Synopsis
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CEP/COS
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1. (+)-osilodrostat
2. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-benzonitrile
3. Benzonitrile, 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-
4. Isturisa
5. Lci699
6. Osilodrostat
1. 1315449-72-9
2. Lci699-aza
3. Unii-y6581yaw9v
4. Osilodrostat Phosphate [usan]
5. Y6581yaw9v
6. Isturisa
7. Osilodrostat(lci699) Phosphate
8. Osilodrostat (phosphate)
9. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluorobenzonitrile Dihydrogen Phosphate
10. 4-[(5r)-6,7-dihydro-5h-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile;phosphoric Acid
11. Benzonitrile, 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluoro-, Phosphate (1:1)
12. Isturisa (tn)
13. 4-[(5r)-6,7-dihydro-5h-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile Dihydrogen Phosphate
14. Chembl3707393
15. Schembl13837602
16. Dtxsid401027857
17. Osilodrostat Phosphate [mi]
18. Osilodrostat Phosphate (jan/usan)
19. Osilodrostat Phosphate [jan]
20. Hy-16276a
21. Akos040749099
22. Osilodrostat Phosphate [who-dd]
23. Da-76469
24. Osilodrostat Phosphate [orange Book]
25. Cs-0068058
26. D11062
27. Q27294304
28. 4-((5r)-6,7-dihydro-5h-pyrrolo(1,2-c)imidazol-5-yl)-3-fluorobenzonitrile Monophosphate
1. Lci699
2. Osilodrostat
3. Osilodrostat (lci699)
4. Osilodrostat Free Base
| Molecular Weight | 325.23 g/mol |
|---|---|
| Molecular Formula | C13H13FN3O4P |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 1 |
| Exact Mass | g/mol |
| Monoisotopic Mass | g/mol |
| Topological Polar Surface Area | 119 |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 387 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Isturisa is indicated for the treatment of endogenous Cushing's syndrome in adults.
H02CA02
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40908
Submission : 2025-01-07
Status : Active
Type : II

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Regulatory Info :
Registration Country :
Brand Name : Isturisa
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

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Brand Name : Isturisa
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

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Brand Name : Isturisa
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country :

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Regulatory Info : RX
Registration Country : USA
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2020-03-06
Application Number : 212801
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 5MG BASE
Packaging :
Approval Date : 2020-03-06
Application Number : 212801
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2020-03-06
Application Number : 212801
Regulatory Info : DISCN
Registration Country : USA

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Registration Country : Australia
Brand Name : Isturisa
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Dosage Strength :
Packaging : 60
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Regulatory Info :
Registration Country : Australia

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Registration Country : Australia

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Isturisa
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date : 2021-02-12
Application Number : 1191407001
Regulatory Info : Authorized
Registration Country : Spain

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Brand Name : Isturisa
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date : 2021-02-12
Application Number : 1171409002
Regulatory Info : Authorized
Registration Country : Spain

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RLD : Yes
TE Code :
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Approval Date : 2020-03-06
Application Number : 212801
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 5MG BASE
Approval Date : 2020-03-06
Application Number : 212801
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : ISTURISA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2020-03-06
Application Number : 212801
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Isturisa
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date : 2021-02-12
Application Number : 1191407001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Isturisa
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date : 2021-02-12
Application Number : 1171409002
Regulatory Info : Authorized
Registration Country : Spain

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Registration Country : Spain
Brand Name : Isturisa
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2021-02-12
Application Number : 1191407003
Regulatory Info : Authorized
Registration Country : Spain

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ABOUT THIS PAGE
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PharmaCompass offers a list of Osilodrostat Phosphate 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 Osilodrostat Phosphate manufacturer or Osilodrostat Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Osilodrostat Phosphate manufacturer or Osilodrostat Phosphate supplier.
PharmaCompass also assists you with knowing the Osilodrostat Phosphate API Price utilized in the formulation of products. Osilodrostat Phosphate API Price is not always fixed or binding as the Osilodrostat Phosphate Price is obtained through a variety of data sources. The Osilodrostat Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Osilodrostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osilodrostat, including repackagers and relabelers. The FDA regulates Osilodrostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osilodrostat 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 Osilodrostat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osilodrostat supplier is an individual or a company that provides Osilodrostat active pharmaceutical ingredient (API) or Osilodrostat finished formulations upon request. The Osilodrostat suppliers may include Osilodrostat API manufacturers, exporters, distributors and traders.
click here to find a list of Osilodrostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Osilodrostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Osilodrostat active pharmaceutical ingredient (API) in detail. Different forms of Osilodrostat DMFs exist exist since differing nations have different regulations, such as Osilodrostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Osilodrostat DMF submitted to regulatory agencies in the US is known as a USDMF. Osilodrostat USDMF includes data on Osilodrostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Osilodrostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Osilodrostat suppliers with USDMF on PharmaCompass.
Osilodrostat 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 Osilodrostat 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 Osilodrostat GMP manufacturer or Osilodrostat GMP API supplier for your needs.
A Osilodrostat CoA (Certificate of Analysis) is a formal document that attests to Osilodrostat's compliance with Osilodrostat specifications and serves as a tool for batch-level quality control.
Osilodrostat CoA mostly includes findings from lab analyses of a specific batch. For each Osilodrostat 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.
Osilodrostat may be tested according to a variety of international standards, such as European Pharmacopoeia (Osilodrostat EP), Osilodrostat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Osilodrostat USP).