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1. 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-2,4-dioxo-1h-thieno(3,4-d)pyrimidine-5-carboxylic Acid
2. Klh-2109
3. Klh2109
4. Obe-2109
5. Obe2109
1. 935283-04-8
2. Linzagolix [inn]
3. Linzagolix [usan]
4. Obe-2109
5. 7cdw97huex
6. Obe2109
7. Klh-2109
8. Klh-2109; Obe-2109
9. 3-{5-[(2,3-difluoro-6-methoxyphenyl)methoxy]-2-fluoro-4-methoxyphenyl}-2,4-dioxo-1,2,3,4-tetrahydrothieno[3,4-d]pyrimidine-5-carboxylic Acid
10. Thieno(3,4-d)pyrimidine-5-carboxylic Acid, 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-1,2,3,4-tetrahydro-2,4-dioxo-
11. 3-(5-((2,3-difluoro-6-methoxyphenyl)methoxy)-2-fluoro-4-methoxyphenyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno(3,4-d)pyrimidine-5-carboxylic Acid
12. Linzagolix (usan/inn)
13. Linzagolix [usan:inn]
14. Unii-7cdw97huex
15. Linzagolix [who-dd]
16. Schembl2333748
17. Chembl3668014
18. Bdbm160329
19. Dtxsid801337395
20. Bcp30444
21. Who 10711
22. Hy-109093
23. D11608
24. Us9040693, 233
25. 3-[5-(2,3-difluoro-6-methoxybenzyloxy)-2-fluoro-4-methoxyphenyl]-2,4-dioxo-1,2,3,4-tetrahydrothieno[3,4-d]pyrimidine-5-carboxylic Acid
26. 3-[5-[(2,3-difluoro-6-methoxyphenyl)methoxy]-2-fluoro-4-methoxyphenyl]-2,4-dioxo-1h-thieno[3,4-d]pyrimidine-5-carboxylic Acid
| Molecular Weight | 508.4 g/mol |
|---|---|
| Molecular Formula | C22H15F3N2O7S |
| XLogP3 | 3.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 7 |
| Exact Mass | 508.05520648 g/mol |
| Monoisotopic Mass | 508.05520648 g/mol |
| Topological Polar Surface Area | 143 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 826 |
| 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 | 1 |
H - Systemic hormonal preparations, excl. sex hormones and insulins
H01 - Pituitary and hypothalamic hormones and analogues
H01C - Hypothalamic hormones
H01CC - Anti-gonadotropin-releasing hormones
H01CC04 - Linzagolix
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35700
Submission : 2021-06-03
Status : Active
Type : II

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ABOUT THIS PAGE
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PharmaCompass offers a list of Linzagolix API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Linzagolix manufacturer or Linzagolix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Linzagolix manufacturer or Linzagolix supplier.
A Linzagolix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linzagolix, including repackagers and relabelers. The FDA regulates Linzagolix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linzagolix 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 Linzagolix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Linzagolix supplier is an individual or a company that provides Linzagolix active pharmaceutical ingredient (API) or Linzagolix finished formulations upon request. The Linzagolix suppliers may include Linzagolix API manufacturers, exporters, distributors and traders.
click here to find a list of Linzagolix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Linzagolix DMF (Drug Master File) is a document detailing the whole manufacturing process of Linzagolix active pharmaceutical ingredient (API) in detail. Different forms of Linzagolix DMFs exist exist since differing nations have different regulations, such as Linzagolix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Linzagolix DMF submitted to regulatory agencies in the US is known as a USDMF. Linzagolix USDMF includes data on Linzagolix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Linzagolix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Linzagolix suppliers with USDMF on PharmaCompass.
Linzagolix 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 Linzagolix GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Linzagolix GMP manufacturer or Linzagolix GMP API supplier for your needs.
A Linzagolix CoA (Certificate of Analysis) is a formal document that attests to Linzagolix's compliance with Linzagolix specifications and serves as a tool for batch-level quality control.
Linzagolix CoA mostly includes findings from lab analyses of a specific batch. For each Linzagolix 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.
Linzagolix may be tested according to a variety of international standards, such as European Pharmacopoeia (Linzagolix EP), Linzagolix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Linzagolix USP).