Scribd Logo
Upload

Welcome to Scribd!

  • HUAHAI Product List Commericial Short

    Uploaded by

    Nouvitch Nouvitche
    49 views1 page
    This document provides information on various APIs (active pharmaceutical ingredients) manufactured by Huahai Pharmaceuticals including the API name, therapeutic use, US and EU DMF completion dates, and CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) readiness status. Over 50 APIs are listed covering a wide range of therapeutic areas including hypertension, antipsychotics, antidepressants, diabetes, antivirals, and more. For each API, the document displays the US and EU Drug Master File numbers if available as well as the CEP reference number and revision if the CEP has been issued.

    Original Description:

    product

    Copyright

    © © All Rights Reserved

    Available Formats

    XLS, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document provides information on various APIs (active pharmaceutical ingredients) manufactured by Huahai Pharmaceuticals including the API name, therapeutic use, US and EU DMF completion dates, and CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) readiness status. Over 50 APIs are listed covering a wide range of therapeutic areas including hypertension, antipsychotics, antidepressants, diabetes, antivirals, and more. For each API, the document displays the US and EU Drug Master File numbers if available as well as the CEP reference number and revision if the CEP has been issued.

    Copyright:

    © All Rights Reserved
    Download as XLS, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xls, pdf, or txt
    49 views1 page

    HUAHAI Product List Commericial Short

    Uploaded by

    Nouvitch Nouvitche
    This document provides information on various APIs (active pharmaceutical ingredients) manufactured by Huahai Pharmaceuticals including the API name, therapeutic use, US and EU DMF completion dates, and CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) readiness status. Over 50 APIs are listed covering a wide range of therapeutic areas including hypertension, antipsychotics, antidepressants, diabetes, antivirals, and more. For each API, the document displays the US and EU Drug Master File numbers if available as well as the CEP reference number and revision if the CEP has been issued.

    Copyright:

    © All Rights Reserved
    Download as XLS, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as xls, pdf, or txt
    of 1

    HUAHAI PRODUCTS _ COMMERCIAL

    COS grant date


    Usage US DMF EU DMF
    API completion completion

    Ready

    Ambrisentan Hypertension 27505 √


    Aripiprazole Antipsychotic 25685 √ R0-CEP 2014-011-Rev 00
    Benazepril HCl ACE Inhibitor 17792 √ R0-CEP 2010-276-Rev 00
    Candesartan Cilexetil Angiotensin II Receptor Antagonist 25455 √ R0-CEP 2011-309-Rev 01
    Captopril ACE Inhibitor 14311 √ R1-CEP 1997-023-Rev 07
    Carvedilol Antihypertensive 19533 √ R1-CEP 2004-287-Rev 02
    CARVEDILOL DIHYDROGEN PHOSPHATE HEMIHYDRATE 25721
    Citalopram Hydrobromide Anti-depressant 20586 √ R0-CEP 2010-037-Rev 01
    Donepezil HCl Alzheimer's disease 23178 √
    Duloxetine hydrochloride Anti-depressant 23051 √ R0-CEP 2012-220-Rev 01
    Enalapril Maleate ACE Inhibitor 14355 √ R1-CEP 2000-053-Rev 03
    Entecavir Antiviral 27848
    Eprosartan mesylate Angiotensin II Receptor Antagonist 26230 √
    Escitalopram Oxalate Anti-depressant 20081 √
    Febuxostat HCl Chronic Gout drug 26848 √
    Fosinopril sodium ACE Inhibitor 17805 √ R0-CEP 2011-271-Rev 00
    Irbesartan Angiotensin II Receptor Antagonist 21780 √ R0-CEP 2010-033-Rev 01
    Ketotifen hydrogen fumarate Antihistaminic √ R1-CEP 2004-269-Rev 00
    Lamotrigine Anticonvulsant 23262 √ R0-CEP 2010-208-Rev 01
    Levetiracetam Antiepileptic 22235 √ R0-CEP 2012-325-Rev 00
    Lisinopril ACE Inhibitor 14801 √ R1-CEP 2003-064-Rev 03
    Losartan potassium (Process I) Angiotensin II Receptor Antagonist 22073 √ R0-CEP 2009-296-Rev 00
    Losartan potassium (ProcessII) Angiotensin II Receptor Antagonist 27198 √ R0-CEP 2010-139-Rev 01
    Nevirapine Anhydrous Anti-AIDS 19712 √ R0-CEP 2011-223-Rev 00
    Olmesartan medoxomil Angiotensin II Receptor Antagonist 26143 √ R0-CEP 2011-382-Rev 00
    Paroxetine HCl, anhydrous Anti-depressant √ R1-CEP 2006-002-Rev 01
    Paroxetine HCl, Hemihydrate Anti-depressant 19922 √ R1-CEP 2006-192-Rev 00
    Perindopril tert-butylamine ACE Inhibitor √ R1-CEP 2007-026-Rev 00
    Pioglitazone Hydrochloride Anti-diabetes 27504 √ R0-CEP 2013-143-Rev 00
    Pregabalin Convulsant 27955 √
    Quinapril Hydrochloride ACE Inhibitor 20315 √ R0-CEP 2013-102-Rev 00
    Ramipril ACE Inhibitor 24650 √ R1-CEP 2003-026-Rev 01
    Risperidone Antipsychotic 20518 √ R1-CEP 2006-308-Rev 00
    Rocuronium Bromide Muscle Relaxants √
    Ropinirole Hydrochloride Antiparkinsonian 20829 √
    Strontium ranelate Bone Calcium Regulator √
    Sitagliptin Diabetes √
    Tadalafil Erectile dysfunction 27479 √ R0-CEP 2013-189-Rev 00
    Telmisartan Angiotensin II Receptor Antagonist 21466 √ R1-CEP 2009-077-Rev 00
    Torasemide Diuretic 24549 √ R1-CEP 2009-061-Rev 03
    Tolvaptan Congestive heart failure 27132 √
    Valsartan Angiotensin II Receptor Antagonist 23491 √ R0-CEP2010-072-Rev 01
    Voriconazole Antifungal 25707 √ R0-CEP2011-365-Rev 00

    page 1 of 1,
    June 8,2013

    You might also like