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