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List of all Manufacturers, Suppliers & Exporters of Nilotinib API listed on PharmaCompass with details of regulatory filings

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01 Aarti Pharmalabs (1)

02 ChemWerth Inc (1)

03 Rochem International Inc (1)

04 Dr. Reddy's Laboratories (2)

05 Supriya Lifescience (1)

06 LGM Pharma (1)

07 HRV Global Life Sciences (1)

08 Sichuan Elixir Pharmaceuticals (1)

09 Tofigh Daru (1)

10 Acebright India Pharma Private Limited (1)

11 Baran Chemical and Pharmaceutical (1)

12 Biocon (1)

13 Biotechnica DWC (1)

14 Cdymax (1)

15 Cipla (1)

16 Deva Holding AS (1)

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

18 Granules India Limited (1)

19 Guangzhou Tosun Pharmaceutical (1)

20 Hangzhou Longshine Bio-Tech (1)

21 Hetero Drugs (1)

22 Hikma Pharmaceuticals (1)

23 Jeil Pharmaceutical Co., Ltd (1)

24 Jin Dun Medical (1)

25 Jiwan Pharmaceutical Technology Co., Ltd (1)

26 Laurus Labs (1)

27 MSN Laboratories (3)

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

29 NEWEDGE Overseas (1)

30 Natco Pharma Limited (1)

31 Shenzhen Haorui (1)

32 Shilpa Medicare (2)

33 Sichuan Qingmu Pharmaceutical (1)

34 Sichuan Xieli Pharmaceutical (1)

35 Sun Pharmaceutical Industries Limited (1)

36 Suzhou Lixin Pharmaceutical (1)

37 Tecoland Corporation (1)

38 Teva API (2)

39 Teva Pharmaceutical Industries (1)

40 Vannsh Life Sciences (1)

41 Zhejiang Jiuzhou Pharmaceutical (2)

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01 Algeria (1)

02 China (11)

03 India (22)

04 Iran (2)

05 Israel (3)

06 Italy (1)

07 South Korea (1)

08 Turkey (1)

09 U.S.A (4)

10 United Kingdom (1)

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01 Active (17)

02 Inactive (3)

03 Blank (27)

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01 Valid (2)

02 Blank (45)

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01 Blank (47)

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01 WC-0014A5 (1)

02 WC-0041 (1)

03 WC-0067n (1)

04 WC-0099 (1)

05 WC-0349 (1)

06 WC-0349A3 (1)

07 WC-0349A8 (1)

08 Blank (40)

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Application Number
Indian CDSCO WC-0099
Status
 
Valid
2025-07-29
Filing Details
Nilotinib Hydrochloride IH
Issue/Submission Date
2023-01-06
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Application Number
30088
Indian CDSCO WC-0067n
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-07
Filing Details
NILOTINIB HYDROCHLORIDE
Nilotinib hydrochloride anhydrous I...
Issue/Submission Date
2015-12-31
2022-06-17
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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Interphex 2024

Not Confirmed

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Application Number
37161
Status
Active
Fees Paid
Reviewed
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Issue/Submission Date
2022-07-08
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Application Number
32661
R0-CEP 2020-176 - Rev 00
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
NILOTINIB HYDROCHLORIDE (MONOHYDRAT...
Nilotinib hydrochloride monohydrate
Nilotinib HCl IH
Issue/Submission Date
2018-03-30
2022-12-06
2022-09-02
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Application Number
33196
Indian CDSCO WC-0349A8
Status
Active
Fees Paid
N/A
 
Expired
2022-05-05
Filing Details
NILOTINIB
Nilotinib IH
Issue/Submission Date
2018-09-29
2020-02-10
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Application Number
35729
Indian CDSCO WC-0349A3
Status
Active
Fees Paid
Reviewed
 
Expired
2022-05-05
Filing Details
NILOTINIB HYDROCHLORIDE SESQUIHYDRA...
Nilotinib HCl IH
Issue/Submission Date
2021-03-20
2019-08-05
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Application Number
28102
Status
Active
Fees Paid
Reviewed
 
Filing Details
NILOTINIB HYDROCHLORIDE
Issue/Submission Date
2014-07-15
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Application Number
34874
Status
Active
Fees Paid
Reviewed
 
Filing Details
NILOTINIB HYDROCHLORIDE FORM ALPHA
Issue/Submission Date
2020-07-14
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Application Number
36289
Status
Active
Fees Paid
Reviewed
 
Filing Details
NILOTINIB
Issue/Submission Date
2021-09-21
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Application Number
36779
Status
Active
Fees Paid
N/A
 
Filing Details
NILOTINIB D-TARTRATE
Issue/Submission Date
2022-02-28
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Application Number
31740
Status
Active
Fees Paid
Reviewed
 
Filing Details
NILOTINIB DIHYDROCHLORIDE DIHYDRATE
Issue/Submission Date
2017-06-30
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Application Number
31693
R0-CEP 2021-133 - Rev 00
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Nilotinib hydrochloride monohydrate
Issue/Submission Date
2017-04-14
2023-07-21
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Application Number
36308
Indian CDSCO WC-0014A5
Status
Active
Fees Paid
Reviewed
 
Expired
2022-06-25
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Nilotinib Hydrochloride Monohydrate...
Issue/Submission Date
2022-12-02
2021-08-06
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Application Number
30164
Status
Active
Fees Paid
N/A
 
Filing Details
NILOTINIB MONOHYDROCHLORIDE ANHYDRO...
Issue/Submission Date
2015-12-29
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Application Number
30098
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
 
Valid
2025-08-08
Filing Details
NILOTINIB HYDROCHLORIDE DIHYDRATE
Nilotinib HCl (IH)
Issue/Submission Date
2015-12-09
2022-09-16
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Application Number
35436
Status
Active
Fees Paid
N/A
 
Filing Details
NILOTINIB BUTANEDISULFONATE
Issue/Submission Date
2020-12-24
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Application Number
37531
Status
Active
Fees Paid
N/A
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Issue/Submission Date
2022-09-30
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Application Number
37242
Status
Active
Fees Paid
N/A
 
Filing Details
NILOTINIB TARTRATE
Issue/Submission Date
2022-09-06
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Application Number
26497
Status
Inactive
Fees Paid
N/A
 
Filing Details
NILOTINIB
Issue/Submission Date
2012-09-28
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Application Number
25338
Status
Inactive
Fees Paid
N/A
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE...
Issue/Submission Date
2011-09-28
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Application Number
25412
Status
Inactive
Fees Paid
N/A
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE...
Issue/Submission Date
2011-10-19
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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 Manufacturers

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

Nilotinib Suppliers

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

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