DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 6Dr. Reddy's Laboratories
02 6Alfred E Tiefenbacher GmbH
03 3Alkem Laboratories
04 11Amgen Inc
05 3Amneal Pharmaceuticals
06 3Annora Pharma
07 1Apotex Inc
08 4Auro Pharma Inc
09 3Aurobindo Pharma Limited
10 7Celgene Corporation
11 3Farmaprojects S.A.U
12 4Glenmark Pharmaceuticals
13 3Intas Pharmaceuticals
14 4JAMP PHARMA
15 1Key Oncologics
16 1MINT PHARMACEUTICALS INC
17 3Macleods Pharmaceuticals Limited
18 3Mankind Pharma
19 1Pharmascience Inc.
20 4Sandoz B2B
21 3Shilpa Medicare
22 3Tecnimede
23 3Teva Pharmaceutical Industries
24 3Torrent Pharmaceuticals Limited
25 3Unichem Pharmaceuticals USA, Inc
26 3Zentiva
27 3Zydus Pharmaceuticals
01 1Antic-calc Tablet, Film Coated
02 3Coated Tablet
03 2FCT
04 2FILMDRAGERAD TABLETT
05 12Film Coated Tablet
06 3Film Coated Tablet
07 1Film-Coated Tablets
08 3Oral Solid Dosage Form
09 20TABLET
10 42TABLET;ORAL
11 3Tablet
12 3Blank
01 15DISCN
02 6EU Dossier Readiness-Q3 2020
03 1Generic
04 3Lead Market Dossiers- Filed
05 1Originator
06 21RX
07 48Blank
01 1APO-APREMILAST
02 36APREMILAST
03 4AURO-APREMILAST
04 1GLN-APREMILAST
05 4JAMP APREMILAST
06 1MINT-APREMILAST
07 10OTEZLA
08 6Otezla
09 1Otezla 30 mg
10 1Otezla 30mg
11 1Otezla starter pack
12 1PMS-APREMILAST
13 4SANDOZ APREMILAST
14 24Blank
01 2Australia
02 20Canada
03 3Czech Republic
04 6Germany
05 9India
06 2Norway
07 3Portugal
08 2South Africa
09 3Spain
10 2Sweden
11 1Switzerland
12 42USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-07-14
Application Number : 211756
Regulatory Info : DISCN
Registration Country : USA
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-07-14
Application Number : 211756
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2023-07-14
Application Number : 211756
Regulatory Info : DISCN
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2020
Registration Country : Germany
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2021-09-21
Application Number : 211761
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2021-09-21
Application Number : 211761
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2021-09-21
Application Number : 211761
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2014-03-21
Application Number : 205437
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2014-03-21
Application Number : 205437
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2014-03-21
Application Number : 205437
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-07-19
Application Number : 211716
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-07-19
Application Number : 211716
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2023-07-19
Application Number : 211716
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 206088
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number : 206088
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : OTEZLA
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number : 206088
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-10-16
Application Number : 211674
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2023-10-16
Application Number : 211674
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2023-10-16
Application Number : 211674
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2024-02-07
Application Number : 211734
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date : 2024-02-07
Application Number : 211734
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : APREMILAST
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date : 2024-02-07
Application Number : 211734
Regulatory Info : RX
Registration Country : USA
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