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 8Cheplapharm 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 1PH HEALTH
26 2Paranova Pharmaceuticals Ab
27 2Pharmacenter
28 1Qilu Pharmaceutical
29 1ROXANE
30 1Sakar Healthcare
31 1TEOFARMA Srl
32 6Theravia
33 1Viatris
34 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 4Hard 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 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 3Hydrea
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 2Norway
08 1South Africa
09 5Spain
10 14Sweden
11 5Switzerland
12 1Turkey
13 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
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
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
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
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
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
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
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
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
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
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 : Generic
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
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
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
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
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
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
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
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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