Synopsis
Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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1. Azd-9291
2. Azd-9291 Mesylate
3. Azd9291
4. Azd9291 Mesylate
5. Mereletinib
6. Mereletinib Mesilate
7. Mereletinib Mesylate
8. N-(2-((2-(dimethylamino)ethyl)methylamino)-4-methoxy-5-((4-(1-methyl-1h-indol-3-yl)-2-pyrimidinyl)amino)phenyl)-2-propenamide
9. N-(2-((2-(dimethylamino)ethyl)methylamino)-4-methoxy-5-((4-(1-methyl-1h-indol-3-yl)-2-pyrimidinyl)amino)phenyl)-2-propenamide Methanesulfonate (1:1)
10. Osimertinib
11. Osimertinib Mesilate
12. Tagrisso
1. 1421373-66-1
2. Azd-9291 Mesylate
3. Azd9291 Mesylate
4. Azd-9291 (mesylate)
5. Mereletinib Mesylate
6. Tagrisso
7. Osimertinib Mesilate
8. Mereletinib Mesilate
9. Osimertinib Mesylate [usan]
10. Rdl94r2a16
11. N-[2-[2-(dimethylamino)ethyl-methylamino]-4-methoxy-5-[[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino]phenyl]prop-2-enamide;methanesulfonic Acid
12. N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1h-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide Methanesulfonate
13. Osimertinib Mesilate (jan)
14. Osimertinib Mesylate (usan)
15. 2-propenamide, N-(2-((2-(dimethylamino)ethyl)methylamino)-4-methoxy-5-((4-(1-methyl-1h-indol-3-yl)-2-pyrimidinyl)amino)phenyl)-, Methanesulfonate (1:1)
16. Osimertinib Mesilate [jan]
17. 2-propenamide, N-[2-[[2-(dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methyl-1h-indol-3-yl)-2-pyrimidinyl]amino]phenyl]-, Compd. With Methanesulfonate (1:2)
18. Unii-rdl94r2a16
19. Tagrisso (tn)
20. Osimertinib Monomesylate
21. Azd 9291 Mesylate
22. Osimertinib Methanesulfonate
23. Amy226
24. Chembl3545063
25. Schembl14661152
26. Chebi:90948
27. Osimertinib Mesylate [mi]
28. Dtxsid101027822
29. Bcp09934
30. Ex-a1577
31. Hy-15772a
32. Mfcd28137994
33. Osimertinib Mesilate [who-dd]
34. Akos026673944
35. Ds-9913
36. Sb22953
37. Ac-29022
38. Da-35303
39. Osimertinib Mesylate [orange Book]
40. Azd-9291 Mesylate (osimertinibmereletinib)
41. Ft-0699962
42. S5078
43. D10766
44. Q27162942
45. Azd9291 Ms Salt, Osimertinib Ms Salt; Mereletinib Ms Salt
46. N-(2-{[2-(dimethylamino)ethyl](methyl)amino}-4-methoxy-5-{[4-(1-methyl-1h-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide Methanesulfonate
47. N-[2-[[2-(dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methyl-1h-indol-3-yl)-2-pyrimidinyl]amino]phenyl]-2-propenamide Methanesulfonate
1. Osimertinib
Molecular Weight | 595.7 g/mol |
---|---|
Molecular Formula | C29H37N7O5S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 10 |
Exact Mass | 595.25768848 g/mol |
Monoisotopic Mass | 595.25768848 g/mol |
Topological Polar Surface Area | 150 Ų |
Heavy Atom Count | 42 |
Formal Charge | 0 |
Complexity | 845 |
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 |
TAGRISSO as monotherapy is indicated for:
-the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
- the first-line treatment of adult patients NSCLC with activating EGFR mutations.
- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
TAGRISSO as monotherapy is indicated for:
- the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
- the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
L01XE
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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4-Fluoro-2-methoxy-5-nitroaniline
CAS Number : 1075705-01-9
End Use API : Osimertinib Mesylate
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
N-(4-Fluoro-2-methoxy-5-nitrophenyl)-4-(1-methyl-1...
CAS Number : 1421372-94-2
End Use API : Osimertinib Mesylate
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
4-Fluoro-2-methoxy-5-nitro aniline
CAS Number : 1075705-01-9
End Use API : Osimertinib Mesylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
3-(2-Chloropyrimidin-4-yl)1-methyl indole
CAS Number : 1032452-86-0
End Use API : Osimertinib Mesylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
N-(4-Fluoro-2-methoxy-5-nitro phenyl)-4-(1-methyl-...
CAS Number : 1421372-94-2
End Use API : Osimertinib Mesylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
N,N,N'-Trimethylethylenediamine
CAS Number : 142-25-6
End Use API : Osimertinib Mesylate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
3-(2-chloropyrimidin-4-yl)-1-methyl-1H-indole
CAS Number : 1032452-86-0
End Use API : Osimertinib Mesylate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
N-(4-fluoro-2-methoxy-5-nitrophenyl)-4-(1-methyl-1...
CAS Number : 1421372-94-2
End Use API : Osimertinib Mesylate
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N1-(2-(dimethylamino)ethyl)-5-methoxy-N1-methyl-N4...
CAS Number : 1421372-67-9
End Use API : Osimertinib Mesylate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
N1-(2-(dimethylamino)ethyl)-5-methoxy-N1-methyl-N4...
CAS Number : 1421372-66-8
End Use API : Osimertinib Mesylate
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Regulatory Info :
Registration Country : Iran
Brand Name : Mertisso
Dosage Form : Film Coated Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Mertisso
Dosage Form : Film Coated Tablet
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info :
Registration Country : Switzerland
Brand Name : Tagrisso
Dosage Form : Tabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
OSIMERTINIB (OSIMERTINIB MESYLATE)
Brand Name : TAGRISSO
Dosage Form : TABLET
Dosage Strength : 40MG
Packaging : 30
Approval Date :
Application Number : 2456214
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Tagrisso 80 mg
Dosage Form : FCT
Dosage Strength : 80mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Tagrisso
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Tagrisso
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
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PharmaCompass offers a list of Osimertinib Mesylate 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 Osimertinib Mesylate manufacturer or Osimertinib Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Osimertinib Mesylate manufacturer or Osimertinib Mesylate supplier.
PharmaCompass also assists you with knowing the Osimertinib Mesylate API Price utilized in the formulation of products. Osimertinib Mesylate API Price is not always fixed or binding as the Osimertinib Mesylate Price is obtained through a variety of data sources. The Osimertinib Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Osimertinib Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osimertinib Mesylate, including repackagers and relabelers. The FDA regulates Osimertinib Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osimertinib Mesylate 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 Osimertinib Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osimertinib Mesylate supplier is an individual or a company that provides Osimertinib Mesylate active pharmaceutical ingredient (API) or Osimertinib Mesylate finished formulations upon request. The Osimertinib Mesylate suppliers may include Osimertinib Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Osimertinib Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Osimertinib Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Osimertinib Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Osimertinib Mesylate DMFs exist exist since differing nations have different regulations, such as Osimertinib Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Osimertinib Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Osimertinib Mesylate USDMF includes data on Osimertinib Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Osimertinib Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Osimertinib Mesylate suppliers with USDMF 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 Osimertinib Mesylate Drug Master File in Korea (Osimertinib Mesylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Osimertinib Mesylate. The MFDS reviews the Osimertinib Mesylate KDMF as part of the drug registration process and uses the information provided in the Osimertinib Mesylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Osimertinib Mesylate 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 Osimertinib Mesylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Osimertinib Mesylate suppliers with KDMF on PharmaCompass.
A Osimertinib Mesylate written confirmation (Osimertinib Mesylate WC) is an official document issued by a regulatory agency to a Osimertinib Mesylate manufacturer, verifying that the manufacturing facility of a Osimertinib Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Osimertinib Mesylate APIs or Osimertinib Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Osimertinib Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Osimertinib Mesylate 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 Osimertinib Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Osimertinib Mesylate 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 Osimertinib Mesylate 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 Osimertinib Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Osimertinib Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Osimertinib Mesylate suppliers with NDC on PharmaCompass.
Osimertinib Mesylate 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 Osimertinib Mesylate 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 Osimertinib Mesylate GMP manufacturer or Osimertinib Mesylate GMP API supplier for your needs.
A Osimertinib Mesylate CoA (Certificate of Analysis) is a formal document that attests to Osimertinib Mesylate's compliance with Osimertinib Mesylate specifications and serves as a tool for batch-level quality control.
Osimertinib Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Osimertinib Mesylate 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.
Osimertinib Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Osimertinib Mesylate EP), Osimertinib Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Osimertinib Mesylate USP).