DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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01 2Dr. Reddy's Laboratories
02 2Alfred E Tiefenbacher GmbH
03 1NanoAlvand
04 1Pharmathen SA
05 4Accord healthcare
06 1Alkem Laboratories
07 1Alphapharm PTY Ltd
08 2Apotex Inc
09 1Arrow Pharmaceuticals
10 1Ascend Labs
11 1Aurobindo Pharma Limited
12 1Biocon
13 1Bionpharma
14 1Bluepharma
15 1CHEMO
16 1Chartwell Pharmaceuticals llc
17 2Cycle Pharmaceuticals
18 1Deva Holding AS
19 2Devatis AG
20 1Dr Reddy's Laboratories (Australia) Pty Ltd
21 1EZRA VENTURES
22 1Forrester Pharma
23 1Glenmark Pharmaceuticals
24 1HEC Pharm
25 2Hetero Drugs
26 2Intas Pharmaceuticals
27 1JAMP PHARMA
28 1MSN Laboratories
29 2Mepha Pharma
30 1Neuraxpharm
31 2Novartis Pharmaceuticals Australia Pty Limited
32 6Novartis Pharmaceuticals Corporation
33 1Novartis South Africa (Pty) Ltd
34 1ORIFARM GROUP AS
35 1Orchid Pharma
36 1Par Pharmaceutical
37 1Pharmacore Inc
38 1Pharmascience Inc.
39 1Prinston
40 4Sandoz B2B
41 1Standard Chem. & Pharm. Co., Ltd
42 2Sun Pharmaceutical Industries Limited
43 1Taro Pharmaceutical Industries
44 1Tecnimede
45 1Teva Pharma Australia
46 4Teva Pharmaceutical Industries
47 4Viatris
48 1Zydus Pharmaceuticals
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01 1CAB
02 4CAP
03 11CAPSULE
04 23CAPSULE;ORAL
05 12Caps
06 6Capsule
07 1Capsule, hard
08 5Hard Capsule
09 1Hard Gelatin Capsule
10 2TABLET, ORALLY DISINTEGRATING;ORAL
11 8capsule
12 1Blank
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01 3DISCN
02 1EU Approved
03 2EU Dossier Readiness-Q2 2018
04 5Generic
05 1Generic EU CTD
06 1Lead Market Dossiers- Filed
07 1Originator
08 19RX
09 42Blank
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01 1ACH-FINGOLIMOD
02 1AKM Fingolimod
03 1APO-FINGOLIMOD
04 1Danelvin
05 1FILENGIA
06 3FINGOLIMOD
07 18FINGOLIMOD HYDROCHLORIDE
08 2Fingolimod Accord
09 2Fingolimod Devatis
10 1Fingolimod Dr.Reddy's
11 1Fingolimod SUN
12 3Fingolimod Sandoz
13 2Fingolimod Viatris
14 2Fingolimod-Mepha
15 1Fingolimod-Teva
16 1Finkem
17 1Fynod
18 4GILENYA
19 5Gilenya
20 1Glomatin
21 1JAMP FINGOLIMOD
22 1MYLAN-FINGOLIMOD
23 1Myelenea
24 1PMS-FINGOLIMOD
25 1Pharmacor Fingolimod
26 1SANDOZ FINGOLIMOD
27 1TARO-FINGOLIMOD
28 2TASCENSO ODT
29 1TEVA-FINGOLIMOD
30 1Tugivin 0,5 mg
31 12Blank
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01 9Australia
02 10Canada
03 2Germany
04 1Greece
05 4India
06 1Iran
07 1Norway
08 2Portugal
09 5South Africa
10 2Spain
11 12Switzerland
12 1Turkey
13 25USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2021-03-05
Application Number : 208000
Regulatory Info : RX
Registration Country : USA
Regulatory Info : EU Dossier Readiness-Q2 2018
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2018
Registration Country : Germany
Regulatory Info :
Registration Country : Iran
Brand Name : Danelvin
Dosage Form : Hard Gelatin Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
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 : Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Regulatory Info : EU Dossier Readiness-Q2 2018
Registration Country : Germany
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2018
Registration Country : Germany
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-10-28
Application Number : 207991
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-12-18
Application Number : 207993
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-02-28
Application Number : 207983
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2019-12-04
Application Number : 207979
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-06-29
Application Number : 207971
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-06-18
Application Number : 207985
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2021-11-10
Application Number : 207939
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-05-18
Application Number : 207933
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GILENYA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2010-09-21
Application Number : 22527
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GILENYA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.25MG BASE
Packaging :
Approval Date : 2018-05-11
Application Number : 22527
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : FINGOLIMOD
Dosage Form : CAPSULE;ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number : 207965
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : FINGOLIMOD
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date :
Application Number : 207940
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2020-10-14
Application Number : 207994
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FINGOLIMOD HYDROCHLORIDE
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-12-06
Application Number : 207945
Regulatory Info : RX
Registration Country : USA
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