Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Aurobindo Pharma Limited

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Aurobindo Pharma Limited
india-flag Flag
Country
Country
India
Address
Address
Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
Telephone
Telephone
+91 (40) 6672 5000
Linkedin
Linkedin
Twitter
Twitter

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ListList of Products
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USDMF

Found USDMF

18965
Active
AMLODIPINE BESYLATE USP
2005-11-09
CEP/COS

Found CEP/COS

CEP 2006-130 - Rev 05
Valid
Amlodipine besilate
2023-11-29
Japanese DMF

Found JDMF

226MF10061
Amlodipine besylate at Plot No. 2, ...
2014-03-06
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Amlodipine sesilate EP
2022-07-15
Application Number
18965
226MF10061
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine besilate
Amlodipine besylate at Plot No. 2, ...
Amlodipine sesilate EP
Issue/Submission Date
2005-11-09
2023-11-29
2014-03-06
2022-07-15
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USDMF

Found USDMF

24116
Active
ATORVASTATIN CALCIUM USP
2010-09-27
CEP/COS

Found CEP/COS

CEP 2022-271 - Rev 01
Valid
Atorvastatin calcium, TBAH Sulphate...
2023-12-13
Japanese DMF

Found JDMF

226MF10048
Japanese Pharmacopoeia atorvastatin...
2014-02-20
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Atorvastatin Calcium Trihydrate EP
2022-07-15
Application Number
24116
226MF10048
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
ATORVASTATIN CALCIUM USP
Atorvastatin calcium, TBAH Sulphate...
Japanese Pharmacopoeia atorvastatin...
Atorvastatin Calcium Trihydrate EP
Issue/Submission Date
2010-09-27
2023-12-13
2014-02-20
2022-07-15
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USDMF

Found USDMF

29577
Active
DUTASTERIDE USP
2015-07-31
CEP/COS

Found CEP/COS

CEP 2014-306 - Rev 01
Valid
Dutasteride
2023-11-16
Japanese DMF

Found JDMF

231MF10062
Dutasteride at Plot No. 2, Maitrivi...
2019-03-04
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Dutasteride (Ph.Eur.)
2022-06-06
Application Number
29577
231MF10062
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
DUTASTERIDE USP
Dutasteride
Dutasteride at Plot No. 2, Maitrivi...
Dutasteride (Ph.Eur.)
Issue/Submission Date
2015-07-31
2023-11-16
2019-03-04
2022-06-06
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USDMF

Found USDMF

24188
Active
ENTACAPONE USP (NON-STERILE DRUG SU...
2010-09-27
CEP/COS

Found CEP/COS

CEP 2010-325 - Rev 03
Valid
Entacapone
2023-12-13
Japanese DMF

Found JDMF

227MF10029
Entacapone at Plot No. 2, Maitrivih...
2015-01-23
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Entacapone
2022-07-15
Application Number
24188
227MF10029
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
ENTACAPONE USP (NON-STERILE DRUG SU...
Entacapone
Entacapone at Plot No. 2, Maitrivih...
Entacapone
Issue/Submission Date
2010-09-27
2023-12-13
2015-01-23
2022-07-15
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USDMF

Found USDMF

19308
Active
FINASTERIDE USP
2006-03-27
CEP/COS

Found CEP/COS

CEP 2006-254 - Rev 05
Valid
Finasteride
2023-11-16
Japanese DMF

Found JDMF

227MF10088
Finasteride at Plot No. 2, Maitrivi...
2015-03-12
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Finasteride (Ph.Eur.)
2022-06-06
Application Number
19308
227MF10088
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
FINASTERIDE USP
Finasteride
Finasteride at Plot No. 2, Maitrivi...
Finasteride (Ph.Eur.)
Issue/Submission Date
2006-03-27
2023-11-16
2015-03-12
2022-06-06
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USDMF

Found USDMF

17728
Active
HYDROCHLOROTHIAZIDE USP
2004-09-24
CEP/COS

Found CEP/COS

CEP 2005-013 - Rev 06
Valid
Hydrochlorothiazide
2023-11-16
Japanese DMF

Found JDMF

224MF10214
Hydrochlorothiazide at Plot No. 2, ...
2012-11-08
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Hydrochlorothiazide (Ph.Eur)
2022-06-06
Application Number
17728
224MF10214
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
HYDROCHLOROTHIAZIDE USP
Hydrochlorothiazide
Hydrochlorothiazide at Plot No. 2, ...
Hydrochlorothiazide (Ph.Eur)
Issue/Submission Date
2004-09-24
2023-11-16
2012-11-08
2022-06-06
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USDMF

Found USDMF

23084
Active
IRBESARTAN USP (NON-STERILE DRUG SU...
2009-08-31
CEP/COS

Found CEP/COS

CEP 2021-297 - Rev 01
Valid
Irbesartan, Process II
2023-12-13
Japanese DMF

Found JDMF

228MF10097
Japanese Pharmacopoeia irbesartan a...
2016-05-16
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Irbesartan Ph.Eur
2022-07-15
Application Number
23084
228MF10097
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
IRBESARTAN USP (NON-STERILE DRUG SU...
Irbesartan, Process II
Japanese Pharmacopoeia irbesartan a...
Irbesartan Ph.Eur
Issue/Submission Date
2009-08-31
2023-12-13
2016-05-16
2022-07-15
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USDMF

Found USDMF

19671
Active
LOSARTAN POTASSIUM USP DRUG SUBSTAN...
2006-08-05
CEP/COS

Found CEP/COS

CEP 2009-334 - Rev 06
Valid
Losartan potassium
2023-12-13
Japanese DMF

Found JDMF

224MF10221
Losartan potassium at Plot No. 2, M...
2012-11-26
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Losartan Potassium (Ph. Eur./USP)
2022-07-15
Application Number
19671
224MF10221
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
LOSARTAN POTASSIUM USP DRUG SUBSTAN...
Losartan potassium
Losartan potassium at Plot No. 2, M...
Losartan Potassium (Ph. Eur./USP)
Issue/Submission Date
2006-08-05
2023-12-13
2012-11-26
2022-07-15
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USDMF

Found USDMF

23525
Active
OLANZAPINE USP (NON-STERILE DRUG SU...
2010-02-03
CEP/COS

Found CEP/COS

CEP 2011-294 - Rev 01
Valid
Olanzapine
2023-11-16
Japanese DMF

Found JDMF

226MF10179
Olanzapine at Plot No. 2, Maitrivih...
2014-09-01
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Olanzapine (Ph.Eur)
2022-06-06
Application Number
23525
226MF10179
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
OLANZAPINE USP (NON-STERILE DRUG SU...
Olanzapine
Olanzapine at Plot No. 2, Maitrivih...
Olanzapine (Ph.Eur)
Issue/Submission Date
2010-02-03
2023-11-16
2014-09-01
2022-06-06
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USDMF

Found USDMF

19484
Active
PERINDOPRIL TERT-BUTYLAMINE DRUG SU...
2006-05-31
CEP/COS

Found CEP/COS

CEP 2008-009 - Rev 05
Valid
Perindopril tert-butylamine
2024-01-17
Japanese DMF

Found JDMF

227MF10018
Bae Lind erbumine at Plot No. 2, Ma...
2015-01-05
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Perindopril tert-Butylamine (Ph. Eu...
2022-07-15
Application Number
19484
227MF10018
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
PERINDOPRIL TERT-BUTYLAMINE DRUG SU...
Perindopril tert-butylamine
Bae Lind erbumine at Plot No. 2, Ma...
Perindopril tert-Butylamine (Ph. Eu...
Issue/Submission Date
2006-05-31
2024-01-17
2015-01-05
2022-07-15
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USDMF

Found USDMF

22789
Active
PRAMIPEXOLE DIHYDROCHLORIDE USP
2009-05-15
CEP/COS

Found CEP/COS

CEP 2009-292 - Rev 03
Valid
Pramipexole dihydrochloride monohyd...
2023-11-16
Japanese DMF

Found JDMF

223MF10156
Pramipexole hydrochloride hydrate a...
2011-11-02
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Pramipexole Dihydrochloride monohyd...
2022-06-06
Application Number
22789
223MF10156
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE USP
Pramipexole dihydrochloride monohyd...
Pramipexole hydrochloride hydrate a...
Pramipexole Dihydrochloride monohyd...
Issue/Submission Date
2009-05-15
2023-11-16
2011-11-02
2022-06-06
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USDMF

Found USDMF

17435
Active
SERTRALINE HYDROCHLORIDE USP (CRYST...
2004-05-31
CEP/COS

Found CEP/COS

CEP 2008-019 - Rev 05
Valid
Sertraline hydrochloride, Form I
2024-02-07
Japanese DMF

Found JDMF

226MF10098
Sertraline hydrochloride at Plot No...
2014-05-14
Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Sertraline Hydrochloride (Ph.Eur.)
2022-06-06
Application Number
17435
226MF10098
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
SERTRALINE HYDROCHLORIDE USP (CRYST...
Sertraline hydrochloride, Form I
Sertraline hydrochloride at Plot No...
Sertraline Hydrochloride (Ph.Eur.)
Issue/Submission Date
2004-05-31
2024-02-07
2014-05-14
2022-06-06
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USDMF

Found USDMF

18192
Active
TERBINAFINE HYDROCHLORIDE USP
2005-03-11
CEP/COS

Found CEP/COS

CEP 2007-146 - Rev 07
Valid
Terbinafine hydrochloride
2024-03-05
Japanese DMF

Found JDMF

223MF10017
Terbinafine hydrochloride at Plot N...
2011-02-03
Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Terbinafine Hydrochloride (BP/Ph. E...
2022-07-15
Application Number
18192
223MF10017
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
TERBINAFINE HYDROCHLORIDE USP
Terbinafine hydrochloride
Terbinafine hydrochloride at Plot N...
Terbinafine Hydrochloride (BP/Ph. E...
Issue/Submission Date
2005-03-11
2024-03-05
2011-02-03
2022-07-15
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USDMF

Found USDMF

20211
Active
AMPICILLIN SODIUM USP (STERILE) BUL...
2007-01-16
CEP/COS

Found CEP/COS

CEP 2008-001 - Rev 06
Valid
Ampicillin sodium, Sterile
2024-01-19
Japanese DMF

Found JDMF

302MF10023
Ampicillin sodium (sterile) at Plot...
2020-02-06
Written Confirmation

Caution WC

Indian CDSCO WC-0121
Expired
Ampicillin Sodium Sterile (Ph. Eur)
2019-07-05
Application Number
20211
302MF10023
Indian CDSCO WC-0121
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
AMPICILLIN SODIUM USP (STERILE) BUL...
Ampicillin sodium, Sterile
Ampicillin sodium (sterile) at Plot...
Ampicillin Sodium Sterile (Ph. Eur)
Issue/Submission Date
2007-01-16
2024-01-19
2020-02-06
2019-07-05
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USDMF

Found USDMF

26239
Active
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
2012-08-01
CEP/COS

Found CEP/COS

CEP 2014-255 - Rev 01
Valid
Esomeprazole magnesium dihydrate
2024-01-11
Japanese DMF

Found JDMF

303MF10137
esomeprazole magnesium hydrate at P...
2021-08-20
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Esomeprazole Magnesium Dihydrate (I...
2019-06-26
Application Number
26239
303MF10137
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Esomeprazole magnesium dihydrate
esomeprazole magnesium hydrate at P...
Esomeprazole Magnesium Dihydrate (I...
Issue/Submission Date
2012-08-01
2024-01-11
2021-08-20
2019-06-26
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USDMF

Found USDMF

19908
Active
LAMOTRIGINE USP (NON-STERILE DRUG S...
2006-10-26
CEP/COS

Found CEP/COS

CEP 2008-010 - Rev 05
Valid
Lamotrigine
2024-01-05
Japanese DMF

Found JDMF

229MF10046
Lamotrigine at Plot No. 2, Maitrivi...
2017-02-20
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Lamotrigine (Ph. Eur)
2019-06-26
Application Number
19908
229MF10046
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
LAMOTRIGINE USP (NON-STERILE DRUG S...
Lamotrigine
Lamotrigine at Plot No. 2, Maitrivi...
Lamotrigine (Ph. Eur)
Issue/Submission Date
2006-10-26
2024-01-05
2017-02-20
2019-06-26
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USDMF

Found USDMF

26035
Active
OLMESARTAN MEDOXOMIL USP
2012-06-01
CEP/COS

Found CEP/COS

CEP 2020-112 - Rev 03
Valid
Olmesartan medoxomil, Process II
2024-01-11
Japanese DMF

Found JDMF

228MF10154
Japanese Pharmacopoeia olmesartan m...
2016-08-08
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Olmesartan Medoxomil (Ph. Eur)
2019-06-26
Application Number
26035
228MF10154
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
OLMESARTAN MEDOXOMIL USP
Olmesartan medoxomil, Process II
Japanese Pharmacopoeia olmesartan m...
Olmesartan Medoxomil (Ph. Eur)
Issue/Submission Date
2012-06-01
2024-01-11
2016-08-08
2019-06-26
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USDMF

Found USDMF

25650
Active
RALOXIFENE HYDROCHLORIDE USP (NON-S...
2012-01-10
CEP/COS

Found CEP/COS

CEP 2012-016 - Rev 02
Valid
Raloxifene hydrochloride
2024-01-05
Japanese DMF

Found JDMF

228MF10113
Raloxifene hydrochloride at Plot No...
2016-06-17
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Raloxifene Rizatriptan ro Hydchlori...
2019-06-26
Application Number
25650
228MF10113
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
RALOXIFENE HYDROCHLORIDE USP (NON-S...
Raloxifene hydrochloride
Raloxifene hydrochloride at Plot No...
Raloxifene Rizatriptan ro Hydchlori...
Issue/Submission Date
2012-01-10
2024-01-05
2016-06-17
2019-06-26
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USDMF

Found USDMF

21688
Active
VALACYCLOVIR HYDROCHLORIDE USP (NON...
2008-06-07
CEP/COS

Found CEP/COS

CEP 2013-318 - Rev 02
Valid
Valaciclovir hydrochloride hydrate
2024-02-02
Japanese DMF

Found JDMF

224MF10090
Valacyclovir hydrochloride hydrate ...
2012-04-25
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Valaciclovir Hydrochloride Hydrate ...
2019-06-26
Application Number
21688
224MF10090
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
VALACYCLOVIR HYDROCHLORIDE USP (NON...
Valaciclovir hydrochloride hydrate
Valacyclovir hydrochloride hydrate ...
Valaciclovir Hydrochloride Hydrate ...
Issue/Submission Date
2008-06-07
2024-02-02
2012-04-25
2019-06-26
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USDMF

Found USDMF

27502
Active
ZOLMITRIPTAN
2013-09-19
CEP/COS

Found CEP/COS

CEP 2018-177 - Rev 02
Valid
Zolmitriptan
2024-01-11
Japanese DMF

Found JDMF

226MF10010
Zolmitriptan at Plot No. 2, Maitriv...
2014-01-08
Written Confirmation

Caution WC

Indian CDSCO WC-0023
Expired
Zolmitriptan(Ph.Eur)
2019-06-26
Application Number
27502
226MF10010
Indian CDSCO WC-0023
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
ZOLMITRIPTAN
Zolmitriptan
Zolmitriptan at Plot No. 2, Maitriv...
Zolmitriptan(Ph.Eur)
Issue/Submission Date
2013-09-19
2024-01-11
2014-01-08
2019-06-26
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USDMF

Found USDMF

19013
Active
BENAZEPRIL HYDROCHLORIDE USP
2005-11-28
CEP/COS

Found CEP/COS

CEP 2008-232 - Rev 03
Valid
Benazepril hydrochloride
2023-11-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Benazepril Hydrochloride (Ph.Eur.)
2022-06-06
Application Number
19013
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Benazepril hydrochloride
Benazepril Hydrochloride (Ph.Eur.)
Issue/Submission Date
2005-11-28
2023-11-16
2022-06-06
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USDMF

Found USDMF

18781
Active
BISOPROLOL FUMARATE USP
2005-09-12
CEP/COS

Found CEP/COS

CEP 2007-336 - Rev 04
Valid
Bisoprolol fumarate
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Bisoprolol Fumarate (EP/USP)
2022-07-15
Application Number
18781
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
BISOPROLOL FUMARATE USP
Bisoprolol fumarate
Bisoprolol Fumarate (EP/USP)
Issue/Submission Date
2005-09-12
2023-12-13
2022-07-15
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USDMF

Found USDMF

19106
Active
CARVEDILOL USP
2006-01-06
CEP/COS

Found CEP/COS

CEP 2006-136 - Rev 06
Valid
Carvedilol
2023-11-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Carvedilol (Ph. Eur.)
2022-06-06
Application Number
19106
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
CARVEDILOL USP
Carvedilol
Carvedilol (Ph. Eur.)
Issue/Submission Date
2006-01-06
2023-11-17
2022-06-06
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USDMF

Found USDMF

18331
Active
CEFADROXIL USP
2005-04-30
CEP/COS

Found CEP/COS

CEP 2006-203 - Rev 03
Valid
Cefadroxil monohydrate
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Cefadroxil Monohydrate (BP/EP/USP)
2022-07-15
Application Number
18331
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
CEFADROXIL USP
Cefadroxil monohydrate
Cefadroxil Monohydrate (BP/EP/USP)
Issue/Submission Date
2005-04-30
2023-12-13
2022-07-15
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USDMF

Found USDMF

18469
Active
CEFPROZIL USP
2005-06-28
CEP/COS

Found CEP/COS

CEP 2013-092 - Rev 01
Valid
Cefprozil monohydrate
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Cefprozil Monohydrate EP
2022-07-15
Application Number
18469
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
CEFPROZIL USP
Cefprozil monohydrate
Cefprozil Monohydrate EP
Issue/Submission Date
2005-06-28
2023-12-13
2022-07-15
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USDMF

Found USDMF

17707
Active
CEFUROXIME AXETIL USP
2004-09-20
CEP/COS

Found CEP/COS

CEP 2002-252 - Rev 07
Valid
Cefuroxime axetil
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Cefuroxime Axetil (BP/Ph. Eur./USP)...
2022-07-15
Application Number
17707
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
CEFUROXIME AXETIL USP
Cefuroxime axetil
Cefuroxime Axetil (BP/Ph. Eur./USP)...
Issue/Submission Date
2004-09-20
2023-12-13
2022-07-15
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USDMF

Found USDMF

18558
Active
CIPROFLOXACIN HYDROCHLORIDE USP
2005-07-25
CEP/COS

Found CEP/COS

R1-CEP 2005-106 - Rev 02
Valid
Ciprofloxacin Hydrochloride
2017-11-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Ciprofloxacin Hydrochloride (EP/BP/...
2022-07-15
Application Number
18558
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
CIPROFLOXACIN HYDROCHLORIDE USP
Ciprofloxacin Hydrochloride
Ciprofloxacin Hydrochloride (EP/BP/...
Issue/Submission Date
2005-07-25
2017-11-06
2022-07-15
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USDMF

Found USDMF

16850
Active
CITALOPRAM HYDROBROMIDE USP
2003-09-19
CEP/COS

Found CEP/COS

CEP 2009-043 - Rev 02
Valid
Citalopram hydrobromide
2024-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Citalopram Hydrobromide (USP)
2022-07-15
Application Number
16850
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
CITALOPRAM HYDROBROMIDE USP
Citalopram hydrobromide
Citalopram Hydrobromide (USP)
Issue/Submission Date
2003-09-19
2024-01-03
2022-07-15
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USDMF

Found USDMF

19088
Active
ESCITALOPRAM OXALATE USP
2005-12-24
CEP/COS

Found CEP/COS

CEP 2017-140 - Rev 01
Valid
Escitalopram oxalate
2024-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Escitalopram Sodium (IH)
2022-07-15
Application Number
19088
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
ESCITALOPRAM OXALATE USP
Escitalopram oxalate
Escitalopram Sodium (IH)
Issue/Submission Date
2005-12-24
2024-01-03
2022-07-15
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USDMF

Found USDMF

18176
Active
FLUCONAZOLE USP
2005-02-28
CEP/COS

Found CEP/COS

CEP 2007-071 - Rev 05
Valid
Fluconazole
2023-11-21
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Fluconazole (Ph.Eur.)
2022-06-06
Application Number
18176
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
FLUCONAZOLE USP
Fluconazole
Fluconazole (Ph.Eur.)
Issue/Submission Date
2005-02-28
2023-11-21
2022-06-06
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USDMF

Found USDMF

18980
Active
FLUOXETINE HYDROCHLORIDE USP
2005-11-23
CEP/COS

Found CEP/COS

CEP 2019-226 - Rev 03
Valid
Fluoxetine hydrochloride, Process I...
2023-11-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Fluoxetine Hydrochloride (Ph.Eur.)
2022-06-06
Application Number
18980
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
FLUOXETINE HYDROCHLORIDE USP
Fluoxetine hydrochloride, Process I...
Fluoxetine Hydrochloride (Ph.Eur.)
Issue/Submission Date
2005-11-23
2023-11-16
2022-06-06
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USDMF

Found USDMF

17152
Active
GLYBURIDE USP
2004-01-20
CEP/COS

Found CEP/COS

CEP 2004-192 - Rev 06
Valid
Glibenclamide
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Galibenclamide (EP/BP)
2022-07-15
Application Number
17152
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
GLYBURIDE USP
Glibenclamide
Galibenclamide (EP/BP)
Issue/Submission Date
2004-01-20
2023-12-13
2022-07-15
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USDMF

Found USDMF

18921
Active
MELOXICAM USP
2005-10-24
CEP/COS

Found CEP/COS

CEP 2008-061 - Rev 03
Valid
Meloxicam
2023-11-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Meloxicam (Ph.Eur)
2022-06-06
Application Number
18921
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
MELOXICAM USP
Meloxicam
Meloxicam (Ph.Eur)
Issue/Submission Date
2005-10-24
2023-11-16
2022-06-06
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USDMF

Found USDMF

16993
Active
METFORMIN HYDROCHLORIDE USP
2003-12-01
CEP/COS

Found CEP/COS

CEP 2004-088 - Rev 08
Valid
Metformin Hydrochloride
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Metformin Hydrochloride (BP/Ph. Eur...
2022-07-15
Application Number
16993
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
METFORMIN HYDROCHLORIDE USP
Metformin Hydrochloride
Metformin Hydrochloride (BP/Ph. Eur...
Issue/Submission Date
2003-12-01
2023-12-13
2022-07-15
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USDMF

Found USDMF

19281
Active
METOPROLOL SUCCINATE USP
2006-03-17
CEP/COS

Found CEP/COS

CEP 2007-037 - Rev 05
Valid
Metoprolol succinate
2024-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Metoprolol Succinate (BP/EP/USP)
2022-07-15
Application Number
19281
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
METOPROLOL SUCCINATE USP
Metoprolol succinate
Metoprolol Succinate (BP/EP/USP)
Issue/Submission Date
2006-03-17
2024-01-03
2022-07-15
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USDMF

Found USDMF

19283
Active
METOPROLOL TARTRATE USP
2006-03-21
CEP/COS

Found CEP/COS

CEP 2007-057 - Rev 04
Valid
Metoprolol tartrate
2024-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Metoprolol Tartrate (EP/BP/USP)
2022-07-15
Application Number
19283
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
METOPROLOL TARTRATE USP
Metoprolol tartrate
Metoprolol Tartrate (EP/BP/USP)
Issue/Submission Date
2006-03-21
2024-01-03
2022-07-15
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USDMF

Found USDMF

16490
Active
MIRTAZAPINE ANHYDROUS USP
2003-03-28
CEP/COS

Found CEP/COS

CEP 2007-062 - Rev 04
Valid
Mirtazapine
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Mirtazapine (Ph. Eur./USP)
2022-07-15
Application Number
16490
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
MIRTAZAPINE ANHYDROUS USP
Mirtazapine
Mirtazapine (Ph. Eur./USP)
Issue/Submission Date
2003-03-28
2023-12-13
2022-07-15
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USDMF

Found USDMF

17851
Active
NEVIRAPINE ANHYDROUS USP
2004-11-16
CEP/COS

Found CEP/COS

CEP 2012-184 - Rev 02
Valid
Nevirapine, Process II
2024-01-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Nevirapine EP
2022-07-15
Application Number
17851
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
NEVIRAPINE ANHYDROUS USP
Nevirapine, Process II
Nevirapine EP
Issue/Submission Date
2004-11-16
2024-01-12
2022-07-15
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USDMF

Found USDMF

19152
Active
PAROXETINE HYDROCHLORIDE (HEMIHYDRA...
2006-01-30
CEP/COS

Found CEP/COS

CEP 2006-206 - Rev 04
Valid
Paroxetine hydrochloride hemihydrat...
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Paroxetine Hydrochoride Hemihydrate...
2022-07-15
Application Number
19152
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
PAROXETINE HYDROCHLORIDE (HEMIHYDRA...
Paroxetine hydrochloride hemihydrat...
Paroxetine Hydrochoride Hemihydrate...
Issue/Submission Date
2006-01-30
2023-12-13
2022-07-15
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USDMF

Found USDMF

19265
Active
PIPERACILLIN USP
2006-03-15
CEP/COS

Found CEP/COS

CEP 2019-052 - Rev 03
Valid
Piperacillin monohydrate
2023-11-30
Japanese DMF

Found JDMF

229MF10208
Piperacillin hydrate (production on...
2017-11-30
Written Confirmation

Close WC

Application Number
19265
229MF10208
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PIPERACILLIN USP
Piperacillin monohydrate
Piperacillin hydrate (production on...
Issue/Submission Date
2006-03-15
2023-11-30
2017-11-30
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USDMF

Found USDMF

19046
Active
QUINAPRIL HYDROCHLORIDE USP
2005-11-30
CEP/COS

Found CEP/COS

CEP 2013-160 - Rev 02
Valid
Quinapril hydrochloride
2023-11-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Quinapril Hydrochloride (Ph.Eur)
2022-06-06
Application Number
19046
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
QUINAPRIL HYDROCHLORIDE USP
Quinapril hydrochloride
Quinapril Hydrochloride (Ph.Eur)
Issue/Submission Date
2005-11-30
2023-11-16
2022-06-06
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USDMF

Found USDMF

19186
Active
RABEPRAZOLE SODIUM
2006-01-31
CEP/COS

Found CEP/COS

CEP 2017-253 - Rev 01
Valid
Rabeprazole sodium hydrate
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Rabeprazole Sodium (IH)
2022-07-15
Application Number
19186
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
RABEPRAZOLE SODIUM
Rabeprazole sodium hydrate
Rabeprazole Sodium (IH)
Issue/Submission Date
2006-01-31
2023-12-13
2022-07-15
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USDMF

Found USDMF

17570
Active
RAMIPRIL USP
2004-07-16
CEP/COS

Found CEP/COS

CEP 2004-222 - Rev 05
Valid
Ramipril
2023-11-14
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Ramipril (Ph.Eur)
2022-06-06
Application Number
17570
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
RAMIPRIL USP
Ramipril
Ramipril (Ph.Eur)
Issue/Submission Date
2004-07-16
2023-11-14
2022-06-06
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USDMF

Found USDMF

18973
Active
RIBAVIRIN USP
2005-11-23
CEP/COS

Found CEP/COS

CEP 2007-013 - Rev 05
Valid
Ribavirin
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Ribavirin (EP)
2022-07-15
Application Number
18973
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
RIBAVIRIN USP
Ribavirin
Ribavirin (EP)
Issue/Submission Date
2005-11-23
2023-12-13
2022-07-15
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USDMF

Found USDMF

18120
Active
RISPERIDONE USP
2005-02-18
CEP/COS

Found CEP/COS

CEP 2005-094 - Rev 03
Valid
Risperidone
2023-12-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Risperidone (Ph. Eur)
2022-07-15
Application Number
18120
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
RISPERIDONE USP
Risperidone
Risperidone (Ph. Eur)
Issue/Submission Date
2005-02-18
2023-12-13
2022-07-15
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USDMF

Found USDMF

19037
Active
RITONAVIR USP
2005-12-09
CEP/COS

Found CEP/COS

CEP 2018-061 - Rev 01
Valid
Ritonavir
2024-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Ritonavir (EP)
2022-07-15
Application Number
19037
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
RITONAVIR USP
Ritonavir
Ritonavir (EP)
Issue/Submission Date
2005-12-09
2024-01-03
2022-07-15
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USDMF

Found USDMF

17829
Active
SIMVASTATIN USP
2004-11-08
CEP/COS

Found CEP/COS

R1-CEP 2005-159 - Rev 03
Valid
Simvastatin
2019-03-29
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Simvastatin (EP)
2022-07-15
Application Number
17829
Indian CDSCO WC-0120
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
SIMVASTATIN USP
Simvastatin
Simvastatin (EP)
Issue/Submission Date
2004-11-08
2019-03-29
2022-07-15
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USDMF

Found USDMF

19247
Active
TOPIRAMATE USP
2006-03-04
CEP/COS

Found CEP/COS

CEP 2020-140 - Rev 03
Valid
Topiramate
2023-12-18
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0120
Valid
Topiramate (USP)
2022-07-15
Application Number
19247
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
TOPIRAMATE USP
Topiramate
Topiramate (USP)
Issue/Submission Date
2006-03-04
2023-12-18
2022-07-15
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USDMF

Found USDMF

17638
Active
ZIDOVUDINE USP
2004-08-18
CEP/COS

Found CEP/COS

CEP 2005-063 - Rev 05
Valid
Zidovudine
2023-11-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Zidovudine (Ph.Eur.)
2022-06-06
Application Number
17638
Indian CDSCO WC-0017
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-10
Filing Details
ZIDOVUDINE USP
Zidovudine
Zidovudine (Ph.Eur.)
Issue/Submission Date
2004-08-18
2023-11-28
2022-06-06
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USDMF

Found USDMF

18974
Active
ZOLPIDEM TARTRATE USP
2005-11-16
CEP/COS

Found CEP/COS

CEP 2006-276 - Rev 04
Valid
Zolpidem tartrate
2023-11-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0017
Valid
Zolpidem Tartrate (Ph.Eur.)
2022-06-06
Application Number
18974
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-10
Filing Details
ZOLPIDEM TARTRATE USP
Zolpidem tartrate
Zolpidem Tartrate (Ph.Eur.)
Issue/Submission Date
2005-11-16
2023-11-16
2022-06-06
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