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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 2 USDMF, 5 KDMF, 14 Listed Suppliers, $ API Reference Price

14 API Suppliers
2 USDMF
5 KDMF
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 Listed Dossiers

1 FDF Dossiers
1 Listed Dossiers

DIGITAL CONTENT

5 NEWS #PharmaBuzz

media
5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Annual Reports

globalSalesInformation
4 Annual Reports

MARKET PLACE

3 APIs

marketPlace
3 APIs

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

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API REF. PRICE (USD/KG)

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)

986

Finished Drug Prices

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Chemistry

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Also known as: 1138245-21-2, Mirogabalin besilate, Mirogabalin besylate [usan], 01f4frp8yl, 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid, Mirogabalin besilate (jan)

Molecular Formula

C₁₈H₂₅NO₅S

Molecular Weight

367.5 g/mol

InChI Key

OKJXJRVWXYRSAN-TXULWXBWSA-N

FDA UNII

01F4FRP8YL

1 2D Structure

Mirogabalin Besylate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[(1R,5S,6S)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid

2.1.2 InChI

InChI=1S/C12H19NO2.C6H6O3S/c1-2-8-3-9-5-12(7-13,6-11(14)15)10(9)4-8;7-10(8,9)6-4-2-1-3-5-6/h4,9-10H,2-3,5-7,13H2,1H3,(H,14,15);1-5H,(H,7,8,9)/t9-,10-,12-;/m1./s1

2.1.3 InChI Key

OKJXJRVWXYRSAN-TXULWXBWSA-N

2.1.4 Canonical SMILES

CCC1=CC2C(C1)CC2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O

2.1.5 Isomeric SMILES

CCC1=C[C@@H]2[C@H](C1)C[C@@]2(CC(=O)O)CN.C1=CC=C(C=C1)S(=O)(=O)O

2.2 Other Identifiers

2.2.1 UNII

01F4FRP8YL

2.3 Synonyms

2.3.1 Depositor-Supplied Synonyms

1. 1138245-21-2

2. Mirogabalin Besilate

3. Mirogabalin Besylate [usan]

4. 01f4frp8yl

5. 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic Acid;benzenesulfonic Acid

6. Mirogabalin Besilate (jan)

7. Mirogabalin Besylate (usan)

8. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Compound With Benzenesulfonic Acid (1:1)

9. Bicyclo(3.2.0)hept-3-ene-6-acetic Acid, 6-(aminomethyl)-3-ethyl-, (1r,5s,6s)-, Benzenesulfonate (1:1)

10. Mirogabalin Besilate [jan]

11. Unii-01f4frp8yl

12. Mirogabalin Besilate [who-dd]

13. Schembl1883872

14. Chembl3545257

15. Amy16760

16. Ex-a2817

17. Mfcd31631215

18. Ac-30336

19. Hy-108006

20. Cs-0027136

21. D10790

22. A901402

23. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)acetic Acid Besylate

24. 2-((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl)aceticacidbesylate

25. ((1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo(3.2.0)hept-3-en-6-yl)acetic Acid Monobenzenesulfonate

26. [(1r,5s,6s)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic Acid Benzenesulfonate;

2.4 Create Date

2014-10-20

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₅NO₅S
Molecular Weight	367.5 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	367.14534407 g/mol
Monoisotopic Mass	367.14534407 g/mol
Topological Polar Surface Area	126 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	494
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

API SUPPLIERS

01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Ami Lifesciences Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

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USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

Aptra Synthesis

India

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Medlab Asia & Asia Health

Not Confirmed

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05

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east

Attending

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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06

Lee Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

07

Tianjin Hankang Pharmaceutical Bio...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

08

Sichuan Qingmu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

09

Prajna Generics

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

10

Zhejiang Tianyu Pharmaceutical Co....

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

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USDMF

01

Ami Lifesciences Private Ltd

India

Antibody Engineering

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

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Mirogabalin Besylate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39342

Submission : 2023-12-29

Status : Active

Type : II

02

Lee Pharma Ltd

India

Antibody Engineering

Not Confirmed

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KDMF

01

Daiichi Sankyo

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

02

Lee Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

03

Lee Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

04

Lee Pharma

India

Pharma, Lab & Chemical Expo

Not Confirmed

05

Sekisui Medical Co. Ltd

Japan

Pharma, Lab & Chemical Expo

Not Confirmed

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Listed Suppliers

01

Metrochem API Private Limited

India

Medlab Asia & Asia Health

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Contact Supplier

India

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Mirogabalin Besylate

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer

02

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Mirogabalin Besylate

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale

03

Ami Lifesciences Private Limited

India

Medlab Asia & Asia Health

Not Confirmed

AMI Lifesciences is Driven by Chemistry. Powered by People.

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Mirogabalin Besylate

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.

04

Aptra Synthesis

India

Medlab Asia & Asia Health

Not Confirmed

Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

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Mirogabalin Besilate

About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...

Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to GMP standards. We take great pride in producing top-notch intermediates through our fully backward-integrated process. Aptra Synthesis Private Limited (ASPL) stands as one of the rapidly emerging manufacturers of Active Pharmaceutical Ingredients (APIs), Pellets (Semi-finished Formulations), and Intermediates.

05

HRV Global Life Sciences

India

CPHI Middle east

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Mirogabalin Besylate

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

06

Ceyone Life Sciences

India

Medlab Asia & Asia Health

Not Confirmed

07

Lee Pharma

India

Medlab Asia & Asia Health

Not Confirmed

08

Prajna Generics

India

Medlab Asia & Asia Health

Not Confirmed

09

Shanghai Hope Chem

China

Medlab Asia & Asia Health

Not Confirmed

10

Sichuan Qingmu Pharmaceutical

China

Medlab Asia & Asia Health

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API Reference Price

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