Co., Ltd.
2013-10-20
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Shilpa Medicare Limited
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Shinpoong Pharmaceutical Co., Ltd.
2013-04-10
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ST Pharm Co., Ltd.
2013-04-05
1290-5-ND
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Dasan Pharmaceutical Co., Ltd.
2010-11-30
763-4-ND
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Kookjeon Pharmaceutical Co., Ltd.
2014-04-02
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Suven Life Sciences Ltd
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Leeyeon Pharmaceutical Co., Ltd.
2014-08-13
1298-3-ND
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  • TABLET;ORAL - EQ 100MG BASE
  • TABLET;ORAL - EQ 400MG BASE

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.

Gleevec Manufacturers

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.

Gleevec Suppliers

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.

Gleevec KDMF

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.

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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