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List of Drug Master Files (DMF) of Imatinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Acebright India Pharma Private Limited (2)

02 Aurobindo Pharma Limited (1)

03 Cipla (2)

04 F.I.S. Fabbrica Italiana Sintetici (2)

05 Formosa Laboratories (1)

06 Hetero Drugs (3)

07 Intas Pharmaceuticals (1)

08 Kyongbo Pharmaceutical Co., Ltd (1)

09 Laurus Labs (2)

10 MSN Laboratories (2)

11 Natco Pharma (1)

12 PHF SA (1)

13 Qilu Tianhe Pharmaceutical Co., Ltd. (1)

14 Reliance Life Sciences Private Limited (1)

15 Shilpa Medicare (2)

16 Sichuan Xieli Pharmaceutical (1)

17 Signa S.A. de C.V. (1)

18 Sun Pharmaceutical Industries Limited (1)

19 Tai Heng Industry Co., Ltd (1)

20 Teva API (2)

21 Viatris (1)

22 Zhejiang Hisun Pharmaceutical (1)

23 Zhejiang Jiuzhou Pharmaceutical (1)

24 Zydus Lifesciences (3)

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01 IMATINIB MESYLATE (17)

02 IMATINIB MESYLATE (A-FORM) (1)

03 IMATINIB MESYLATE (ALPHA 2-FORM) (1)

04 IMATINIB MESYLATE (ALPHA FORM) (1)

05 IMATINIB MESYLATE (AMORPHOUS) (1)

06 IMATINIB MESYLATE (BETA FORM) (2)

07 IMATINIB MESYLATE (FORM-A) (1)

08 IMATINIB MESYLATE (FORM-B) (1)

09 IMATINIB MESYLATE (IMN) (1)

10 IMATINIB MESYLATE (NON-STERILE API) (1)

11 IMATINIB MESYLATE (PROCESS II) (1)

12 IMATINIB MESYLATE (PROCESS-2) (1)

13 IMATINIB MESYLATE (ß-FORM) (1)

14 IMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)] (1)

15 IMATINIB MESYLATE AMORPHOUS (1)

16 IMATINIB MESYLATE FORM ALPHA (1)

17 IMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)] (1)

18 IMATINIB MESYLATE [ROUTE CODE-" IT"] (1)

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01 China (5)

02 India (21)

03 Israel (2)

04 Italy (2)

05 Mexico (1)

06 South Korea (1)

07 Switzerland (1)

08 Taiwan (1)

09 U.S.A (1)

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01 Active (26)

02 Inactive (9)

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01 Complete (16)

02 Blank (19)

URL Supplier Web Content
26322
Active
2012-08-17
N/A
II
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26170
Active
2013-01-23
Complete
2017-02-01
2016-09-28
II
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25206
Active
2011-07-27
Complete
2017-03-24
2015-12-21
II
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25205
Active
2011-07-26
N/A
II
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20410
Active
2007-04-05
Complete
2013-09-28
2013-09-19
II
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24207
Active
2011-03-04
N/A
II
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19499
Active
2006-06-06
N/A
II
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URL Supplier Web Content
24838
Active
2011-03-26
Complete
2014-03-10
2013-12-12
II
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21006
Active
2007-11-02
Complete
2012-11-23
2012-11-08
II
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23343
Active
2009-11-30
N/A
II
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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 USDMF

A Imatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Imatinib active pharmaceutical ingredient (API) in detail. Different forms of Imatinib DMFs exist exist since differing nations have different regulations, such as Imatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Imatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Imatinib USDMF includes data on Imatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Imatinib suppliers with USDMF 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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