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    Clinigen Group's list of EU CTD Dossiers, Marketing Authorizations, In, Out Licensing Opportunities & Finished Dosage Formulations 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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    Clinigen Group

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    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    01 1300 mg zidovudine

    02 2AMIFOSTINE

    03 1AMINOSALICYLIC ACID

    04 1Abacavir Sulphate

    05 1Abacavir sulphate

    06 2Abatacept

    07 1Acetylcysteine

    08 1Alendronic acid

    09 3Alprazolam

    10 1Amifostine

    11 2Amlodipine besilate

    12 1Amphotericin B

    13 1Anhydrous Cholestyramine

    14 1Artesunate

    15 2Atazanavir

    16 2Azithromycin Dihydrate

    17 1Betahistine dihydrochloride

    18 2Budesonide

    19 2CARGLUMIC ACID

    20 2Caffeine Citrate

    21 2Capecitabine

    22 3Carbidopa

    23 3Cefepime

    24 2Celecoxib

    25 1Citalopram

    26 1Clindamycin

    27 1DEXRAZOXANE HYDROCHLORIDE

    28 1Daptomycin

    29 4Dasatinib

    30 1Decitabine

    31 2Dexrazoxane

    32 1Dexrazoxane HCl

    33 4Didanosine

    34 2Dolutegravir

    35 5Efavirenz

    36 2Emtricitabine

    37 3Entacapone

    38 2Entecavir

    39 1Eribulin Mesilate

    40 1Esmolol hydrochloride

    41 1Exemestane

    42 1FOSCARNET SODIUM

    43 1Foscarnet

    44 1Hemin

    45 4Hydrochlorothiazide

    46 1Hydroxyurea

    47 1IBUPROFEN

    48 2Ipilimumab

    49 1Iron Sucrose

    50 5Lamivudine

    51 2Lenvatinib

    52 1Letrozole

    53 3Levodopa

    54 5Lisinopril

    55 1Mercaptopurine

    56 4Mesalazine

    57 3Metformin hydrochloride

    58 1Methadone

    59 1Methadone Hydrochloride

    60 1Methoxyflurane

    61 2Mirtazapine

    62 1Natamycin

    63 2Nevirapine

    64 1Nitrofurantoin 50mg

    65 2Omeprazole

    66 3Paclitaxel

    67 3Paracetamol

    68 6Perampanel

    69 1Perindopril tert-butylamine

    70 2Quinapril hydrochloride

    71 1Rifaximin

    72 4Simvastatin

    73 1Tenofovir

    74 2Tenofovir Disoproxil Fumarate

    75 1Tenofovir Disporoxil Fumarate

    76 1Tenofovir disoproxil fumarate

    77 1Tranexamic Acid

    78 3Zidovudine

    79 1Zolpidem tartrate

    80 2telavancin hydrochloride

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    01

    Brand Name : Lodiz

    South Africa
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    Brand Name : Lodiz

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    300 mg zidovudine

    Novagen Pharma

    Dosage Form : FCT

    Brand Name : Lodiz

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Brand Name : Invertron Tablets 30...

    South Africa
    Discovery on Target
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    Brand Name : Invertron Tablets 30...

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir sulphate

    Novagen Pharma

    Dosage Form : FCT

    Brand Name : Invertron Tablets 300 mg

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    03

    Brand Name : Invertron Oral Solut...

    South Africa
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    Brand Name : Invertron Oral Solut...

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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir Sulphate

    Novagen Pharma

    Dosage Form : SOL

    Brand Name : Invertron Oral Solution 2...

    Dosage Strength : 20mg/ml

    Packaging : 240X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Brand Name : Orencia 250mg

    United Kingdom
    Discovery on Target
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    Brand Name : Orencia 250mg

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abatacept

    Clinigen Group

    Dosage Form : INF

    Brand Name : Orencia 250mg

    Dosage Strength : 250mg/10ml

    Packaging : 10X1mg/10ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    05

    Brand Name : ORENCIA 125 mg

    United Kingdom
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    Brand Name : ORENCIA 125 mg

    United Kingdom
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abatacept

    Clinigen Group

    Dosage Form : PFS

    Brand Name : ORENCIA 125 mg

    Dosage Strength : 125mg/1ml

    Packaging : 1X4mg/1ml

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Market
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    06

    Brand Name : Paradote

    United Kingdom
    Discovery on Target
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    Brand Name : Paradote

    United Kingdom
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    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Acetylcysteine

    Clinigen Group

    Dosage Form : INJ

    Brand Name : Paradote

    Dosage Strength : 200mg/ml

    Packaging : 10X10mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    07

    Brand Name : Densate 70 mg

    South Africa
    Discovery on Target
    Not Confirmed
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    Brand Name : Densate 70 mg

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alendronic acid

    Novagen Pharma

    Dosage Form : TAB

    Brand Name : Densate 70 mg

    Dosage Strength : 70mg

    Packaging : 4X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    08

    Brand Name : Novapraz XR 0.5

    South Africa
    Discovery on Target
    Not Confirmed
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    Brand Name : Novapraz XR 0.5

    South Africa
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    Discovery on Target
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alprazolam

    Novagen Pharma

    Dosage Form : SRT

    Brand Name : Novapraz XR 0.5

    Dosage Strength : 0.5mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    09

    Brand Name : Novapraz XR 1

    South Africa
    Discovery on Target
    Not Confirmed
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    Brand Name : Novapraz XR 1

    South Africa
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    Discovery on Target
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alprazolam

    Novagen Pharma

    Dosage Form : SRT

    Brand Name : Novapraz XR 1

    Dosage Strength : 1mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    10

    Brand Name : Novapraz XR 2

    South Africa
    Discovery on Target
    Not Confirmed
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    Brand Name : Novapraz XR 2

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alprazolam

    Novagen Pharma

    Dosage Form : SRT

    Brand Name : Novapraz XR 2

    Dosage Strength : 2mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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