Synopsis
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DRUG PRODUCT COMPOSITIONS
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1. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
2. Amn 107
3. Amn-107
4. Amn107
5. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)
6. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate
7. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:1:2)
8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:2:2)
9. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (2:2:3)
10. Nilotinib
11. Nilotinib Dihydrochloride Dihydrate
12. Nilotinib Hydrochloride Anhydrous
13. Nilotinib Hydrochloride Dihydrate
14. Nilotinib Hydrochloride Hydrate
15. Nilotinib Hydrochloride Monohydrate
16. Nilotinib Hydrochloride Sesquihydrate
17. Tasigna
1. 923288-95-3
2. Nilotinib Hydrochloride Anhydrous
3. Nilotinib Hcl
4. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide Hydrochloride
5. Nilotinib (hydrochloride)
6. K37n7byx3x
7. 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride
8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)
9. Nilotinib (as Hydrochloride)
10. Unii-k37n7byx3x
11. Amn 107 Hydrochloride
12. Amn-107 Hcl
13. Schembl434496
14. Dtxsid60238968
15. Bcp29532
16. Hy-10159b
17. S5205
18. Ccg-270077
19. Nilotinib Hydrochloride [vandf]
20. Bn164657
21. Nilotinib Hydrochloride Monohydrate- Bio-x
22. Cs-0085192
23. Nilotinib Hydrochloride [orange Book]
24. Nilotinib Hydrochloride Anhydrous [who-dd]
25. Q27281888
26. Nilotinib Hcl;amn 107; Amn107; Amn-107; Nilotinib Hydrochloride Anhydrous
27. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamidehydrochloride
28. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide Hydrochloride
29. 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide Hydrochloride
Molecular Weight | 566.0 g/mol |
---|---|
Molecular Formula | C28H23ClF3N7O |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 6 |
Exact Mass | 565.1604706 g/mol |
Monoisotopic Mass | 565.1604706 g/mol |
Topological Polar Surface Area | 97.6 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 817 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-16
Pay. Date : 2016-02-04
DMF Number : 30088
Submission : 2015-12-31
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-979
Start Marketing Date : 2015-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2024-01-23
Registration Number : No. 574-23-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India
Available Reg Filing : BR, CA, CN |
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Granules 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
NDC Package Code : 62207-984
Start Marketing Date : 2022-09-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (600g/600g)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-13
Pay. Date : 2014-03-19
DMF Number : 28102
Submission : 2014-07-15
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-15
Pay. Date : 2022-08-22
DMF Number : 37161
Submission : 2022-07-08
Status : Active
Type : II
NDC Package Code : 55111-979
Start Marketing Date : 2015-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2024-01-23
Registration Number : No. 574-23-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO Unit-VI, APIIC Industrial Estate, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh - 532 409, India
Available Reg Filing : BR, CA, CN |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-28
Pay. Date : 2020-05-13
DMF Number : 34874
Submission : 2020-07-14
Status : Active
Type : II
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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.
A Nilotinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilotinib Hydrochloride, including repackagers and relabelers. The FDA regulates Nilotinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilotinib Hydrochloride 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilotinib Hydrochloride supplier is an individual or a company that provides Nilotinib Hydrochloride active pharmaceutical ingredient (API) or Nilotinib Hydrochloride finished formulations upon request. The Nilotinib Hydrochloride suppliers may include Nilotinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Nilotinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilotinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilotinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Nilotinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Nilotinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilotinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Nilotinib Hydrochloride USDMF includes data on Nilotinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilotinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilotinib Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nilotinib Hydrochloride Drug Master File in Japan (Nilotinib Hydrochloride JDMF) empowers Nilotinib Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nilotinib Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Nilotinib Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nilotinib Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nilotinib Hydrochloride Drug Master File in Korea (Nilotinib Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nilotinib Hydrochloride. The MFDS reviews the Nilotinib Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Nilotinib Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nilotinib Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nilotinib Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nilotinib Hydrochloride suppliers with KDMF on PharmaCompass.
A Nilotinib Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Nilotinib Hydrochloride Certificate of Suitability (COS). The purpose of a Nilotinib Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilotinib Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilotinib Hydrochloride to their clients by showing that a Nilotinib Hydrochloride CEP has been issued for it. The manufacturer submits a Nilotinib Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilotinib Hydrochloride CEP holder for the record. Additionally, the data presented in the Nilotinib Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilotinib Hydrochloride DMF.
A Nilotinib Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilotinib Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nilotinib Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Nilotinib Hydrochloride written confirmation (Nilotinib Hydrochloride WC) is an official document issued by a regulatory agency to a Nilotinib Hydrochloride manufacturer, verifying that the manufacturing facility of a Nilotinib Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilotinib Hydrochloride APIs or Nilotinib Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilotinib Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Nilotinib Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nilotinib Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nilotinib Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Nilotinib Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Nilotinib Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilotinib Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nilotinib Hydrochloride suppliers with NDC on PharmaCompass.
Nilotinib Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Nilotinib Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Nilotinib Hydrochloride GMP manufacturer or Nilotinib Hydrochloride GMP API supplier for your needs.
A Nilotinib Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Nilotinib Hydrochloride's compliance with Nilotinib Hydrochloride specifications and serves as a tool for batch-level quality control.
Nilotinib Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Nilotinib Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Nilotinib Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilotinib Hydrochloride EP), Nilotinib Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilotinib Hydrochloride USP).