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 3Mankind Pharma
04 3Accord healthcare
05 1Adalvo
06 3Alkem Laboratories
07 21Amgen Inc
08 3Amneal Pharmaceuticals
09 2Anabiosis S.A.
10 3Annora Pharma
11 1Apotex Inc
12 4Auro Pharma Inc
13 3Aurobindo Pharma Limited
14 1Avansor Pharma Oy
15 5Celgene Corporation
16 4Glenmark Pharmaceuticals
17 3Intas Pharmaceuticals
18 4JAMP PHARMA
19 2Krka
20 1MINT PHARMACEUTICALS INC
21 3MSN Laboratories
22 3Macleods Pharmaceuticals Limited
23 1Noucor
24 1Pharmascience Inc.
25 7STADA Arzneimittel
26 7Sandoz B2B
27 3Shilpa Medicare
28 1Tarbis Farma Sl
29 3Tecnimede
30 5Teva Pharmaceutical Industries
31 6Torrent Pharmaceuticals Limited
32 3Unichem Pharmaceuticals USA, Inc
33 5Zentiva
34 3Zydus Pharmaceuticals
01 1Antic-calc Tablet, Film Coated
02 3Coated Tablet
03 1FCT
04 41Film Coated Tablet
05 3Film Coated Tablet
06 3Oral Solid Dosage Form
07 20TABLET
08 1TABLET, EXTENDED RELEASE;ORAL
09 1TABLET;EXTENDED RELEASE
10 50TABLET;ORAL
11 3Tablet
12 3Blank
01 2Allowed
02 23Approved
03 7Authorized
04 24DISCN
05 6EU Dossier Readiness-Q3 2020
06 3Lead Market Dossiers- Filed
07 1Originator
08 20Prescription
09 19RX
10 25Blank
01 1APO-APREMILAST
02 42APREMILAST
03 4AURO-APREMILAST
04 3Apremilast Accord
05 2Apremilast Anabiosis
06 1Apremilast Avansor
07 2Apremilast Krka
08 1Apremilast Noucor
09 3Apremilast Sandoz
10 3Apremilast Stada
11 2Apremilast Stada Arzneimittel Ag
12 2Apremilast Stada Nordic
13 1Apremilast Tarbis
14 2Apremilast Teva
15 2Apremilast Zentiva
16 1GLN-APREMILAST
17 4JAMP APREMILAST
18 1MINT-APREMILAST
19 12OTEZLA
20 2OTEZLA XR
21 11Otezla
22 1Otezla 30mg
23 1PMS-APREMILAST
24 1Phomilot
25 4SANDOZ APREMILAST
26 21Blank
01 2Australia
02 20Canada
03 3Czech Republic
04 6Germany
05 9India
06 2Norway
07 3Portugal
08 1South Africa
09 7Spain
10 23Sweden
11 2Switzerland
12 52USA
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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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
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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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
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 :
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
