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01 8Alfred E Tiefenbacher GmbH

02 4Granules India Limited

03 1AMN Life Science

04 14Accord healthcare

05 3Aizant Drug Research Solutions Pvt. Ltd.

06 2Alembic Pharmaceuticals Limited

07 2Alphapharm PTY Ltd

08 3Amneal Pharmaceuticals

09 3Apotex Inc

10 4Arrotex Pharmaceuticals

11 2Auro Pharma Inc

12 2Aurobindo Pharma Limited

13 2Aurovitas Spain, Sau

14 11Axunio Pharma Gmbh

15 3Chartwell Pharmaceuticals llc

16 4Cipla

17 1Cipla Medpro South Africa

18 2Dr Reddy's Laboratories (Australia) Pty Ltd

19 26F. Hoffmann-La Roche

20 2Farmoz Sociedade Tecnico Medicinal Sa

21 2Hetero Drugs

22 2Hexal AG

23 2Intas Pharmaceuticals

24 3JAMP PHARMA

25 3Kern Pharma S.L.

26 4Laurus Labs

27 4Legacy Pharma

28 2MANTRA PHARMA INC

29 2MSN Laboratories

30 1Macleods Pharmaceuticals Limited

31 4Mahban Group

32 6Medical Valley

33 3Micro Labs Limited

34 3Newbury Pharmaceuticals AB

35 4Newbury Pharmaceuticals Ab

36 1Nobel Ilac Sanayii Ve Ticaret A.S.

37 2Pharmascience Inc.

38 4Roche Diagnostics GmbH

39 3SCIEGEN PHARMS

40 7STADA Arzneimittel

41 19Sandoz B2B

42 2Tarbis Farma Sl

43 3Tecnimede

44 10Teva Pharmaceutical Industries

45 2Umedica Laboratories

46 9Viatris

47 6Vivanta Generics Sro

48 7Zentiva

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : USA

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number : 212615

Regulatory Info :

Registration Country : USA

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 534MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 801MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 534MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Pirfenidone

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 801MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : USA

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : 801MG

Packaging :

Approval Date :

Application Number : 212615

Regulatory Info :

Registration Country : USA

Granules India

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Pirfenidone

Brand Name : Pirfenidone

Dosage Form : Immediate Release Tablet

Dosage Strength : 267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

12

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info :

Registration Country : India

Pirfenidone

Brand Name : Pirfenidone

Dosage Form : Immediate Release Tablet

Dosage Strength : 801MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Granules India

13

ASCO GU
Not Confirmed
arrow
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date : 2023-08-23

Application Number : 212403

Regulatory Info : DISCN

Registration Country : USA

blank

14

ASCO GU
Not Confirmed
arrow
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : ESBRIET

Dosage Form : CAPSULE;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date : 2014-10-15

Application Number : 22535

Regulatory Info : RX

Registration Country : USA

blank

15

ASCO GU
Not Confirmed
arrow
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : ESBRIET

Dosage Form : TABLET;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date : 2017-01-11

Application Number : 208780

Regulatory Info : RX

Registration Country : USA

blank

16

ASCO GU
Not Confirmed
arrow
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : ESBRIET

Dosage Form : TABLET;ORAL

Dosage Strength : 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2017-01-11

Application Number : 208780

Regulatory Info : DISCN

Registration Country : USA

blank

17

ASCO GU
Not Confirmed
arrow
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : ESBRIET

Dosage Form : TABLET;ORAL

Dosage Strength : 801MG

Packaging :

Approval Date : 2017-01-11

Application Number : 208780

Regulatory Info : RX

Registration Country : USA

blank

18

SCIEGEN PHARMS

Country
ASCO GU
Not Confirmed
arrow

SCIEGEN PHARMS

Country
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date : 2022-08-01

Application Number : 212077

Regulatory Info : RX

Registration Country : USA

blank

19

SCIEGEN PHARMS

Country
ASCO GU
Not Confirmed
arrow

SCIEGEN PHARMS

Country
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : 267MG

Packaging :

Approval Date : 2022-08-01

Application Number : 212078

Regulatory Info : RX

Registration Country : USA

blank

20

SCIEGEN PHARMS

Country
ASCO GU
Not Confirmed
arrow

SCIEGEN PHARMS

Country
arrow
ASCO GU
Not Confirmed

PIRFENIDONE

Brand Name : PIRFENIDONE

Dosage Form : TABLET;ORAL

Dosage Strength : 801MG

Packaging :

Approval Date : 2022-08-01

Application Number : 212078

Regulatory Info : RX

Registration Country : USA

blank