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 12Accord 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 8Axunio Pharma Gmbh
16 3Chartwell Pharmaceuticals llc
17 4Cipla
18 1Cipla Medpro South Africa
19 22F. Hoffmann-La Roche
20 2Farmoz Sociedade Tecnico Medicinal Sa
21 2Hetero Drugs
22 2Intas Pharmaceuticals
23 3JAMP PHARMA
24 3Kern Pharma S.L.
25 4Laurus Labs
26 4Legacy Pharma
27 2MANTRA PHARMA INC
28 2MSN Laboratories
29 1Macleods Pharmaceuticals Limited
30 4Mahban Group
31 3Medical Valley
32 3Micro Labs Limited
33 3Newbury Pharmaceuticals AB
34 2Newbury Pharmaceuticals Ab
35 1Nobel Ilac Sanayii Ve Ticaret A.S.
36 2Pharmascience Inc.
37 4Roche Diagnostics GmbH
38 5STADA Arzneimittel
39 15Sandoz B2B
40 3ScieGen Pharmaceuticals
41 2Tarbis Farma Sl
42 3Tecnimede
43 8Teva Pharmaceutical Industries
44 2Umedica Laboratories
45 6Viatris
46 4Vivanta Generics Sro
47 5Zentiva
01 1CAP
02 2CAPSULE
03 9CAPSULE;ORAL
04 4Capsule
05 80Film Coated Tablet
06 14Film-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 10Blank
01 2Allowed
02 29Approved
03 30Authorized
04 2Cancelled
05 5DISCN
06 8EU Dossier Readiness-Q2 2020
07 1Generic
08 9Marketed
09 5Not Marketed
10 3Originator
11 29Prescription
12 37RX
13 28Blank
01 2ARX-Pirfenidone
02 2AURO-PIRFENIDONE
03 6ESBRIET
04 1ESBRIET 267
05 1ESBRIET 801
06 22Esbriet
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 7Pirfenidone Accord
32 2Pirfenidone Ameda
33 6Pirfenidone Axunio
34 2Pirfenidone Dr.Reddy's
35 3Pirfenidone Kern Pharma
36 5Pirfenidone Newbury
37 9Pirfenidone Sandoz
38 5Pirfenidone Stada
39 2Pirfenidone Teva
40 6Pirfenidone Viatris
41 2Pirfenidone Vivanta
42 1Pirfenidone Zentiva
43 1Pirofibra 267
44 1SANDOZ PIRFENIDONE CAPSULES
45 2SANDOZ PIRFENIDONE TABLETS
46 1Ziadex
47 14Blank
01 10Australia
02 14Canada
03 15Estonia
04 8Germany
05 5India
06 4Iran
07 2Italy
08 14Norway
09 3Portugal
10 4South Africa
11 32Spain
12 29Sweden
13 2Switzerland
14 1Turkey
15 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
