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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alembic Pharmaceuticals Limited

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6-AMINOPENICILLANIC ACID

AFATINIB DIMALEATE

ALENDRONATE SODIUM USP

ALOGLIPTIN BENZOATE

APIXABAN

APREMILAST

ARIPIPRAZOLE USP

ASENAPINE MALEATE

AZILSARTAN MEDOXOMIL MONOPOTASSIUM

AZITHROMYCIN DIHYDRATE USP

AZITHROMYCIN MONOHYDRATE

AZITHROMYCIN MONOHYDRATE USP

AZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

Axitinib OH)

Azilsartan Medoxomil Monopotassium (IH)

BOSENTAN

BOSUTINIB

BUPROPION HYDROCHLORIDE USP

Bupropion Hydrochloride

CANAGLIFLOZIN

CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL USP (CND PROCESS)

CELECOXIB USP

CILOSTAZOL

CLARITHROMYCIN

CLARITHROMYCIN USP

CLONIDINE HYDROCHLORIDE USP

CLONIDINE USP

CLOPIDOGREL BISULFATE USP

Cefepime hydrochloride hydrate

Celecoxib Ph.Eur

DABIGATRAN ETEXILATE MESYLATE

DAPAGLIFLOZIN

DARIFENACIN HYDROBROMIDE

DASATINIB

DEFERASIROX

DONEPEZIL HYDROCHLORIDE MONOHYDRATE USP

DRONEDARONE HYDROCHLORIDE USP

DULOXETINE HYDROCHLORIDE USP

DULOXETINE HYDROCHLORIDE USP (DUX PROCES)

Deferasirox

EMPAGLIFLOZIN

ERLOTINIB HYDROCHLORIDE

ERYTHROMYCIN ETHYLSUCCINATE USP

ERYTHROMYCIN USP

ETORICOXIB

Erythromycin Estolate

Etoricoxib

FAMOTIDINE USP

FEBUXOSTAT

FELODIPINE USP

FENOFIBRATE USP

FENOFIBRIC ACID

FENOFIBRIC ACID CHOLINE SALT

FESOTERODINE FUMARATE

FINGOLIMOD HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE USP

Fenofibrate Process-II

Fenofibric Acid Cholin Salt (IH)

GEFITINIB

HYDROCHLOROTHIAZIDE USP

ILOPERIDONE

IRBESARTAN USP

IVABRADINE HYDROCHLORIDE

IVACAFTOR

Irbesartan

LACOSAMIDE

LAMOTRIGINE USP

LEFLUNOMIDE USP

LINAGLIPTIN

LINEZOLID

LOSARTAN POTASSIUM USP

LOVASTATIN USP

LURASIDONE HYDROCHLORIDE

Lercanidipine Hydrochloride (IH)

Levetiracetam

MACITENTAN

MEMANTINE HYDROCHLORIDE USP

MEPROBAMATE USP

METOPROLOL SUCCINATE USP

METOPROLOL TARTRATE USP

MEXILETINE HYDROCHLORIDE USP

MODAFINIL USP

Minodronic Acid Hydrates IH

Moclobemide

Modafinil

NISOLDIPINE

Nitazoxanide

O-DESMETHYL VENLAFAXINE

O-DESMETHYL VENLAFAXINE SUCCINATE MONOHYDRATE

O-Desmethyl Venlafaxine Succinate Monohydrate (IH)

OLAPARIB

OLMESARTAN MEDOXOMIL USP

Olmesartan Medoximil Ph.Eur

PENTOSAN POLYSULFATE SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP

PRASUGREL HYDROCHLORIDE

PREGABALIN USP

Pramipexole Dihydrochloride Monohydrate (EP)

Prasugrel (IH)

Pregabalin (EP)

QUETIAPINE FUMARATE USP

RABEPRAZOLE SODIUM

RIOCIGUAT

RIVAROXABAN

RIVASTIGMINE TARTRATE USP

RIVASTIGMINE USP

ROPINIROLE HYDROCHLORIDE USP

Rivastigmine hydrogen tartrate

Ropinirole Hydrochloride (USP)

Rosuvastatin Calcium

Roxithromycin

SILODOSIN

SOFOSBUVIR

SOLIFENACIN SUCCINATE

SORAFENIB TOSYLATE

Sodium alendronate trihydrate

TADALAFIL USP

TELMISARTAN USP

TERIFLUNOMIDE

TICAGRELOR

TOPIRAMATE

TOPIRAMATE USP

VALSARTAN USP (PROCESS II)

VALSARTAN USP (PROCESS III)

VARDENAFIL HYDROCHLORIDE USP

VENLAFAXINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE USP

VILAZODONE HYDROCHLORIDE

VORTIOXETINE HYDROBROMIDE

Valsartan USP ( PROCESS I)

Vildagliptin (IH)

WARFARIN SODIUM AMORPHOUS USP

WARFARIN SODIUM CLATHRATE USP

ZOLMITRIPTAN USP

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Status - Active

Status - Inactive

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VALID

WITHDRAWN BY HOLDER

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218MF10414

219MF10134

219MF10311

221MF10008

227MF10284

228MF10151

228MF10173

229MF10012

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WC-0081

WC-0082

WC-0083

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AFATINIB DIMALEATE
Issue/Submission Date
2017-06-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
AFATINIB DIMALEATE
Issue/Submission Date
2017-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
ALENDRONATE SODIUM USP
Issue/Submission Date
2007-06-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
ALENDRONATE SODIUM USP
Issue/Submission Date
2007-06-25
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ALOGLIPTIN BENZOATE
Issue/Submission Date
2015-12-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ALOGLIPTIN BENZOATE
Issue/Submission Date
2015-12-30
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
6-AMINOPENICILLANIC ACID
Issue/Submission Date
2009-02-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
6-AMINOPENICILLANIC ACID
Issue/Submission Date
2009-02-02
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APIXABAN
Issue/Submission Date
2015-09-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Apixaban (IH)
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
APIXABAN
Apixaban (IH)
Issue/Submission Date
2015-09-30
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST
Issue/Submission Date
2017-10-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
APREMILAST
Issue/Submission Date
2017-10-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2009-11-18
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Aripiprazole
Issue/Submission Date
2019-01-22
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
ARIPIPRAZOLE USP
Aripiprazole
Issue/Submission Date
2009-11-18
2019-01-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ASENAPINE MALEATE
Issue/Submission Date
2013-07-04
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Asenapine Maleate (IH)
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
ASENAPINE MALEATE
Asenapine Maleate (IH)
Issue/Submission Date
2013-07-04
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Axitinib OH)
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
 
Valid - 2019-07-02
Filing Details
Axitinib OH)
Issue/Submission Date
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AZILSARTAN MEDOXOMIL MONOPOTASSIUM
Issue/Submission Date
2015-06-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
AZILSARTAN MEDOXOMIL MONOPOTASSIUM
Issue/Submission Date
2015-06-30
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Azilsartan Medoxomil Monopotassium ...
Issue/Submission Date
2017-02-14
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
 
Valid - 2019-07-02
Filing Details
Azilsartan Medoxomil Monopotassium ...
Issue/Submission Date
2017-02-14
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZITHROMYCIN MONOHYDRATE
Issue/Submission Date
2003-12-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Azithromycin Monohydrate
Issue/Submission Date
2018-05-03
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Azithromycin Monohydrate (EP)
Issue/Submission Date
2017-03-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
AZITHROMYCIN MONOHYDRATE
Azithromycin Monohydrate
Azithromycin Monohydrate (EP)
Issue/Submission Date
2003-12-31
2018-05-03
2017-03-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AZITHROMYCIN MONOHYDRATE USP (PROCE...
Issue/Submission Date
2011-02-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
AZITHROMYCIN MONOHYDRATE USP (PROCE...
Issue/Submission Date
2011-02-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AZITHROMYCIN DIHYDRATE USP
Issue/Submission Date
2007-07-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Azithromycin Dihydrate
Issue/Submission Date
2018-03-09
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Azithromycin hydrate at Alembic Roa...
Issue/Submission Date
2007-10-05
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Azithromycin Dihydrate (EP)
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
AZITHROMYCIN DIHYDRATE USP
Azithromycin Dihydrate
Azithromycin hydrate at Alembic Roa...
Azithromycin Dihydrate (EP)
Issue/Submission Date
2007-07-30
2018-03-09
2007-10-05
2016-08-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
AZITHROMYCIN MONOHYDRATE USP
Issue/Submission Date
2005-08-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
AZITHROMYCIN MONOHYDRATE USP
Issue/Submission Date
2005-08-31
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BOSENTAN
Issue/Submission Date
2011-06-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Bosentan
Issue/Submission Date
2016-08-23
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
BOSENTAN
Bosentan
Issue/Submission Date
2011-06-30
2016-08-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BOSUTINIB
Issue/Submission Date
2016-06-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
BOSUTINIB
Issue/Submission Date
2016-06-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
BUPROPION HYDROCHLORIDE USP
Issue/Submission Date
2008-09-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Bupropion Hydrochloride (USP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
BUPROPION HYDROCHLORIDE USP
Bupropion Hydrochloride (USP)
Issue/Submission Date
2008-09-26
2016-10-26
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0083
Status
Valid - 2019-07-02
Filing Details
Bupropion Hydrochloride
Issue/Submission Date
2016-06-08
Supporting Info
Application Number
Indian CDSCO WC-0083
Status
 
Valid - 2019-07-02
Filing Details
Bupropion Hydrochloride
Issue/Submission Date
2016-06-08
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-12-02
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-12-02
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CANDESARTAN CILEXETIL
Issue/Submission Date
2008-03-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Candesartan cilexetil
Issue/Submission Date
2018-09-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0083
Status
Valid - 2019-07-02
Filing Details
Candesartan Cilexetil
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0083
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CANDESARTAN CILEXETIL
Candesartan cilexetil
Candesartan Cilexetil
Issue/Submission Date
2008-03-31
2018-09-06
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CANDESARTAN CILEXETIL USP (CND PROC...
Issue/Submission Date
2016-02-19
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CANDESARTAN CILEXETIL USP (CND PROC...
Issue/Submission Date
2016-02-19
Supporting Info
See all info for this product

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Cefepime hydrochloride hydrate at A...
Issue/Submission Date
2007-04-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Cefepime hydrochloride hydrate at A...
Issue/Submission Date
2007-04-18
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
CELECOXIB USP
Issue/Submission Date
2010-11-30
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Celecoxib
Issue/Submission Date
2018-09-13
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Celecoxib (EP)
Issue/Submission Date
2017-03-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CELECOXIB USP
Celecoxib
Celecoxib (EP)
Issue/Submission Date
2010-11-30
2018-09-13
2017-03-22
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0083
Status
Valid - 2019-07-02
Filing Details
Celecoxib Ph.Eur
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0083
Status
 
Valid - 2019-07-02
Filing Details
Celecoxib Ph.Eur
Issue/Submission Date
2016-07-19
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CILOSTAZOL
Issue/Submission Date
2004-06-22
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CILOSTAZOL
Issue/Submission Date
2004-06-22
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLARITHROMYCIN
Issue/Submission Date
2003-08-07
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clarithromycin
Issue/Submission Date
2019-01-28
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Clarithromycin at Alembic Road, Vad...
Issue/Submission Date
2009-01-13
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Ciarithromycin (EP)
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
VALID
 
Valid - 2019-07-02
Filing Details
CLARITHROMYCIN
Clarithromycin
Clarithromycin at Alembic Road, Vad...
Ciarithromycin (EP)
Issue/Submission Date
2003-08-07
2019-01-28
2009-01-13
2016-08-22
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Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLARITHROMYCIN USP
Issue/Submission Date
2006-11-21
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clarithromycin Process II
Issue/Submission Date
2018-07-26
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Filing Details
CLARITHROMYCIN USP
Clarithromycin Process II
Issue/Submission Date
2006-11-21
2018-07-26
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USDMF

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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
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CLONIDINE USP
Issue/Submission Date
2014-09-30
Supporting Info
CEP/COS

Application Number
Status
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Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
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CLONIDINE USP
Issue/Submission Date
2014-09-30
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Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CLONIDINE HYDROCHLORIDE USP
Issue/Submission Date
2008-12-24
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Clonidine hydrochloride
Issue/Submission Date
2018-08-23
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Clonidine Hydrochloride (USP)
Issue/Submission Date
2016-10-26
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
CLONIDINE HYDROCHLORIDE USP
Clonidine hydrochloride
Clonidine Hydrochloride (USP)
Issue/Submission Date
2008-12-24
2018-08-23
2016-10-26
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
CLOPIDOGREL BISULFATE USP
Issue/Submission Date
2011-04-12
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
CLOPIDOGREL BISULFATE USP
Issue/Submission Date
2011-04-12
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DABIGATRAN ETEXILATE MESYLATE
Issue/Submission Date
2013-12-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Dabigatran Etexilate Mesylate
Issue/Submission Date
2016-08-23
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
DABIGATRAN ETEXILATE MESYLATE
Dabigatran Etexilate Mesylate
Issue/Submission Date
2013-12-31
2016-08-23
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DAPAGLIFLOZIN
Issue/Submission Date
2017-08-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DAPAGLIFLOZIN
Issue/Submission Date
2017-08-31
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DARIFENACIN HYDROBROMIDE
Issue/Submission Date
2012-06-27
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Darifenacin Hydrobrbmide
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
DARIFENACIN HYDROBROMIDE
Darifenacin Hydrobrbmide
Issue/Submission Date
2012-06-27
2016-09-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DASATINIB
Issue/Submission Date
2017-03-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DASATINIB
Issue/Submission Date
2017-03-31
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEFERASIROX
Issue/Submission Date
2013-02-27
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Deferasirox (1H)
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
DEFERASIROX
Deferasirox (1H)
Issue/Submission Date
2013-02-27
2016-08-22
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
Issue/Submission Date
2009-12-31
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Donepezil Hydrochloride
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
DONEPEZIL HYDROCHLORIDE MONOHYDRATE...
Donepezil Hydrochloride
Issue/Submission Date
2009-12-31
2016-09-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Issue/Submission Date
2013-03-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Dronedarone Hydrochloride
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-07-02
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone Hydrochloride
Issue/Submission Date
2013-03-26
2016-09-06
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DULOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2010-04-09
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Duloxetine hydrochloride
Issue/Submission Date
2018-11-29
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0082
Status
Valid - 2019-07-02
Filing Details
Duloxetine Hydrochloride (Ph. Eur.)
Issue/Submission Date
2016-08-23
Supporting Info
Application Number
Indian CDSCO WC-0082
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
DULOXETINE HYDROCHLORIDE USP
Duloxetine hydrochloride
Duloxetine Hydrochloride (Ph. Eur.)
Issue/Submission Date
2010-04-09
2018-11-29
2016-08-23
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DULOXETINE HYDROCHLORIDE USP (DUX P...
Issue/Submission Date
2016-03-31
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Duloxetine hydrochloride Process II
Issue/Submission Date
2017-01-16
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
VALID
 
Filing Details
DULOXETINE HYDROCHLORIDE USP (DUX P...
Duloxetine hydrochloride Process II
Issue/Submission Date
2016-03-31
2017-01-16
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
EMPAGLIFLOZIN
Issue/Submission Date
2017-11-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
EMPAGLIFLOZIN
Issue/Submission Date
2017-11-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2016-03-30
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ERLOTINIB HYDROCHLORIDE
Issue/Submission Date
2016-03-30
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERYTHROMYCIN USP
Issue/Submission Date
2009-03-27
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Erythromycin
Issue/Submission Date
2017-07-06
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Erythromycin (EP)
Issue/Submission Date
2017-03-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
VALID
 
Valid - 2019-07-02
Filing Details
ERYTHROMYCIN USP
Erythromycin
Erythromycin (EP)
Issue/Submission Date
2009-03-27
2017-07-06
2017-03-22
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ERYTHROMYCIN ETHYLSUCCINATE USP
Issue/Submission Date
2017-02-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ERYTHROMYCIN ETHYLSUCCINATE USP
Issue/Submission Date
2017-02-28
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
ETORICOXIB
Issue/Submission Date
2015-11-05
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0081
Status
Valid - 2019-07-02
Filing Details
Etoricoxib (IH)
Issue/Submission Date
2016-08-22
Supporting Info
Application Number
Indian CDSCO WC-0081
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-07-02
Filing Details
ETORICOXIB
Etoricoxib (IH)
Issue/Submission Date
2015-11-05
2016-08-22
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0083
Status
Valid - 2019-07-02
Filing Details
Etoricoxib
Issue/Submission Date
2016-07-19
Supporting Info
Application Number
Indian CDSCO WC-0083
Status
 
Valid - 2019-07-02
Filing Details
Etoricoxib
Issue/Submission Date
2016-07-19
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
FAMOTIDINE USP
Issue/Submission Date
2011-12-12