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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

51 API Suppliers, 22 USDMF, 7 EU WC, 6 KDMF, 11 NDC API, 39 Listed Suppliers, $ API Reference Price

51 API Suppliers
22 USDMF
7 EU WC
6 KDMF
11 NDC API
39 Listed Suppliers
$ API Reference Price

INTERMEDIATES

9 Intermediates Suppliers

9 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

17 FDF Dossiers, 6 Europe, 4 South Africa, 7 Listed Dossiers

17 FDF Dossiers
6 Europe
4 South Africa
7 Listed Dossiers

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 43 NEWS #PharmaBuzz

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4 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
43 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices, 3 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
6 Finished Drug Prices
3 Annual Reports

MARKET PLACE

14 APIs

marketPlace
14 APIs

DRL Sacubitril Valsartan

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

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)

2,147,483,647

Annual Reports (USD Million)

14,227

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Sacubitril valsartan sodium hydrate, Sacubitril mixture with valsartan, Wb8ft61183, Lcz 696, Sacubitril valsartan sodium hydrate (jan), Sacubitril valsartan sodium hydrate [jan]

Molecular Formula

C₉₆H₁₂₀N₁₂Na₆O₂₁

Molecular Weight

1916.0 g/mol

InChI Key

ZASXKEGREHRXDL-CAWNUZPDSA-H

FDA UNII

WB8FT61183

Sacubitril/Valsartan is a combination of sacubitril and valsartan with natriuretic and anti-hypertensive properties. Upon administration, sacubitril is metabolized by esterases to its active metabolite, LBQ657 (sacubitrilat), which inhibits neprilysin, a neutral endopeptidase that cleaves natriuretic peptides such as atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and c-type natriuretic peptide (CNP), as well as certain vasoconstricting peptides including as angiotensin I and II, and endothelin-1. Inhibition of neprilysin leads to increased concentrations of endogenous natriuretic peptides, which function to activate downstream receptors that promote vasodilation, natriuresis and diuresis, while simultaneously increasing the concentration of vasoconstricting peptides such as angiotensin II. Co-administration with valsartan, an angiotensin II receptor blocker, prevents the vasoconstrictive effects of neprilysin inhibition and promotes a decrease in vascular resistance and blood pressure.

1 2D Structure

Sacubitril-Valsartan

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

hexasodium;4-[[(2S,4R)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate;(2S)-3-methyl-2-[pentanoyl-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]amino]butanoate;pentahydrate

2.1.2 InChI

InChI=1S/2C24H29N5O3.2C24H29NO5.6Na.5H2O/c2*1-4-5-10-21(30)29(22(16(2)3)24(31)32)15-17-11-13-18(14-12-17)19-8-6-7-9-20(19)23-25-27-28-26-23;2*1-3-30-24(29)17(2)15-21(25-22(26)13-14-23(27)28)16-18-9-11-20(12-10-18)19-7-5-4-6-8-19;;;;;;;;;;;/h2*6-9,11-14,16,22H,4-5,10,15H2,1-3H3,(H2,25,26,27,28,31,32);2*4-12,17,21H,3,13-16H2,1-2H3,(H,25,26)(H,27,28);;;;;;;5*1H2/q;;;;6*+1;;;;;/p-6/t2*22-;2*17-,21+;;;;;;;;;;;/m0011.........../s1

2.1.3 InChI Key

ZASXKEGREHRXDL-CAWNUZPDSA-H

2.1.4 Canonical SMILES

CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)C(C(C)C)C(=O)[O-].CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)C(C(C)C)C(=O)[O-].CCOC(=O)C(C)CC(CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].CCOC(=O)C(C)CC(CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]

2.1.5 Isomeric SMILES

CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)[C@@H](C(C)C)C(=O)[O-].CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NN=N[N-]3)[C@@H](C(C)C)C(=O)[O-].CCOC(=O)[C@H](C)C[C@@H](CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].CCOC(=O)[C@H](C)C[C@@H](CC1=CC=C(C=C1)C2=CC=CC=C2)NC(=O)CCC(=O)[O-].O.O.O.O.O.[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]

2.2 Other Identifiers

2.2.1 UNII

WB8FT61183

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate

2. Lcz 696

3. Lcz-696

4. Lcz696

5. Sacubitril And Valsartan Drug Combination

6. Sacubitril And Valsartan Sodium Anhydrous Drug Combination

7. Sacubitril And Valsartan Sodium Hydrate Drug Combination

8. Sacubitril Valsartan Drug Combination

9. Sacubitril Valsartan Sodium Anhydrous

10. Sacubitril Valsartan Sodium Hydrate

11. Sacubitril-valsartan

12. Sacubitril-valsartan Sodium Anhydrous Drug Combination

13. Sacubitril-valsartan Sodium Hydrate Drug Combination

14. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate

2.3.2 Depositor-Supplied Synonyms

1. Sacubitril Valsartan Sodium Hydrate

2. Sacubitril Mixture With Valsartan

3. Wb8ft61183

4. Lcz 696

5. Sacubitril Valsartan Sodium Hydrate (jan)

6. Sacubitril Valsartan Sodium Hydrate [jan]

7. Entresto (tn)

8. Unii-wb8ft61183

9. Valsartan Mixture With Ahu-377

10. Ex-a2849

11. Mfcd29477717

12. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate

13. Ac-29037

14. Sucabitril Valsartan Sodium Hydrate

15. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate

16. D10226

17. Valsartan Ahu-377 Sodium Hemipentahydrate

18. Q27292546

19. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With .alpha.-ethyl (.alpha.r,.gamma.s)-.gamma.-((3-carboxy-1-oxopropyl)amino)-.alpha.-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)

20. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With Alpha-ethyl(alphar,gammas)-gamma-((3-carboxy-1-oxopropyl)amino)-alpha-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)

2.4 Create Date

2013-05-27

3 Chemical and Physical Properties

Molecular Formula	C₉₆H₁₂₀N₁₂Na₆O₂₁
Molecular Weight	1916.0 g/mol
Hydrogen Bond Donor Count	7
Hydrogen Bond Acceptor Count	29
Rotatable Bond Count	40
Exact Mass	1915.8110694 g/mol
Monoisotopic Mass	1914.8077146 g/mol
Topological Polar Surface Area	396 Å²
Heavy Atom Count	135
Formal Charge	0
Complexity	1140
Isotope Atom Count	0
Defined Atom Stereocenter Count	6
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	15

4 Drug and Medication Information

4.1 Drug Indication

Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Angiotensin Receptor Antagonists

Agents that antagonize ANGIOTENSIN RECEPTORS. Many drugs in this class specifically target the ANGIOTENSIN TYPE 1 RECEPTOR. (See all compounds classified as Angiotensin Receptor Antagonists.)

5.2 ATC Code

C09DX04

API SUPPLIERS

01

Dr. Reddy's Laboratories

India

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

Medlab Asia & Asia Health

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Polpharma

Poland

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03

Faran Shimi Pharmaceutical

Iran

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

Medlab Asia & Asia Health

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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Iran

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04

Virupaksha Organics

India

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CPhI WW Frankfurt

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05

Ami Lifesciences Private Limited

India

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Medlab Asia & Asia Health

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AMI Lifesciences is Driven by Chemistry. Powered by People.

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06

Aptra Synthesis

India

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07

HRV Global Life Sciences

India

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

CPHI Middle east

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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08

Octavius Pharma Pvt. Ltd

India

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MAGHREB PHARMA

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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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09

Zhuhai Rundu Pharmaceutical

China

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Medlab Asia & Asia Health

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10

HONOUR LAB LTD

India

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Medlab Asia & Asia Health

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USDMF

01

Dr Reddys Laboratories Ltd

India

CPHI Middle east

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

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Sacubitril/valsartan

GDUFA

DMF Review : Complete

Rev. Date : 2017-12-22

Pay. Date : 2017-11-08

DMF Number : 31574

Submission : 2017-08-29

Status : Active

Type : II

02

Zaklady Farmaceutyczne Polpharma Sa

Poland

CPHI Middle east

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Poland

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Sacubitril/valsartan Complex

GDUFA

DMF Review : Complete

Rev. Date : 2018-09-04

Pay. Date : 2017-12-20

DMF Number : 32337

Submission : 2017-12-21

Status : Active

Type : II

03

Ami Lifesciences Private Ltd

India

CPHI Middle east

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Sacubitril Valsartan Trisodium Salt Hemipentah...

GDUFA

DMF Review : N/A

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Pay. Date :

DMF Number : 37994

Submission : 2023-03-09

Status : Active

Type : II

04

Teva Pharmaceutical Industries Ltd

Israel

CPhI WW Frankfurt

Booth #6.1A32

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

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Sacubitril/valsartan

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DMF Review : Complete

Rev. Date : 2019-04-12

Pay. Date : 2018-12-20

DMF Number : 33457

Submission : 2019-02-28

Status : Active

Type : II

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10

Msn Life Sciences Private Ltd

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Aurobindo Pharma Limited

India

Antibody Engineering

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Not Confirmed

10

zhejiang jiuzhou pharmaceutical Co....

China

Antibody Engineering

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Listed Suppliers

01

Dr. Reddy's Laboratories

India

Medlab Asia & Asia Health

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Sacubitril-Valsartan

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

02

Polpharma

Poland

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Sacubitril-Valsartan

About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.

03

Faran Shimi Pharmaceutical

Iran

Medlab Asia & Asia Health

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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Iran

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Sacubitril-Valsartan

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.

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04

Virupaksha Organics

India

CPhI WW Frankfurt

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Sacubitril-Valsartan

About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...

Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the Hyderabad-based company has grown from a single manufacturing unit to four, employing over 1,000 people. The manufacturing units are situated in Kazipally, Pashamylaram, Humnabad and Gandhi Nagar. Virupaksha's manufacturing facility holds FDA approval, reflecting its adherence to stringent standards. With a customer base exceeding 300 and a presence spanning over 70 countries, Virupaksha has established itself as a reputable global player in its field.

05

Ami Lifesciences Private Limited

India

Medlab Asia & Asia Health

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Sacubitril-Valsartan

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.

06

Aptra Synthesis

India

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Sacubitril-Valsartan

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.

07

HRV Global Life Sciences

India

CPHI Middle east

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Sacubitril-Valsartan

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.

08

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Sacubitril And Valsartan

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.

09

Amara Labs

India

Medlab Asia & Asia Health

Not Confirmed

10

Divis Laboratories

India

Medlab Asia & Asia Health

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

China

Medlab Asia & Asia Health

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Europe

01

Novartis Pharma Schweiz AG

Switzerland

Switzerland

Medlab Asia & Asia Health

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South Africa

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Listed Dossiers

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DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.