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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2016-03-16

Pay. Date : 2016-02-04

DMF Number : 30088

Submission : 2015-12-31

Status : Active

Type : II

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37531

Submission : 2022-09-30

Status : Active

Type : II

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-13

Pay. Date : 2014-03-19

DMF Number : 28102

Submission : 2014-07-15

Status : Active

Type : II

TAPI Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2022-09-15

Pay. Date : 2022-08-22

DMF Number : 37161

Submission : 2022-07-08

Status : Active

Type : II

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-28

Pay. Date : 2020-05-13

DMF Number : 34874

Submission : 2020-07-14

Status : Active

Type : II

TAPI Company Banner

06

The Generic Rx Session
Not Confirmed

07

The Generic Rx Session
Not Confirmed

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 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.

Nilotinib USDMF

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

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

click here to find a list of Nilotinib 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.