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 1Accure Labs
03 1Apotex Inc
04 1Aprazer
05 5Barr Laboratories
06 4Cheplapharm Arzneimittel Gmbh
07 1Clinigen Group
08 1Deva Holding AS
09 1Devatis AG
10 1Europharma
11 1Flagship Biotech International Pvt. Ltd
12 1Health Biotech
13 1Hikma Pharmaceuticals
14 2Iqone Healthcare Switzerland Sa
15 1Labatec Pharm
16 1Laboratoire Riva
17 1Laboratorio Eczane Pharma
18 1Leading Pharma, LLC
19 1Link Healthcare
20 1Lipomed AG
21 1MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH
22 1Medsurge Healthcare
23 1Naprod Life Sciences
24 1Nova Laboratories
25 7ORIFARM GROUP AS
26 1P & D Pharmaceuticals Limited
27 1PH HEALTH
28 2Paranova Pharmaceuticals Ab
29 2Pharmacenter
30 1Qilu Pharmaceutical
31 1ROXANE
32 1Sakar Healthcare
33 1TEOFARMA Srl
34 6Theravia
35 1Viatris
36 4Waylis Therapeutics
37 1West-Coast Pharmaceuticals
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01 1CAP
02 5CAPSULE
03 12CAPSULE;ORAL
04 21Capsule
05 2Capsule, hard
06 2Capsules
07 6Film Coated Tablet
08 5Hard Capsule
09 1Idroxicarbamide 500Mg 20 Joined' Oral Use
10 1Oral 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 1Originator
10 4Prescription
11 8RX
12 1Withdrawn
13 11Blank
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01 1APO-HYDROXYUREA
02 1APRAHYDRO
03 3DROXIA
04 2HYDREA
05 1HYDROXYCARBAMIDE MEDSURGE
06 9HYDROXYUREA
07 1HYPI-500
08 1Hidroxicarbamida Medac
09 1Hidroxiurea Eczane
10 7Hydra
11 4Hydrea
12 1Hydrea 500mg Capsule
13 1Hydroxycarbamide Devatis
14 1Hydroxycarbamide Hikma
15 1Hydroxycarbamide Labatec
16 1Hydroxycarbamide Orifarm
17 2Hydroxyurea Medac
18 1Hydroxyurea Orifarm
19 1Litalir
20 1MYLAN-HYDROXYUREA
21 1Onco Carbide
22 1Oribamide
23 1RIVA-HYDROXYUREA
24 2SIKLOS
25 6Siklos
26 1XROMI
27 1Xromi
28 8Blank
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01 1Argentina
02 2Australia
03 4Canada
04 2Hungary
05 7India
06 1Italy
07 1Malta
08 2Norway
09 1South Africa
10 5Spain
11 14Sweden
12 5Switzerland
13 1Turkey
14 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 : 2023-12-14
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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