medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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01 2medac
02 12care4
03 1Accure Labs
04 1Apotex Inc
05 1Aprazer
06 5Barr Laboratories
07 3Belmedpreparaty
08 5Cheplapharm Arzneimittel Gmbh
09 1Clinigen Group
10 1Deva Holding AS
11 1Devatis AG
12 1Europharma
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15 1Health Biotech
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24 1Link Healthcare
25 2Lipomed AG
26 1MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH
27 1Medsurge Healthcare
28 1Naprod Life Sciences
29 1Nova Laboratories
30 8ORIFARM GROUP AS
31 1P & D Pharmaceuticals Limited
32 1PH HEALTH
33 2Paranova Pharmaceuticals Ab
34 2Pharmacenter
35 1Qilu Pharmaceutical
36 1ROXANE
37 1Sakar Healthcare
38 1TEOFARMA Srl
39 10Theravia
40 1Viatris
41 4Waylis Therapeutics
42 1West-Coast Pharmaceuticals
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01 1CAP
02 5CAPSULE
03 12CAPSULE;ORAL
04 32Capsule
05 2Capsules
06 8Film Coated Tablet
07 2Film-Coated Tablet
08 5Hard Capsule
09 1Idroxicarbamide 500Mg 20 Joined' Oral Use
10 2Oral Solution
11 1SOLUTION;ORAL
12 3TABLET;ORAL
13 2Blank
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01 5Allowed
02 6Approved
03 5Authorized
04 8DISCN
05 8Deregistered
06 1EU CTD Dossier Available
07 1EU CTD dossier Available
08 3Generic
09 4Marketed
10 2Not Marketed
11 1Originator
12 11Prescription
13 8RX
14 1Withdrawn
15 12Blank
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01 1APO-HYDROXYUREA
02 1APRAHYDRO
03 2Cyclos
04 3DROXIA
05 2HYDREA
06 1HYDROXYCARBAMIDE MEDSURGE
07 9HYDROXYUREA
08 1HYPI-500
09 1Hidroxicarbamida Medac
10 1Hidroxiurea Eczane
11 9Hydra
12 7Hydrea
13 1Hydrea 500mg Capsule
14 3Hydroxycarbamide
15 1Hydroxycarbamide Devatis
16 1Hydroxycarbamide Hikma
17 1Hydroxycarbamide Labatec
18 1Hydroxycarbamide Orifarm
19 1Hydroxyurea Medac
20 1Hydroxyurea Orifarm
21 2Hydroxyurea medac
22 1Litalir
23 1MYLAN-HYDROXYUREA
24 1Onco Carbide
25 1Oribamide
26 1RIVA-HYDROXYUREA
27 2SIKLOS
28 8Siklos
29 1XROMI
30 2Xromi
31 8Blank
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01 1Argentina
02 2Australia
03 4Canada
04 7Estonia
05 2Hungary
06 7India
07 1Italy
08 1Malta
09 3Moldova
10 6Norway
11 1South Africa
12 5Spain
13 14Sweden
14 5Switzerland
15 1Turkey
16 16USA
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Hydroxyurea Medac
Dosage Form : Capsule
Dosage Strength : 500mg
Packaging :
Approval Date : 09/10/1998
Application Number : 19981009000032
Regulatory Info : Approved
Registration Country : Sweden
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Hidroxicarbamida Medac
Dosage Form : Hard Capsule
Dosage Strength : 500MG
Packaging :
Approval Date : 14-12-2023
Application Number : 89193
Regulatory Info : Authorized
Registration Country : Spain
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Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : CAPSULE
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1998-07-30
Application Number : 75020
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 250MG
Packaging :
Approval Date : 2000-06-26
Application Number : 75020
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1998-10-16
Application Number : 75143
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 250MG
Packaging :
Approval Date : 2000-09-21
Application Number : 75143
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2000-08-29
Application Number : 75734
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India

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Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2020-04-08
Application Number : 213438
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : XROMI
Dosage Form : SOLUTION;ORAL
Dosage Strength : 100MG/ML
Packaging :
Approval Date : 2024-04-04
Application Number : 216593
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2024-03-06
Application Number : 218021
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1995-08-18
Application Number : 74476
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : SIKLOS
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2017-12-21
Application Number : 208843
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : SIKLOS
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2017-12-21
Application Number : 208843
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : HYDREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1982-01-01
Application Number : 16295
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : DROXIA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 1998-02-25
Application Number : 16295
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : DROXIA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Packaging :
Approval Date : 1998-02-25
Application Number : 16295
Regulatory Info : DISCN
Registration Country : USA

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Regulatory Info : DISCN
Registration Country : USA
Brand Name : DROXIA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 1998-02-25
Application Number : 16295
Regulatory Info : DISCN
Registration Country : USA

Regulatory Info : RX
Registration Country : USA
Brand Name : HYDROXYUREA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 1999-02-24
Application Number : 75340
Regulatory Info : RX
Registration Country : USA

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