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List of All Manufacturers & Suppliers of Pirfenidone Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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01 8Alfred E Tiefenbacher GmbH

02 4Granules India Limited

03 1AMN Life Science

04 3Accord healthcare

05 3Aizant Drug Research Solutions Pvt. Ltd.

06 2Alembic Pharmaceuticals Limited

07 2Alphapharm PTY Ltd

08 3Amneal Pharmaceuticals

09 3Apotex Inc

10 2Arrotex Pharmaceuticals

11 2Auro Pharma Inc

12 3Axunio Pharma GmbH

13 3Chartwell Pharmaceuticals llc

14 2Dr Reddy's Laboratories (Australia) Pty Ltd

15 12F. Hoffmann-La Roche

16 4Genentech

17 2Hetero Drugs

18 2Intas Pharmaceuticals

19 3JAMP PHARMA

20 4Laurus Labs

21 2MSN Laboratories

22 3Micro Labs Limited

23 1Nobel Ilac Sanayii Ve Ticaret A.S.

24 2Pharmascience Inc.

25 8Sandoz B2B

26 3ScieGen Pharmaceuticals

27 3Tecnimede

28 2Teva Pharmaceutical Industries

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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 : ROW, US

Registration Country : India

Pirfenidone

Brand Name :

Dosage Form : Immediate Release Tablet

Dosage Strength : 1267MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

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 : ROW, US

Registration Country : India

Pirfenidone

Brand Name :

Dosage Form : Immediate Release Tablet

Dosage Strength : 801MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

13

AAPS 2024
Not Confirmed
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AAPS 2024
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

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14

AAPS 2024
Not Confirmed
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AAPS 2024
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

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15

AAPS 2024
Not Confirmed
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AAPS 2024
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

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16

AAPS 2024
Not Confirmed
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AAPS 2024
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

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17

AAPS 2024
Not Confirmed
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AAPS 2024
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

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18

AAPS 2024
Not Confirmed
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AAPS 2024
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

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19

AAPS 2024
Not Confirmed
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AAPS 2024
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

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20

AAPS 2024
Not Confirmed
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AAPS 2024
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

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