Synopsis
Synopsis
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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Weekly News Recap #Phispers
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.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36546
Submission : 2021-12-24
Status : Active
Type : II
NDC Package Code : 54245-1451
Start Marketing Date : 2022-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-06
Pay. Date : 2019-03-14
DMF Number : 32143
Submission : 2017-12-29
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0068
Start Marketing Date : 2017-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-04-25
Registration Number : Number 173-37-ND
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pincode: 502 300, India.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-05-22
Registration Number : 434-56-ND
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : API Division Karakhadi, Plot No. 842-843 Tal-Padra, City : Karakhadi-391 450, Dist : ...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-04-27
Registration Number : Su248-18-ND
Manufacturer Name : Dottikon Exclusive Synthesis...
Manufacturer Address : Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2024-03-18
Registration Number : Thu21-24-ND(1)
Manufacturer Name : Hetero Labs Limited(Unit-1)
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2023-12-29
Registration Number : Thu21-24-ND
Manufacturer Name : Hetero Labs Limited Unit-I
Manufacturer Address : Survey No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, SangaReddy District.-50231...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2018-06-20
Registration Number : Su248-10-ND
Manufacturer Name : Lonza AG
Manufacturer Address : Lonzastrasse CH-3930 Visp Switzerland
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-04-25
Registration Number : Number 173-37-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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 : RX
Registration Country : USA
Brand Name : TAGRISSO
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 40MG BASE
Packaging :
Approval Date : 2015-11-13
Application Number : 208065
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Tagrisso
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 80 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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
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