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    Cheplapharm Arzneimittel Gmbh'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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    Cheplapharm Arzneimittel Gmbh

    EVENTS

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    DIGITAL CONTENT

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    01 4ALFACALCIDOL

    02 1AMPHOTERICIN B

    03 2BUDESONIDE

    04 3BUSERELIN (BUSERELIN ACETATE)

    05 7CANDESARTAN CILEXETIL

    06 2CAPECITABINE

    07 2CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

    08 7CLONAZEPAM

    09 1Calcium carbonate; Cholecalciferol

    10 6Candesartan cilexetil

    11 4Candesartan cilexetil; Hydrochlorothiazide

    12 2Capecitabine

    13 2Carvedilol

    14 2Clomethiazole

    15 1DEXAMETHASONE (DEXAMETHASONE SODIUM METASULPHOBENZOATE)

    16 1DISOPYRAMIDE

    17 1ETOPOSIDE

    18 1ETOPOSIDE PHOSPHATE

    19 1FRAMYCETIN SULFATE

    20 2Flumazenil

    21 1GANCICLOVIR (GANCICLOVIR SODIUM)

    22 1GANCICLOVIR SODIUM

    23 1GRAMICIDIN

    24 4HYDROCHLOROTHIAZIDE

    25 5HYDROXYUREA

    26 1Manidipine

    27 1NILUTAMIDE

    28 11OLANZAPINE

    29 3OLANZAPINE PAMOATE

    30 1OMEPRAZOLE

    31 1OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)

    32 2ORLISTAT

    33 14Olanzapine

    34 3Olanzapine embonate monohydrate

    35 6Omeprazole

    36 1Orlistat

    37 3Pioglitazone

    38 1Pioglitazone; Metformin

    39 10Quetiapine

    40 1Sotalol

    41 3Spironolactone

    42 2TRETINOIN

    43 1Ticlopidine

    44 1Tretinoin

    45 4Ursodeoxycholic Acid

    46 4Ursodeoxycholic acid

    47 2VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

    48 2VALGANCICLOVIR HYDROCHLORIDE

    49 1VERTEPORFIN

    50 1Valganciclovir

    51 1clomethiazole

    52 1klometiazoledisilat

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    Regulatory Info : Prescription

    Registration Country : Canada

    ALFACALCIDOL

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : CAPSULE

    Brand Name : ONE-ALPHA

    Dosage Strength : 0.25MCG

    Packaging :

    Approval Date :

    Application Number : 474517

    Regulatory Info : Prescription

    Registration Country : Canada

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    02

    Brand Name : ONE-ALPHA

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    Regulatory Info : Prescription

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    ALFACALCIDOL

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : CAPSULE

    Brand Name : ONE-ALPHA

    Dosage Strength : 1MCG

    Packaging :

    Approval Date :

    Application Number : 474525

    Regulatory Info : Prescription

    Registration Country : Canada

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    03

    Brand Name : ONE-ALPHA

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    Regulatory Info : Prescription

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    ALFACALCIDOL

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : DROPS

    Brand Name : ONE-ALPHA

    Dosage Strength : 2MCG/ML

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    Approval Date :

    Application Number : 2240329

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    ALFACALCIDOL

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : SOLUTION

    Brand Name : ONE-ALPHA

    Dosage Strength : 2MCG/ML

    Packaging :

    Approval Date :

    Application Number : 2242502

    Regulatory Info : Prescription

    Registration Country : Canada

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    05

    Brand Name : FUNGIZONE

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    AMPHOTERICIN B

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : POWDER FOR SOLUTION

    Brand Name : FUNGIZONE

    Dosage Strength : 50MG/VIAL

    Packaging :

    Approval Date :

    Application Number : 29149

    Regulatory Info : Prescription

    Registration Country : Canada

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    06

    Brand Name : PULMICORT FLEXHALER

    Germany
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    Regulatory Info : RX

    Registration Country : USA

    BUDESONIDE

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : POWDER, METERED;INHALATI...

    Brand Name : PULMICORT FLEXHALER

    Dosage Strength : 0.08MG/INH

    Packaging :

    Approval Date : 2006-07-12

    Application Number : 21949

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : PULMICORT FLEXHALER

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    Dosage Form : POWDER, METERED;INHALATI...

    Brand Name : PULMICORT FLEXHALER

    Dosage Strength : 0.16MG/INH

    Packaging :

    Approval Date : 2006-07-12

    Application Number : 21949

    Regulatory Info : RX

    Registration Country : USA

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    08

    Brand Name : SUPREFACT

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    Regulatory Info : Prescription

    Registration Country : Canada

    BUSERELIN (BUSERELIN ACETATE)

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : SOLUTION

    Brand Name : SUPREFACT

    Dosage Strength : 1MG/ML

    Packaging :

    Approval Date :

    Application Number : 2225166

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    Registration Country : Canada

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    09

    Brand Name : SUPREFACT DEPOT 3 MO...

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    BUSERELIN (BUSERELIN ACETATE)

    Cheplapharm Arzneimittel Gmbh

    Dosage Form : IMPLANT

    Brand Name : SUPREFACT DEPOT 3 MONTHS

    Dosage Strength : 9.45MG

    Packaging : 3 IMPLANTS

    Approval Date :

    Application Number : 2240749

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    Registration Country : Canada

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    Brand Name : SUPREFACT DEPOT 2 MO...

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    BUSERELIN (BUSERELIN ACETATE)

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    Dosage Form : IMPLANT

    Brand Name : SUPREFACT DEPOT 2 MONTHS

    Dosage Strength : 6.3MG

    Packaging : 2 IMPLANTS

    Approval Date :

    Application Number : 2228955

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    Registration Country : Canada

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