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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 13 USDMF, 1 EU WC, 11 NDC API, 14 Listed Suppliers, $ API Reference Price

25 API Suppliers
13 USDMF
1 EU WC
11 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

6 FDF Dossiers, 1 FDA Orange Book, 1 Europe, 1 Canada, 1 Australia, 2 Listed Dossiers

6 FDF Dossiers
1 FDA Orange Book
1 Europe
1 Canada
1 Australia
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 6 DKSH, 1 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 2 BASF, 1 Clariant, 5 Gangwal Chemicals, 1 Kerry, 3 Lonza Capsugel, 1 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pluviaendo, 1 Qualicaps, 11 Roquette, 8 Seppic, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

14 Solubilizers, 13 Film Formers & Plasticizers, 12 Parenteral, 9 Topical, 9 Fillers, Diluents & Binders, 9 Coating Systems & Additives, 8 Empty Capsules, 8 Thickeners and Stabilizers, 7 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Taste Masking, 2 Direct Compression, 2 Rheology Modifiers, 2 Coloring Agents, 2 Co-Processed Excipients, 2 Chewable & Orodispersible Aids, 1 Soft Gelatin, 1 Controlled & Modified Release, 1 API Stability Enhancers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 44 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
44 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Finished Drug Prices, 5 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
1 Finished Drug Prices
5 Annual Reports

MARKET PLACE

2 APIs, 2 FDF Dossiers

marketPlace
2 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 2 US Exclusivities

patents
3 US Patents
2 US Exclusivities

Inke Tafamidis

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 18,485

MARKET PLACE

API

FDF

7INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS 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)

845,100,487

Annual Reports (USD Million)

9,544

Finished Drug Prices

60 RELATED EXCIPIENT COMPANIES

112EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 594839-88-0, Vyndamax, Fx-1006, 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid, 2-(3,5-dichlorophenyl)-6-benzoxazole carboxylic acid, 8fg9h9d31j

Molecular Formula

C₁₄H₇Cl₂NO₃

Molecular Weight

308.1 g/mol

InChI Key

TXEIIPDJKFWEEC-UHFFFAOYSA-N

FDA UNII

8FG9H9D31J

Tafamidis and tafamidis meglumine (FX-1006A) are benzoxazole derivatives developed by FoldRX. Tafamidis is structurally similar to diflusinal. Tafamidis was granted an EMA market authorisation on 16 November 2011 and FDA approval on 3 May 2019.

1 2D Structure

Tafamidis

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid

2.1.2 InChI

InChI=1S/C14H7Cl2NO3/c15-9-3-8(4-10(16)6-9)13-17-11-2-1-7(14(18)19)5-12(11)20-13/h1-6H,(H,18,19)

2.1.3 InChI Key

TXEIIPDJKFWEEC-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=CC2=C(C=C1C(=O)O)OC(=N2)C3=CC(=CC(=C3)Cl)Cl

2.2 Other Identifiers

2.2.1 UNII

8FG9H9D31J

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Fx 1006a

2. Fx-1006a

3. Fx1006a

4. Tafamidis Meglumine

5. Vyndamax

6. Vyndaqel

2.3.2 Depositor-Supplied Synonyms

1. 594839-88-0

2. Vyndamax

3. Fx-1006

4. 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid

5. 2-(3,5-dichlorophenyl)-6-benzoxazole Carboxylic Acid

6. 8fg9h9d31j

7. Chebi:78538

8. 2-(3,5-dichlorophenyl)benzoxazole-6-carboxylic Acid

9. 2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylic Acid

10. 594839-88-0 (free Acid)

11. Fx1006

12. Mfcd16621109

13. Fx-1005

14. 6-benzoxazolecarboxylic Acid, 2-(3,5-dichlorophenyl)-

15. Tafamidis [usan]

16. Tafamidis [usan:inn]

17. Tafamidisum

18. Unii-8fg9h9d31j

19. 4his

20. Tafamidis-meglumine

21. Vyndamax (tn)

22. 3mi

23. Tafamidis [inn]

24. Tafamidis [jan]

25. Tafamidis [mi]

26. Tafamidis [mart.]

27. Tafamidis [who-dd]

28. Tafamidis (jan/usan/inn)

29. Schembl442508

30. Gtpl8378

31. Tafamidis [orange Book]

32. Chembl2103837

33. Pf-06291826(tafamidis)

34. Dtxsid00208185

35. Hms3741e09

36. Bcp29089

37. Ex-a3575

38. Bdbm50197883

39. S6465

40. Zinc43206271

41. Akos017550076

42. Db11644

43. Vs-0125

44. Ncgc00390731-01

45. 137464-18-7

46. Hy-14852

47. Sy217402

48. Db-072645

49. Ft-0674793

50. A14111

51. C75776

52. D09673

53. 839d880

54. A869196

55. Q519447

56. 2-(3,5-dichloro-phenyl)-benzooxazole-6-carboxylic Acid

57. Z2588039578

58. Discontinued Until Pfizer Approves It For Our Agreement""

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₇Cl₂NO₃
Molecular Weight	308.1 g/mol
XLogP3	4.2
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	2
Exact Mass	306.9802985 g/mol
Monoisotopic Mass	306.9802985 g/mol
Topological Polar Surface Area	63.3 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	371
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
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

Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Tafamidis stabilizes transthyretin tetramers, reducing the amount of monomers available for amyloidogenesis. It has a long duration of action as it is given once daily, and a wide therapeutic window.

5.2 ATC Code

N07XX08

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

N - Nervous system

N07 - Other nervous system drugs

N07X - Other nervous system drugs

N07XX - Other nervous system drugs

N07XX08 - Tafamidis

5.3 Absorption, Distribution and Excretion

Absorption

Tafamidis reaches a C_max of 1430.93ng/mL with a T_max of 1.75h fasted and 4h fed. The AUC of tafamidis is 47,864.31ng\*h/mL.

Route of Elimination

A 20mg oral dose of tafamidis is approximately 59% recovered in the feces, largely as unchanged drug. Approximately 22% of a 20mg oral dose is recovered in the urine, mostly as the glucuronide metabolite.

Volume of Distribution

The apparent volume of distribution at steady state is 18.5L.

Clearance

The oral clearance of tafamidis is 0.263L/h. The apparent total clearance is 0.44L/h.

5.4 Metabolism/Metabolites

Tafamidis is largely not subject to first pass or oxidative metabolism, being 90% unchanged after in in vitro experiments. Preclinical data suggest tafamidis is mainly metabolized through glucuronidation and excreted in bile.

5.5 Biological Half-Life

The half life of tafamidis is 49h.

5.6 Mechanism of Action

Genetic mutations or natural misfolding of transthyretin destabalizes transthyretin tetramers, leading to their dissociation and aggregation in tissues, and disrupting the normal function of these tissues. Tafamidis binds to transthyretin tetramers at the thyroxin binding sites, stabilizing the tetramer, reducing the availability of monomers for amyloidogenesis.

API SUPPLIERS

01

Inke S.A

Spain

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

DDL Conference

Exhibiting

Inke S.A: APIs manufacturing plant.

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Spain

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02

Nuray Chemicals Private Limited

India

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

AES 2024

Not Confirmed

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India

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USDMF

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NDC

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03

FARMAK, a.s

Czech Republic

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

AES 2024

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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Czech Republic

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04

Biophore India Pharmaceuticals Pvt...

India

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

AES 2024

Not Confirmed

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

05

Inabata France S.A.S

France

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

AES 2024

Not Confirmed

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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France

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06

Virupaksha Organics

India

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CPhI WW Frankfurt

Booth #11.0F34

With Virupaksha, you get a quality product with on-time delivery.

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India

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07

HRV Global Life Sciences

India

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CPHI Middle east

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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08

Neuland Laboratories

India

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AES 2024

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Neuland Laboratories- A dedicated 100% API provider.

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09

TAPI Technology & API Services

Israel

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

CPhI WW Frankfurt

Booth #6.1A32

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

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Israel

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10

Nuray Chemicals Private Limited

India

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

AES 2024

Not Confirmed

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

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India

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USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

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NDC API

01

NURAY CHEMICALS PRIVATE LIMITED

India

AES 2024

Not Confirmed

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

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TAFAMIDIS

NDC Package Code : 58159-079

Start Marketing Date : 2020-06-17

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (35kg/35kg)

Marketing Category : BULK INGREDIENT

02

NURAY CHEMICALS PRIVATE LIMITED

India

AES 2024

Not Confirmed

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

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TAFAMIDIS

NDC Package Code : 58159-090

Start Marketing Date : 2022-07-19

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (35kg/35kg)

Marketing Category : BULK INGREDIENT

03

Biophore India Pharmaceuticals Pvt....

India

AES 2024

Not Confirmed

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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TAFAMIDIS

NDC Package Code : 73435-031

Start Marketing Date : 2022-12-21

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

04

Neuland Laboratories Limited

India

AES 2024

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Neuland Laboratories- A dedicated 100% API provider.

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TAFAMIDIS

NDC Package Code : 58032-1031

Start Marketing Date : 2023-03-30

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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05

Aurobindo Pharma Limited

India

U.S.A

AES 2024

Not Confirmed

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Listed Suppliers

01

Inke S.A

Spain

DDL Conference

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Spain

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Tafamidis

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.

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Nuray Chemicals Private Limited

India

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Tafamidis

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.

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FARMAK, a.s

Czech Republic

AES 2024

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About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...

Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingredients (APIs), intermediates and specialized chemicals. The company primarily focuses on exporting its products, with the main markets being the EU, USA, India, Japan and Latin America. Additionally, Farmak offers contract manufacturing and custom synthesis services through its R&D department to support the clients.

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Inabata France S.A.S

France

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Tafamidis

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.

05

Virupaksha Organics

India

CPhI WW Frankfurt

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Tafamidis

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.

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HRV Global Life Sciences

India

CPHI Middle east

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Tafamidis

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.

07

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

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

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Tafamidis

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.

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08

Aurobindo Pharma Limited

India

AES 2024

Not Confirmed

09

Glenmark Pharmaceuticals

India

AES 2024

Not Confirmed

10

Raghava Life Sciences

India

AES 2024

Not Confirmed

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API Reference Price

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