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

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01 Dr. Reddy's Laboratories (2)

02 Sun Pharmaceutical Industries Limited (1)

03 Teva API (2)

04 Cipla (1)

05 F.I.S. Fabbrica Italiana Sintetici (1)

06 Granules India Limited (1)

07 Hetero Drugs (1)

08 Hikma Pharmaceuticals (1)

09 MSN Laboratories (3)

10 Natco Pharma (1)

11 Shilpa Medicare (1)

12 Sichuan Xieli Pharmaceutical (1)

13 Suzhou Lixin Pharmaceutical (1)

14 Teva Pharmaceutical Industries (1)

15 Zhejiang Jiuzhou Pharmaceutical (2)

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01 NILOTINIB (3)

02 NILOTINIB BUTANEDISULFONATE (1)

03 NILOTINIB D-TARTRATE (1)

04 NILOTINIB DIHYDROCHLORIDE DIHYDRATE (1)

05 NILOTINIB HYDROCHLORIDE (2)

06 NILOTINIB HYDROCHLORIDE (MONOHYDRATE) (1)

07 NILOTINIB HYDROCHLORIDE DIHYDRATE (1)

08 NILOTINIB HYDROCHLORIDE FORM ALPHA (1)

09 NILOTINIB HYDROCHLORIDE MONOHYDRATE (4)

10 NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1) (1)

11 NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1) (1)

12 NILOTINIB HYDROCHLORIDE SESQUIHYDRATE (1)

13 NILOTINIB MONOHYDROCHLORIDE ANHYDROUS (1)

14 NILOTINIB TARTRATE (1)

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01 China (4)

02 India (11)

03 Israel (3)

04 Italy (1)

05 United Kingdom (1)

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01 Active (17)

02 Inactive (3)

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01 Complete (10)

02 Blank (10)

URL Supplier Web Content
35436
Active
2020-12-24
N/A
II
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34874
Active
2020-07-14
Complete
2020-08-28
2020-05-13
II
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28102
Active
2014-07-15
Complete
2014-08-13
2014-03-19
II
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31740
Active
2017-06-30
Complete
2017-10-20
2017-05-11
II
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30098
Active
2015-12-09
Complete
2016-07-05
2016-05-05
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30164
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2015-12-29
N/A
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32661
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2018-03-30
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31693
Active
2017-04-14
Complete
2019-06-04
2017-05-17
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Looking for 923288-95-3 / Nilotinib API manufacturers, exporters & distributors?

Nilotinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Nilotinib 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 Nilotinib manufacturer or Nilotinib supplier for your needs.

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

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

API | Excipient name

Nilotinib

Synonyms

923288-95-3, Nilotinib hydrochloride anhydrous, Nilotinib hcl, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride, Nilotinib (hydrochloride), K37n7byx3x

Cas Number

923288-95-3

Unique Ingredient Identifier (UNII)

K37N7BYX3X

About Nilotinib

Nilotinib Hydrochloride Anhydrous is the hydrochloride salt of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. This agent also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R) and c-kit, a receptor tyrosine kinase mutated and constitutively activated in most gastrointestinal stromal tumors (GISTs). With a binding mode that is energetically more favorable than that of imatinib, nilotinib has been shown to have an approximately 20-fold increased potency in kinase and proliferation assays compared to imatinib.

Nilotinib HCl Manufacturers

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

Nilotinib HCl Suppliers

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

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

Nilotinib HCl USDMF

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

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

click here to find a list of Nilotinib HCl 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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