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

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    Nilotinib Hydrochloride Monohydrate

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    01 Aarti Pharmalabs (1)

    02 ChemWerth Inc (1)

    03 LGM Pharma (1)

    04 Rochem International Inc (1)

    05 Dr. Reddy's Laboratories (2)

    06 Sun Pharmaceutical Industries Limited (1)

    07 HRV Global Life Sciences (1)

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

    09 NEWEDGE Overseas (1)

    10 Sichuan Elixir Pharmaceuticals (1)

    11 Teva API (2)

    12 Tofigh Daru (1)

    13 Acebright India Pharma Private Limited (1)

    14 Baran Chemical and Pharmaceutical (1)

    15 Biotechnica DWC (1)

    16 Cdymax (1)

    17 Cipla (1)

    18 Deva Holding AS (1)

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

    20 Granules India Limited (1)

    21 Guangzhou Tosun Pharmaceutical (1)

    22 Hangzhou Longshine Bio-Tech (1)

    23 Hetero Drugs (1)

    24 Hikma Pharmaceuticals (1)

    25 Jeil Pharmaceutical Co., Ltd (1)

    26 Jin Dun Medical (1)

    27 Jiwan Pharmaceutical Technology Co., Ltd (1)

    28 Laurus Labs (1)

    29 MSN Laboratories (3)

    30 Natco Pharma (1)

    31 Shenzhen Haorui (1)

    32 Shilpa Medicare (2)

    33 Sichuan Qingmu Pharmaceutical (1)

    34 Sichuan Xieli Pharmaceutical (1)

    35 Suzhou Lixin Pharmaceutical (1)

    36 Tecoland Corporation (1)

    37 Teva Pharmaceutical Industries (1)

    38 Vannsh Life Sciences (1)

    39 Zhejiang Jiuzhou Pharmaceutical (2)

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    09 U.S.A (4)

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    Aarti Pharmalabs

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    Nilotinib

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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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    CPhI China

    Booth #E1C28

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    ChemWerth Inc

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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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    LGM Pharma

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    LGM Pharma CB

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    Booth #642

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    Rochem International Inc

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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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    Rochem

    CPhI North America

    Booth #1250

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    Dr. Reddy's Laboratories

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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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    HRV Global Life Sciences

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      Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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      RDD 2024

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      Sichuan Elixir Pharmaceuticals

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        Virtual BoothSichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CM/CDMO service provider for anti-tumor characteristic APIs.
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        Sichuan Elixir Pharmaceuticals

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        Tofigh Daru

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          Tofigh Daru

          CPhI Worldwide, Milan

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          Dr. Reddy's Laboratories

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          Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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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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          Sun Pharmaceutical Industries Limit...

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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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          Looking for 923288-95-3 / Nilotinib API manufacturers, exporters & distributors?

          Nilotinib manufacturers, exporters & distributors 1

          53

          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 Hydrochloride Monohydrate Manufacturers

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

          Nilotinib Hydrochloride Monohydrate Suppliers

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

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

          Nilotinib Hydrochloride Monohydrate Manufacturers | Traders | Suppliers

          Nilotinib Hydrochloride Monohydrate Manufacturers, Traders, Suppliers 1
          94

          We have 39 companies offering Nilotinib Hydrochloride Monohydrate

          Get in contact with the supplier of your choice:

          1. ChemWerth Inc
          2. LGM Pharma
          3. Rochem International Inc
          4. Dr. Reddy's Laboratories
          5. Sun Pharmaceutical Industries Limited
          6. Aarti Pharmalabs
          7. HRV Global Life Sciences
          8. Mac-Chem Products (India) Pvt.Ltd
          9. NEWEDGE Overseas
          10. Sichuan Elixir Pharmaceuticals
          11. Teva API
          12. Tofigh Daru
          13. Acebright India Pharma Private Limited
          14. Baran Chemical and Pharmaceutical
          15. Biotechnica DWC
          16. Cdymax
          17. Cipla
          18. Deva Holding AS
          19. F.I.S. Fabbrica Italiana Sintetici
          20. Granules India Limited
          21. Guangzhou Tosun Pharmaceutical
          22. Hangzhou Longshine Bio-Tech
          23. Hetero Drugs
          24. Hikma Pharmaceuticals
          25. Jeil Pharmaceutical Co., Ltd
          26. Jin Dun Medical
          27. Jiwan Pharmaceutical Technology Co., Ltd
          28. Laurus Labs
          29. MSN Laboratories
          30. Natco Pharma
          31. Shenzhen Haorui
          32. Shilpa Medicare
          33. Sichuan Qingmu Pharmaceutical
          34. Sichuan Xieli Pharmaceutical
          35. Suzhou Lixin Pharmaceutical
          36. Tecoland Corporation
          37. Teva Pharmaceutical Industries
          38. Vannsh Life Sciences
          39. Zhejiang Jiuzhou Pharmaceutical
          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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