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    Approved Marketing Authorisations (MA) of Rottapharm Biotech in Europe aggregated by PharmaCompass

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Rottapharm Biotech

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    01 1Estradiol

    02 3Terazosin

    03 1Tranexamic acid

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    01

    Brand Name : DERMESTRIL

    Italy
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    Brand Name : DERMESTRIL

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Estradiol

    Rottapharm Biotech

    Dosage Form : Transdermal Patches

    Dosage Strength : 25 micrograms/24 hours

    Packaging : 8 UNITS 25 MCG/DIE...

    Brand Name : DERMESTRIL

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Brand Name : UGUROL

    Italy
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    Brand Name : UGUROL

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Tranexamic acid

    Rottapharm Biotech

    Dosage Form : Solution For Injection For

    Dosage Strength : 500 mg/5 ml

    Packaging : 6 UNITS 500 MG - P...

    Brand Name : UGUROL

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    Brand Name : TERAFLUX

    Italy
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    Brand Name : TERAFLUX

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Terazosin

    Rottapharm Biotech

    Dosage Form : Tablets

    Dosage Strength : 5 mg

    Packaging : 14 UNIT 5 MG - ORA...

    Brand Name : TERAFLUX

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    04

    Brand Name : TERAFLUX

    Italy
    Luxepack
    Not Confirmed
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    Brand Name : TERAFLUX

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Terazosin

    Rottapharm Biotech

    Dosage Form : Tablets

    Dosage Strength : 2 mg

    Packaging : 30 UNITS 2 MG - OR...

    Brand Name : TERAFLUX

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    05

    Brand Name : TERAFLUX

    Italy
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    Not Confirmed
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    Brand Name : TERAFLUX

    Italy
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    Luxepack
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    Regulatory Info :

    Registration Country : Italy

    Terazosin

    Rottapharm Biotech

    Dosage Form : Divisible Tablet

    Dosage Strength : 5mg

    Packaging : 28 UNITS 5 MG - OR...

    Brand Name : TERAFLUX

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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