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01 1Orion Corporation
02 3Dr. Reddy's Laboratories
03 2Alfred E Tiefenbacher GmbH
04 1NanoAlvand
05 2Pharmathen SA
06 1Towa Pharmaceutical
07 5Accord healthcare
08 1Alkem Laboratories
09 1Alphapharm PTY Ltd
10 1Amarox Pharma Bv
11 1Apotex Inc
12 2Aristo Pharma GmbH
13 1Arrow Pharmaceuticals
14 1Ascend Labs
15 1Aurobindo Pharma Limited
16 1Aurovitas Spain, Sau
17 1Avansor Pharma Oy
18 2Bausch Health
19 2Biocon
20 1Bionpharma
21 1Bluefish Pharmaceuticals AB
22 1Bluepharma
23 1Chartwell Pharmaceuticals llc
24 1Combix Laboratories Slu
25 2Cycle Pharmaceuticals
26 3Deva Holding AS
27 2Devatis AG
28 1Dr Reddy's Laboratories (Australia) Pty Ltd
29 1EZRA VENTURES
30 1Exeltis
31 1Forrester Pharma
32 1Fresenius Kabi AB Brunna
33 3Glenmark Pharmaceuticals
34 2HEC Pharm
35 2Hetero Drugs
36 2Intas Pharmaceuticals
37 1Intas Third Party Sales 2005 Sl
38 1JAMP PHARMA
39 1Kern Pharma S.L.
40 1Koanaa Healthcare Gmbh
41 2Krka
42 1LABORATORIOS NORMON SA
43 1Lupin Europe Ltd. GB
44 1Lupin Ltd
45 1MEDOCHEMIE LTD
46 1MSN Laboratories
47 1Medical Valley
48 2Mepha Pharma
49 2Neuraxpharm
50 3Novartis Pharmaceuticals Australia Pty Limited
51 9Novartis Pharmaceuticals Corporation
52 1Novartis South Africa (Pty) Ltd
53 1ORIFARM GROUP AS
54 1Orchid Pharma
55 1Par Pharmaceutical
56 1Pensa Pharma
57 1Pharmacore Inc
58 1Pharmascience Inc.
59 1Prinston
60 1Reig Jofre
61 2STADA Arzneimittel
62 7Sandoz B2B
63 1Spirig Healthcare
64 1Standard Chem. & Pharm. Co., Ltd
65 3Sun Pharmaceutical Industries Limited
66 2Swan Pond Investments Limited
67 2Tarbis Farma Sl
68 1Taro Pharmaceutical Industries
69 2Tecnimede
70 1Teva Pharma Australia
71 8Teva Pharmaceutical Industries
72 2Tillomed Laboratories Ltd
73 1Unimedic Pharma Ab
74 5Viatris
75 2Zentiva
76 1Zydus Pharmaceuticals
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01 1CAB
02 4CAP
03 10CAPSULE
04 23CAPSULE;ORAL
05 40Capsule
06 1Capsule, hard
07 42Hard Capsule
08 1Hard Gelatin Capsule
09 2TABLET, ORALLY DISINTEGRATING;ORAL
10 9capsule
11 1Blank
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01 11Allowed
02 21Approved
03 32Authorized
04 3Cancelled
05 3DISCN
06 6Deregistered
07 1EU Approved
08 2EU Dossier Readiness-Q2 2018
09 5Generic
10 1Generic EU CTD
11 1Lead Market Dossiers- Filed
12 1Originator
13 9Prescription
14 19RX
15 19Blank
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01 1ACH-FINGOLIMOD
02 1AKM Fingolimod
03 1Danelvin
04 1FILENGIA
05 1FILOSIR
06 3FINGOLIMOD
07 18FINGOLIMOD HYDROCHLORIDE
08 1Finger Limit Normon
09 3Fingolimod Accord
10 1Fingolimod Amarox
11 2Fingolimod Aristo
12 1Fingolimod Aurorvitas
13 1Fingolimod Avansor
14 1Fingolimod Biocon
15 1Fingolimod Bluefish
16 1Fingolimod Combix
17 2Fingolimod Consumption
18 4Fingolimod Devatis
19 1Fingolimod Dr.Reddy's
20 1Fingolimod Edest
21 1Fingolimod Fresenius Kabi
22 2Fingolimod Glenmark
23 1Fingolimod Hec Pharm
24 1Fingolimod Kern Pharma
25 1Fingolimod Koanaa
26 2Fingolimod Krka
27 2Fingolimod Lupin
28 1Fingolimod Medical Valley
29 1Fingolimod Medochemie
30 2Fingolimod Mylan
31 1Fingolimod Neuraxpharm
32 1Fingolimod Orion
33 1Fingolimod Pensa
34 1Fingolimod Pharmathen
35 1Fingolimod Reddy
36 1Fingolimod SUN
37 1Fingolimod Sala
38 4Fingolimod Sandoz
39 1Fingolimod Spirig HC
40 2Fingolimod Stada
41 1Fingolimod Sun
42 2Fingolimod Swanpond Investments
43 1Fingolimod Tecnigen
44 2Fingolimod Teva
45 2Fingolimod Tillomed
46 1Fingolimod Towa
47 1Fingolimod Unimedic Pharma
48 1Fingolimod Viatris
49 2Fingolimod Zentiva
50 2Fingolimod-Mepha
51 1Fingolimod-Teva
52 1Finkem
53 1Fynod
54 4GILENYA
55 2Gaxenim
56 8Gilenya
57 1Glomatin
58 1Golpimec
59 2Inzolfi
60 1JAMP FINGOLIMOD
61 1Kinelimod
62 2Lognif
63 1MYLAN-FINGOLIMOD
64 1Myelenea
65 1PMS-FINGOLIMOD
66 1Pharmacor Fingolimod
67 1SANDOZ FINGOLIMOD
68 1TARO-FINGOLIMOD
69 2TASCENSO ODT
70 1TEVA-FINGOLIMOD
71 1Tugivin 0,5 mg
72 10Blank
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01 10Australia
02 9Canada
03 2Germany
04 1Greece
05 4India
06 1Iran
07 1Norway
08 2Portugal
09 5South Africa
10 35Spain
11 27Sweden
12 11Switzerland
13 1Turkey
14 25USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Fingolimod Orion
Dosage Form : Capsule
Dosage Strength : 0.5mg
Packaging :
Approval Date : 09/03/2021
Application Number : 20190325000084
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Fingolimod Towa
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2024-12-26
Application Number : 89913
Regulatory Info : Authorized
Registration Country : Spain
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Fingolimod Reddy
Dosage Form : Capsule
Dosage Strength : 0.5mg
Packaging :
Approval Date : 04/04/2022
Application Number : 20210401000064
Regulatory Info : Approved
Registration Country : Sweden
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
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Fingolimod Pharmathen
Dosage Form : Hard Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date : 2020-10-20
Application Number : 85499
Regulatory Info : Authorized
Registration Country : Spain
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 : 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 : 2023-12-06
Application Number : 207945
Regulatory Info : RX
Registration Country : USA
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