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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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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 2 USDMF, 2 NDC API, 13 Listed Suppliers

13 API Suppliers
2 USDMF
2 NDC API
13 Listed Suppliers

DEVELOPMENTS

38 Drugs in Development

38 Drugs in Development

FINISHED DOSAGE FORMULATIONS

16 FDF Dossiers, 4 FDA Orange Book, 4 Canada, 8 Australia

16 FDF Dossiers
4 FDA Orange Book
4 Canada
8 Australia

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 2 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
2 Annual Reports

MARKET PLACE

1 APIs

marketPlace
1 APIs

PATENTS & EXCLUSIVITIES

8 US Patents, 12 US Exclusivities

patents
8 US Patents
12 US Exclusivities

Metrochem Mavacamten

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

0INTERMEDIATES

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)

8,095,504

Annual Reports (USD Million)

255

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Camzyos, 1642288-47-8, Mavacamten [inn], Mavacamten [usan], Mavacamten [who-dd], Myk-461

Molecular Formula

C₁₅H₁₉N₃O₂

Molecular Weight

273.33 g/mol

InChI Key

RLCLASQCAPXVLM-NSHDSACASA-N

FDA UNII

QX45B99R3J

Mavacamten is under investigation in clinical trial NCT03442764 (A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)).

1 2D Structure

Mavacamten

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

6-[[(1S)-1-phenylethyl]amino]-3-propan-2-yl-1H-pyrimidine-2,4-dione

2.1.2 InChI

InChI=1S/C15H19N3O2/c1-10(2)18-14(19)9-13(17-15(18)20)16-11(3)12-7-5-4-6-8-12/h4-11,16H,1-3H3,(H,17,20)/t11-/m0/s1

2.1.3 InChI Key

RLCLASQCAPXVLM-NSHDSACASA-N

2.1.4 Canonical SMILES

CC(C)N1C(=O)C=C(NC1=O)NC(C)C2=CC=CC=C2

2.1.5 Isomeric SMILES

C[C@@H](C1=CC=CC=C1)NC2=CC(=O)N(C(=O)N2)C(C)C

2.2 Other Identifiers

2.2.1 UNII

QX45B99R3J

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Myk-461

2.3.2 Depositor-Supplied Synonyms

1. Camzyos

2. 1642288-47-8

3. Mavacamten [inn]

4. Mavacamten [usan]

5. Mavacamten [who-dd]

6. Myk-461

7. 6-[[(1s)-1-phenylethyl]amino]-3-propan-2-yl-1h-pyrimidine-2,4-dione

8. Qx45b99r3j

9. Sar-439152

10. (s)-3-isopropyl-6-((1-phenylethyl)amino)pyrimidine-2,4(1h,3h)-dione

11. Sar439152

12. 2,4(1h,3h)-pyrimidinedione, 3-(1-methylethyl)-6-(((1s)-1-phenylethyl)amino)-

13. 2,4(1h,3h)-pyrimidinedione, 3-(1-methylethyl)-6-[[(1s)-1-phenylethyl]amino]-

14. Mavacamten (myk-461)

15. Unii-qx45b99r3j

16. Myk461

17. Chembl4297517

18. Schembl16320785

19. Gtpl11265

20. Ex-a2072

21. Bdbm50575174

22. S8861

23. Who 10492

24. Db14921

25. Myk-461; Mavacamten; Sar439152

26. Sar-439152; Myk-461

27. Hy-109037

28. Cs-0031211

29. E83742

30. (s)-3-isopropyl-6-((1-phenylethyl)amino) Pyrimidine-2,4(1h,3h)-dione

31. (s)-3-isopropyl-6-((1-phenylethyl)amino)pyrimidine-2, 4(1h,3h)-dione

32. (s)-3-isopropyl-6-(1-phenylethylamino)pyrimidine-2,4(1h,3h)-dione

33. 3-(1-methylethyl)-6-[[(1s)-1-phenylethyl]amino]-2,4(1h,3h)-pyrimidinedione

34. 6-(((1s)-1-phenylethyl)amino)-3-(propan-2-yl)-1,2,3,4 Tetrahydropyrimidine-2,4-dione

35. 6-{[(1s)-1-phenylethyl]amino}-3-(propan-2-yl)pyrimidine-2,4(1h,3h)-dione

2.4 Create Date

2016-02-23

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₉N₃O₂
Molecular Weight	273.33 g/mol
XLogP3	2.1
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	273.147726857 g/mol
Monoisotopic Mass	273.147726857 g/mol
Topological Polar Surface Area	61.4 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	411
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	1

4 Drug and Medication Information

4.1 Drug Indication

Treatment of hypertrophic cardiomyopathy

API SUPPLIERS

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

USDMF

01

Moehs Iberica Sl

Spain

CPhI WW Frankfurt

Booth #11.0C6

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

Contact Supplier

Spain

Virtual Booth

Digital Content

Mavacamten

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38462

Submission : 2023-06-22

Status : Active

Type : II

02

Maithri Drugs Private Ltd

India

Antibody Engineering

Not Confirmed

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

01

Metrochem API Private Limited

India

Antibody Engineering

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Mavacamten

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

Moehs Iberica

Spain

CPhI WW Frankfurt

Booth #11.0C6

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

Contact Supplier

Spain

Virtual Booth

Digital Content

Mavacamten

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.

03

Inke S.A

Spain

Antibody Engineering

Not Confirmed

Inke S.A: APIs manufacturing plant.

Contact Supplier

Spain

Virtual Booth

Digital Content

Mavacamten

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.

04

Nuray Chemicals Private Limited

India

Antibody Engineering

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Contact Supplier

India

Virtual Booth

Digital Content

Mavacamten

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.

05

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

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

Contact Supplier

India

Virtual Booth

Digital Content

Mavacamten

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

06

Shandong Chenghui Shuangda Pharmace...

China

CPhI China

Attending

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

Contact Supplier

China

Virtual Booth

Digital Content

Mavacamten

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.

07

Shandong Loncom Pharmaceutical

China

Antibody Engineering

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Mavacamten

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.

Shandong Loncom Pharmaceutical company banner

08

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

Mavacamten

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.