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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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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Approved

Registration Country : Sweden

Hydroxycarbamide

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

Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Authorized

Registration Country : Spain

Hydroxycarbamide

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

Company Banner

03

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Hydroxyurea

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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04

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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05

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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06

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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07

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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08

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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09

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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10

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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11

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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12

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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

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13

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Hydroxyurea

Brand Name :

Dosage Form : Capsule

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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14

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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15

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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16

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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17

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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18

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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19

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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20

PH HEALTH

Country
Fall Technical Meeting
Not Confirmed
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PH HEALTH

Country
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Fall Technical Meeting
Not Confirmed

HYDROXYUREA

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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