DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 8Alfred E Tiefenbacher GmbH
03 4Granules India Limited
04 1AMN Life Science
05 7Accord healthcare
06 3Aizant Drug Research Solutions Pvt. Ltd.
07 2Alembic Pharmaceuticals Limited
08 2Alphapharm PTY Ltd
09 3Amneal Pharmaceuticals
10 3Apotex Inc
11 4Arrotex Pharmaceuticals
12 2Auro Pharma Inc
13 2Aurobindo Pharma Limited
14 2Aurovitas Spain, Sau
15 3Axunio Pharma GmbH
16 5Axunio Pharma Gmbh
17 3Chartwell Pharmaceuticals llc
18 4Cipla
19 1Cipla Medpro South Africa
20 15F. Hoffmann-La Roche
21 2Farmoz Sociedade Tecnico Medicinal Sa
22 2Hetero Drugs
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 3Medical Valley
33 3Micro Labs Limited
34 2Newbury Pharmaceuticals Ab
35 1Nobel Ilac Sanayii Ve Ticaret A.S.
36 2Pharmascience Inc.
37 4Roche Diagnostics GmbH
38 5STADA Arzneimittel
39 12Sandoz B2B
40 3ScieGen Pharmaceuticals
41 2Tarbis Farma Sl
42 3Tecnimede
43 6Teva Pharmaceutical Industries
44 2Umedica Laboratories
45 3Viatris
46 4Vivanta Generics Sro
47 4Zentiva
01 1CAP
02 2CAPSULE
03 9CAPSULE;ORAL
04 1Capsule
05 2Capsule, hard
06 68Film Coated Tablet
07 6Hard Capsule
08 2Immediate Release Tablet
09 1Pirfenidone 267Mg 252 Unita' Oral Use
10 1Pirfenidone 267Mg 63 Combined Oral Use
11 2TAB
12 12TABLET
13 36TABLET;ORAL
14 1Tab
15 7Tablet
16 3Tablet, film-coated
17 10Blank
01 2Allowed
02 29Approved
03 30Authorized
04 2Cancelled
05 5DISCN
06 8EU Dossier Readiness-Q2 2020
07 1Generic
08 3Originator
09 14Prescription
10 37RX
11 33Blank
01 2ARX-Pirfenidone
02 2AURO-PIRFENIDONE
03 6ESBRIET
04 1ESBRIET 267
05 1ESBRIET 801
06 15Esbriet
07 3JAMP PIRFENIDONE
08 2M-PIRFENIDONE
09 41PIRFENIDONE
10 1PIRFENIDONE 200
11 1PIRFENIDONE 267
12 1PIRFENIDONE 534
13 1PIRFENIDONE 801
14 2PMS-PIRFENIDONE
15 2Pirfenidet
16 2Pirfenidon Cipla
17 3Pirfenidon Medical Valley
18 2Pirfenidon Teva
19 2Pirfenidon Zentiva
20 2Pirfenidona Accord
21 2Pirfenidona Aurovitas
22 2Pirfenidona Axunio
23 2Pirfenidona Cipla
24 2Pirfenidona Tarbis
25 2Pirfenidona Tecnigen
26 2Pirfenidona Teva
27 2Pirfenidona Umedica
28 2Pirfenidona Vivanta
29 2Pirfenidona Zentiva
30 2Pirfenidone
31 2Pirfenidone Accord
32 2Pirfenidone Ameda
33 6Pirfenidone Axunio
34 2Pirfenidone Dr.Reddy's
35 3Pirfenidone Kern Pharma
36 2Pirfenidone Newbury
37 6Pirfenidone Sandoz
38 5Pirfenidone Stada
39 3Pirfenidone Viatris
40 2Pirfenidone Vivanta
41 1Pirofibra 267
42 1SANDOZ PIRFENIDONE CAPSULES
43 2SANDOZ PIRFENIDONE TABLETS
44 1Ziadex
45 14Blank
01 10Australia
02 14Canada
03 8Germany
04 5India
05 4Iran
06 2Italy
07 5Norway
08 3Portugal
09 4South Africa
10 32Spain
11 29Sweden
12 2Switzerland
13 1Turkey
14 45USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : Australia
Brand Name : Pirfenidone Dr.Reddy's
Dosage Form :
Dosage Strength :
Packaging : 90
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 267MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : USA
Brand Name : PIRFENIDONE
Dosage Form : TABLET;ORAL
Dosage Strength : 267MG
Packaging :
Approval Date :
Application Number : 212615
Regulatory Info :
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : Australia
Brand Name : Pirfenidone Dr.Reddy's
Dosage Form :
Dosage Strength :
Packaging : 90
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 267MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2020
Registration Country : Germany
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
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : USA
Brand Name : PIRFENIDONE
Dosage Form : TABLET;ORAL
Dosage Strength : 801MG
Packaging :
Approval Date :
Application Number : 212615
Regulatory Info :
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Pirfenidone
Dosage Form : Immediate Release Tablet
Dosage Strength : 267MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Pirfenidone
Dosage Form : Immediate Release Tablet
Dosage Strength : 801MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
