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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    Hydroxyurea

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    IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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    Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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    Hydroxyurea

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    medac

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

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    Regulatory Info : Approved

    Registration Country : Sweden

    Hydroxycarbamide

    Brand Name : Hydroxyurea Medac

    Dosage Form : Capsule

    Dosage Strength : 500mg

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    Approval Date : 09/10/1998

    Application Number : 19981009000032

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    medac

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

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    Regulatory Info : Authorized

    Registration Country : Spain

    Hydroxycarbamide

    Brand Name : Hidroxicarbamida Medac

    Dosage Form : Hard Capsule

    Dosage Strength : 500MG

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    Approval Date : 14-12-2023

    Application Number : 89193

    Regulatory Info : Authorized

    Registration Country : Spain

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    03

    medac

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

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Hydroxycarbamide

    Brand Name : Hydroxyurea \"Medac\"

    Dosage Form : Hard Capsules

    Dosage Strength : 500mg

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    Approval Date : 19-03-2001

    Application Number : 28103179700

    Regulatory Info : Prescription

    Registration Country : Denmark

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    04

    Accure Labs

    India
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    Regulatory Info : Generic

    Registration Country : India

    Hydroxyurea

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    Dosage Form : CAPSULE

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    Regulatory Info : Generic

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    05

    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1998-07-30

    Application Number : 75020

    Regulatory Info : DISCN

    Registration Country : USA

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    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

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    Approval Date : 2000-06-26

    Application Number : 75020

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Barr Laboratories

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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 1998-10-16

    Application Number : 75143

    Regulatory Info : RX

    Registration Country : USA

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    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 250MG

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    Approval Date : 2000-09-21

    Application Number : 75143

    Regulatory Info : DISCN

    Registration Country : USA

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    Barr Laboratories

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    Regulatory Info : DISCN

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : TABLET;ORAL

    Dosage Strength : 1GM

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    Approval Date : 2000-08-29

    Application Number : 75734

    Regulatory Info : DISCN

    Registration Country : USA

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    Leading Pharma, LLC

    U.S.A
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 2020-04-08

    Application Number : 213438

    Regulatory Info : RX

    Registration Country : USA

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    11

    Nova Laboratories

    United Kingdom
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : XROMI

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : 100MG/ML

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    Approval Date : 2024-04-04

    Application Number : 216593

    Regulatory Info : RX

    Registration Country : USA

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    12

    Qilu Pharmaceutical

    China
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : HYDROXYUREA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 500MG

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    Approval Date : 2024-03-06

    Application Number : 218021

    Regulatory Info : RX

    Registration Country : USA

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    13

    ROXANE

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    Regulatory Info : DISCN

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    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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    14

    Theravia

    France
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    Regulatory Info : RX

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    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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    Theravia

    France
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    Regulatory Info : RX

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    HYDROXYUREA

    Brand Name : SIKLOS

    Dosage Form : TABLET;ORAL

    Dosage Strength : 1GM

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    Approval Date : 2017-12-21

    Application Number : 208843

    Regulatory Info : RX

    Registration Country : USA

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    16

    Waylis Therapeutics

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    Regulatory Info : RX

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    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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    Waylis Therapeutics

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    Regulatory Info : DISCN

    Registration Country : USA

    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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    18

    Waylis Therapeutics

    U.S.A
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    Regulatory Info : DISCN

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    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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    19

    Waylis Therapeutics

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    HYDROXYUREA

    Brand Name : DROXIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 400MG

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    Approval Date : 1998-02-25

    Application Number : 16295

    Regulatory Info : DISCN

    Registration Country : USA

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    PH HEALTH

    Country
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    Regulatory Info : RX

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    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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