Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Contact Supplier

Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

5 API Suppliers, 2 NDC API, 5 Listed Suppliers

5 API Suppliers
2 NDC API
5 Listed Suppliers

DEVELOPMENTS

20 Drugs in Development

20 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 3 FDA Orange Book

3 FDF Dossiers
3 FDA Orange Book

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 47 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
47 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

15 US Patents, 3 US Exclusivities

patents
15 US Patents
3 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as: Sage-217, 1632051-40-1, Zuranolone [inn], Zuranolone [usan], Sge-797, Chembl4105630

Molecular Formula

C₂₅H₃₅N₃O₂

Molecular Weight

409.6 g/mol

InChI Key

HARRKNSQXBRBGZ-GVKWWOCJSA-N

FDA UNII

7ZW49N180B

1 2D Structure

Zuranolone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-[2-[(3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile

2.1.2 InChI

InChI=1S/C25H35N3O2/c1-24(30)9-7-18-17(11-24)3-4-20-19(18)8-10-25(2)21(20)5-6-22(25)23(29)15-28-14-16(12-26)13-27-28/h13-14,17-22,30H,3-11,15H2,1-2H3/t17-,18+,19-,20-,21+,22-,24-,25+/m1/s1

2.1.3 InChI Key

HARRKNSQXBRBGZ-GVKWWOCJSA-N

2.1.4 Canonical SMILES

CC1(CCC2C(C1)CCC3C2CCC4(C3CCC4C(=O)CN5C=C(C=N5)C#N)C)O

2.1.5 Isomeric SMILES

C[C@]1(CC[C@H]2[C@@H](C1)CC[C@@H]3[C@@H]2CC[C@]4([C@H]3CC[C@@H]4C(=O)CN5C=C(C=N5)C#N)C)O

2.2 Other Identifiers

2.2.1 UNII

7ZW49N180B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

2. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

3. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one

4. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone

5. Sage-217

2.3.2 Depositor-Supplied Synonyms

1. Sage-217

2. 1632051-40-1

3. Zuranolone [inn]

4. Zuranolone [usan]

5. Sge-797

6. Chembl4105630

7. 7zw49n180b

8. S-812217

9. 1-[2-[(3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethyl-2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile

10. Zuranolonesage-217

11. Zuranolone (usan/inn)

12. Unii-7zw49n180b

13. Schembl16189866

14. Dtxsid601128500

15. Glxc-15028

16. Amy27908

17. Ex-a1880

18. Bdbm50258216

19. Who 10896

20. Akos037648887

21. Db15490

22. Ac-35591

23. Bs-15950

24. Hy-103040

25. Cs-0023489

26. D11793

27. D80690

28. A905859

29. 3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-norpregnanolone

30. 3alpha-hydroxy-3beta-methyl-21-(4-cyano-1h-pyrazol-1'-yl)-19-nor-5beta-pregnan-20-one

31. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile

32. 1-(2-((3r,5r,8r,9r,10s,13s,14s,17s)-3-hydroxy-3,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl)-1h-pyrazole-4-carbonitrile;1-[(3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl]-1h-pyrazole-4-carbonitrile

33. 1-(3.alpha.-hydroxy-3.beta.-methyl-20-oxo-19-nor-5.beta.-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

34. 1-(3alpha-hydroxy-3beta-methyl-20-oxo-19-nor-5beta-pregnan-21-yl)-1h-pyrazole-4-carbonitrile

35. 1h-pyrazole-4-carbonitrile, 1-((3.alpha.,5.beta.)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

36. 1h-pyrazole-4-carbonitrile, 1-((3alpha,5beta)-3-hydroxy-3-methyl-20-oxo-19-norpregnan-21-yl)-

2.4 Create Date

2014-12-29

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₃₅N₃O₂
Molecular Weight	409.6 g/mol
XLogP3	4.5
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	3
Exact Mass	409.27292737 g/mol
Monoisotopic Mass	409.27292737 g/mol
Topological Polar Surface Area	78.9 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	746
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

API SUPPLIERS

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

01 Biogen

U.S.A

Biotech Showcase

Not Confirmed

Not Confirmed

10 Sage Therapeutics

U.S.A

Biotech Showcase

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATES SUPPLIERS

01

LinkChem

China

Pharmatech Expo 2025

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

01

BIOGEN INC

U.S.A

BIO Partnering at JPM

Not Confirmed

02

BIOGEN INC

U.S.A

BIO Partnering at JPM

Not Confirmed

03

BIOGEN INC

U.S.A

BIO Partnering at JPM

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

STOCK RECAP #PipelineProspector

ZURANOLONE

Pharmatech Expo 2025

Not Confirmed

Only 10 entries up to this point, click to access all

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

US Exclusivities

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Zuranolone Manufacturers

A Zuranolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zuranolone, including repackagers and relabelers. The FDA regulates Zuranolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zuranolone 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 Zuranolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Zuranolone Suppliers

A Zuranolone supplier is an individual or a company that provides Zuranolone active pharmaceutical ingredient (API) or Zuranolone finished formulations upon request. The Zuranolone suppliers may include Zuranolone API manufacturers, exporters, distributors and traders.

click here to find a list of Zuranolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Zuranolone NDC

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 Zuranolone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Zuranolone API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Zuranolone 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Zuranolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zuranolone NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Zuranolone suppliers with NDC on PharmaCompass.

Zuranolone GMP

Zuranolone 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 Zuranolone 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 Zuranolone GMP manufacturer or Zuranolone GMP API supplier for your needs.

Zuranolone CoA

A Zuranolone CoA (Certificate of Analysis) is a formal document that attests to Zuranolone's compliance with Zuranolone specifications and serves as a tool for batch-level quality control.

Zuranolone CoA mostly includes findings from lab analyses of a specific batch. For each Zuranolone 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.

Zuranolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Zuranolone EP), Zuranolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zuranolone USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

Find Zuranolone manufacturers, exporters & distributors on PharmaCompass

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

5 API Suppliers

2 NDC API

5 Listed Suppliers

DEVELOPMENTS

20 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers

3 FDA Orange Book

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow

1 STOCK RECAP #PipelineProspector

47 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

15 US Patents

3 US Exclusivities

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

01

02

03

04

05

06

07

08

09

10

01

01

02

03

01

02

03

04

05

06

07

08

09

10

Zuranolone Manufacturers

Zuranolone Suppliers

Zuranolone NDC

Finished drug products

Unfinished drugs

Compounded drug products

Zuranolone GMP

Zuranolone CoA

What are you looking for?