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01 4ALFRED E TIEFENBACHER GmbH & Co KG

02 2Accord Healthcare B.V.

03 3Accord Healthcare BV

04 2Accord Healthcare Bv

05 2Accord Healthcare Slu

06 2Aurovitas Spain, Sau

07 8Axunio Pharma Gmbh

08 2Cipla Europe

09 2Cipla Europe Nv

10 2Farmoz Sociedade Tecnico Medicinal Sa

11 3Kern Pharma Sl

12 3Medical Valley Invest Ab

13 3Newbury Pharmaceuticals AB

14 2Newbury Pharmaceuticals Ab

15 1Nobel Ilac Sanayii Ve Ticaret A.S.

16 2ROCHE REGISTRATION LTD

17 2Roche Pharma (Switzerland) Ag

18 5Roche Registration GmbH

19 12Roche Registration Gmbh

20 3Sandoz - Copenhagen

21 2Sandoz A/S

22 2Sandoz Pharmaceuticals Sa

23 2Stada Pharmaceuticals Ag

24 3Stada Sl Laboratory

25 2Tarbis Farma Sl

26 4Teva Gmbh

27 2Teva Pharma Slu

28 2Umedica Netherlands Bv

29 6Viatris Limited

30 4Vivanta Generics Sro

31 1Zentiva K.S.

32 4Zentiva Ks

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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 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

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 : 534MG

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 : 801MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Esbriet

Dosage Form : Pirfenidone 267Mg 63 Combined Oral Use

Dosage Strength : 63 cps 267 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Esbriet

Dosage Form : Pirfenidone 267Mg 252 Unita' Oral Use

Dosage Strength : 252 cps 267 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Esbriet

Dosage Form : Film Coated Tablet

Dosage Strength : 267mg

Packaging :

Approval Date : 24/04/2017

Application Number : 20160423000019

Regulatory Info : Approved

Registration Country : Sweden

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Esbriet

Dosage Form : Capsule

Dosage Strength : 267mg

Packaging :

Approval Date : 28/02/2011

Application Number : 20100428000010

Regulatory Info : Approved

Registration Country : Sweden

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Esbriet

Dosage Form : Film Coated Tablet

Dosage Strength : 534mg

Packaging :

Approval Date : 24/04/2017

Application Number : 20160423000026

Regulatory Info : Approved

Registration Country : Sweden

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

Pirfenidone

Brand Name : Ziadex

Dosage Form : Film Coated Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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