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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by MSN Laboratories

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MSN Laboratories
india-flag Flag
Country
Country
India
Address
Address
MSN House Plot No: C-24 Industrial Estate, Sanathnagar Hyderabad - 18 Telangana
Telephone
Telephone
+91 40 30438600
Linkedin
Linkedin
Twitter
Twitter

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USDMF

Found USDMF

20996
Active
DULOXETINE HYDROCHLORIDE USP [ROUTE...
2007-10-30
CEP/COS

Found CEP/COS

CEP 2021-314 - Rev 00
Valid
Duloxetine hydrochloride, Route cod...
2023-12-06
Japanese DMF

Found JDMF

229MF10088
Duloxetine hydrochloride at Plot No...
2017-04-26
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Duloxetine Hydrochloride USP/EP
2022-06-17
Application Number
20996
229MF10088
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DULOXETINE HYDROCHLORIDE USP [ROUTE...
Duloxetine hydrochloride, Route cod...
Duloxetine hydrochloride at Plot No...
Duloxetine Hydrochloride USP/EP
Issue/Submission Date
2007-10-30
2023-12-06
2017-04-26
2022-06-17
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USDMF

Found USDMF

23533
Active
DUTASTERIDE USP [ROUTE CODE - "DT"]
2010-02-16
CEP/COS

Found CEP/COS

R1-CEP 2014-019 - Rev 00
Valid
Dutasteride
2020-08-31
Japanese DMF

Found JDMF

230MF10024
Dutasteride at Plot No: C-24, Sanat...
2018-02-14
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Dutasteride IH/USP/EP
2022-06-17
Application Number
23533
230MF10024
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DUTASTERIDE USP [ROUTE CODE - "DT"]
Dutasteride
Dutasteride at Plot No: C-24, Sanat...
Dutasteride IH/USP/EP
Issue/Submission Date
2010-02-16
2020-08-31
2018-02-14
2022-06-17
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USDMF

Found USDMF

21523
Active
VORICONAZOLE USP [ROUTE CODE - "VZ"...
2008-04-08
CEP/COS

Found CEP/COS

R1-CEP 2011-387 - Rev 01
Valid
Voriconazole
2023-06-29
Japanese DMF

Found JDMF

230MF10097
Voriconazole at Plot No: C-24, Sana...
2018-08-02
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Voriconazole EP/USP
2022-06-17
Application Number
21523
230MF10097
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
VORICONAZOLE USP [ROUTE CODE - "VZ"...
Voriconazole
Voriconazole at Plot No: C-24, Sana...
Voriconazole EP/USP
Issue/Submission Date
2008-04-08
2023-06-29
2018-08-02
2022-06-17
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USDMF

Found USDMF

23889
Active
OSELTAMIVIR PHOSPHATE [ROUTE CODE -...
2010-06-15
CEP/COS

Found CEP/COS

CEP 2012-067 - Rev 02
Valid
Oseltamivir phosphate
2023-10-24
Japanese DMF

Found JDMF

229MF10042
Oseltamivir phosphate at Plot No: C...
2017-02-15
Written Confirmation

Caution WC

Indian CDSCO WC-0022
Expired
Oseltamivir Phosphate (Ph. Eur)
2019-08-16
Application Number
23889
229MF10042
Indian CDSCO WC-0022
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
OSELTAMIVIR PHOSPHATE [ROUTE CODE -...
Oseltamivir phosphate
Oseltamivir phosphate at Plot No: C...
Oseltamivir Phosphate (Ph. Eur)
Issue/Submission Date
2010-06-15
2023-10-24
2017-02-15
2019-08-16
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USDMF

Found USDMF

24181
Active
PIOGLITAZONE HYDROCHLORIDE USP [ROU...
2010-09-15
CEP/COS

Found CEP/COS

R1-CEP 2013-005 - Rev 00
Valid
Pioglitazone hydrochloride
2019-02-20
Japanese DMF

Found JDMF

301MF10024
Pioglitazone Hydrochloride at Plot ...
2019-06-28
Written Confirmation

Caution WC

Indian CDSCO WC-0281new2
Expired
Pioglitazone Hydrochloride USP/EP
2020-04-15
Application Number
24181
301MF10024
Indian CDSCO WC-0281new2
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2023-05-19
Filing Details
PIOGLITAZONE HYDROCHLORIDE USP [ROU...
Pioglitazone hydrochloride
Pioglitazone Hydrochloride at Plot ...
Pioglitazone Hydrochloride USP/EP
Issue/Submission Date
2010-09-15
2019-02-20
2019-06-28
2020-04-15
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USDMF

Found USDMF

27829
Active
ABIRATERONE ACETATE USP [ROUTE CODE...
2013-12-24
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10113
Abiraterone Acetate USP at Plot No:...
2022-08-03
Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Abiraterone IH/Abiraterone Acetate ...
2022-09-02
Application Number
27829
304MF10113
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
 
Valid
2025-05-05
Filing Details
ABIRATERONE ACETATE USP [ROUTE CODE...
Abiraterone Acetate USP at Plot No:...
Abiraterone IH/Abiraterone Acetate ...
Issue/Submission Date
2013-12-24
2022-08-03
2022-09-02
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USDMF

Found USDMF

20867
Active
ALFUZOSIN HYDROCHLORIDE USP [ROUTE ...
2007-09-17
CEP/COS

Found CEP/COS

CEP 2006-208 - Rev 06
Valid
Alfuzosin hydrochloride
2024-01-31
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Alfuzosin Hydrochloride USP/EP
2022-06-17
Application Number
20867
Indian CDSCO WC-0021n
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-14
Filing Details
ALFUZOSIN HYDROCHLORIDE USP [ROUTE ...
Alfuzosin hydrochloride
Alfuzosin Hydrochloride USP/EP
Issue/Submission Date
2007-09-17
2024-01-31
2022-06-17
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USDMF

Found USDMF

25327
Active
ALMOTRIPTAN MALATE USP [ROUTE CODE...
2011-09-24
CEP/COS

Found CEP/COS

R0-CEP 2020-253 - Rev 00
Valid
Almotriptan malate
2022-01-25
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Almotriptan Malate IH/Almotriptan M...
2022-06-17
Application Number
25327
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
ALMOTRIPTAN MALATE USP [ROUTE CODE...
Almotriptan malate
Almotriptan Malate IH/Almotriptan M...
Issue/Submission Date
2011-09-24
2022-01-25
2022-06-17
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USDMF

Found USDMF

26156
Active
AMBRISENTAN [ROUTE CODE - AB]
2012-06-08
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

302MF10087
Ambrisentan at Plot No: C-24, Sanat...
2020-07-22
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Ambrisentan IH
2022-06-17
Application Number
26156
302MF10087
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-14
Filing Details
AMBRISENTAN [ROUTE CODE - AB]
Ambrisentan at Plot No: C-24, Sanat...
Ambrisentan IH
Issue/Submission Date
2012-06-08
2020-07-22
2022-06-17
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USDMF

Found USDMF

25356
Active
AZELASTINE HYDROCHLORIDE USP [ROUTE...
2011-10-04
CEP/COS

Found CEP/COS

R1-CEP 2011-363 - Rev 01
Valid
Azelastine hydrochloride
2022-06-01
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Azelastine Hydrochloride EP/USP
2022-06-17
Application Number
25356
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
AZELASTINE HYDROCHLORIDE USP [ROUTE...
Azelastine hydrochloride
Azelastine Hydrochloride EP/USP
Issue/Submission Date
2011-10-04
2022-06-01
2022-06-17
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USDMF

Found USDMF

25730
Active
BICALUTAMIDE USP [ROUTE CODE - "BL"...
2012-01-24
CEP/COS

Found CEP/COS

R1-CEP 2012-283 - Rev 01
Valid
Bicalutamide
2023-08-10
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Bicalutamide (Ph.Eur/USP)
2022-09-02
Application Number
25730
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
BICALUTAMIDE USP [ROUTE CODE - "BL"...
Bicalutamide
Bicalutamide (Ph.Eur/USP)
Issue/Submission Date
2012-01-24
2023-08-10
2022-09-02
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USDMF

Found USDMF

33915
Active
BUMETANIDE USP
2019-06-28
CEP/COS

Found CEP/COS

R0-CEP 2020-151 - Rev 00
Valid
Bumetanide
2022-03-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Bumetanide IH
2022-06-17
Application Number
33915
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
BUMETANIDE USP
Bumetanide
Bumetanide IH
Issue/Submission Date
2019-06-28
2022-03-22
2022-06-17
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USDMF

Found USDMF

26078
Active
CAPECITABINE USP [ROUTE CODE - "CT"...
2012-05-22
CEP/COS

Found CEP/COS

R1-CEP 2015-391 - Rev 02
Valid
Capecitabine
2023-08-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Capecitabine (USP)
2022-09-02
Application Number
26078
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
CAPECITABINE USP [ROUTE CODE - "CT"...
Capecitabine
Capecitabine (USP)
Issue/Submission Date
2012-05-22
2023-08-16
2022-09-02
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USDMF

Found USDMF

27865
Active
CARBOPROST TROMETHAMINE USP [ROUTE ...
2014-01-27
CEP/COS

Found CEP/COS

R0-CEP 2021-354 - Rev 00
Valid
Carboprost trometamol
2023-08-29
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Carboprost Tromethamine (USP)
2022-09-02
Application Number
27865
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
CARBOPROST TROMETHAMINE USP [ROUTE ...
Carboprost trometamol
Carboprost Tromethamine (USP)
Issue/Submission Date
2014-01-27
2023-08-29
2022-09-02
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USDMF

Found USDMF

31156
Active
CARMUSTINE USP
2016-12-30
CEP/COS

Found CEP/COS

R0-CEP 2017-231 - Rev 03
Valid
Carmustine
2023-08-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Carmustine USP
2022-09-02
Application Number
31156
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
CARMUSTINE USP
Carmustine
Carmustine USP
Issue/Submission Date
2016-12-30
2023-08-16
2022-09-02
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USDMF

Found USDMF

35806
Active
CLADRIBINE USP
2021-03-31
CEP/COS

Found CEP/COS

R0-CEP 2021-217 - Rev 01
Valid
Cladribine
2023-08-11
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Cladribine USP/Ph.Eur.
2022-09-02
Application Number
35806
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
CLADRIBINE USP
Cladribine
Cladribine USP/Ph.Eur.
Issue/Submission Date
2021-03-31
2023-08-11
2022-09-02
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USDMF

Found USDMF

21309
Active
CLOPIDOGREL BISULFATE USP (FORM-1) ...
2008-02-04
CEP/COS

Found CEP/COS

R1-CEP 2015-331 - Rev 00
Valid
Clopidogrel hydrogen sulfate, Form ...
2022-01-26
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Clopidogrel Hydrogen Sulphate EP/Cl...
2022-06-17
Application Number
21309
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
CLOPIDOGREL BISULFATE USP (FORM-1) ...
Clopidogrel hydrogen sulfate, Form ...
Clopidogrel Hydrogen Sulphate EP/Cl...
Issue/Submission Date
2008-02-04
2022-01-26
2022-06-17
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USDMF

Found USDMF

31088
Active
CYCLOPHOSPHAMIDE MONOHYDRATE USP
2016-12-01
CEP/COS

Found CEP/COS

R0-CEP 2018-092 - Rev 01
Valid
Cyclophosphamide monohydrate
2023-08-23
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Cyclophosphamide Monohydrate USP/EP
2022-09-02
Application Number
31088
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
CYCLOPHOSPHAMIDE MONOHYDRATE USP
Cyclophosphamide monohydrate
Cyclophosphamide Monohydrate USP/EP
Issue/Submission Date
2016-12-01
2023-08-23
2022-09-02
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USDMF

Found USDMF

25837
Active
DEFERASIROX [ROUTE CODE - "DR"]
2012-02-21
CEP/COS

Found CEP/COS

R0-CEP 2021-037 - Rev 00
Valid
Deferasirox
2023-03-10
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Deferasirox IH
2022-06-17
Application Number
25837
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DEFERASIROX [ROUTE CODE - "DR"]
Deferasirox
Deferasirox IH
Issue/Submission Date
2012-02-21
2023-03-10
2022-06-17
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USDMF

Found USDMF

27308
Active
DOCETAXEL ANHYDROUS USP [ROUTE CODE...
2013-07-31
CEP/COS

Found CEP/COS

R1-CEP 2016-014 - Rev 00
Valid
Docetaxel trihydrate
2022-09-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Docetaxel Anhydrous (USP)
2022-09-02
Application Number
27308
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
DOCETAXEL ANHYDROUS USP [ROUTE CODE...
Docetaxel trihydrate
Docetaxel Anhydrous (USP)
Issue/Submission Date
2013-07-31
2022-09-06
2022-09-02
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USDMF

Found USDMF

26956
Active
DRONEDARONE HYDROCHLORIDE USP [ROUT...
2013-03-29
CEP/COS

Found CEP/COS

R0-CEP 2020-033 - Rev 00
Valid
Dronedarone hydrochloride
2022-08-09
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Dronedarone Hydrochloride IH
2022-06-17
Application Number
26956
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DRONEDARONE HYDROCHLORIDE USP [ROUT...
Dronedarone hydrochloride
Dronedarone Hydrochloride IH
Issue/Submission Date
2013-03-29
2022-08-09
2022-06-17
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USDMF

Found USDMF

23466
Active
EPLERENONE [ROUTE CODE: PL]
2010-01-20
CEP/COS

Found CEP/COS

R1-CEP 2015-312 - Rev 02
Valid
Eplerenone
2022-10-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
EplerenoneIH
2022-06-17
Application Number
23466
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
EPLERENONE [ROUTE CODE: PL]
Eplerenone
EplerenoneIH
Issue/Submission Date
2010-01-20
2022-10-06
2022-06-17
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USDMF

Found USDMF

21554
Active
EZETIMIBE USP [ROUTE CODE - EB]
2008-04-17
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

230MF10090
Ezetimibe at Plot No: C-24, Sanath ...
2018-07-26
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Ezetimibe IH
2022-06-17
Application Number
21554
230MF10090
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-14
Filing Details
EZETIMIBE USP [ROUTE CODE - EB]
Ezetimibe at Plot No: C-24, Sanath ...
Ezetimibe IH
Issue/Submission Date
2008-04-17
2018-07-26
2022-06-17
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USDMF

Found USDMF

21276
Active
FINASTERIDE USP
2008-01-21
CEP/COS

Found CEP/COS

R1-CEP 2008-024 - Rev 04
Valid
Finasteride
2019-08-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
FinasterideUSP/EP
2022-06-17
Application Number
21276
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
FINASTERIDE USP
Finasteride
FinasterideUSP/EP
Issue/Submission Date
2008-01-21
2019-08-06
2022-06-17
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USDMF

Found USDMF

27830
Active
FINGOLIMOD HYDROCHLORIDE USP [ROUTE...
2013-12-30
CEP/COS

Found CEP/COS

R0-CEP 2019-290 - Rev 01
Valid
Fingolimod hydrochloride
2023-08-11
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Fingolimod Hydrochloride (IHS)
2022-09-02
Application Number
27830
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
FINGOLIMOD HYDROCHLORIDE USP [ROUTE...
Fingolimod hydrochloride
Fingolimod Hydrochloride (IHS)
Issue/Submission Date
2013-12-30
2023-08-11
2022-09-02
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USDMF

Found USDMF

28011
Active
FORMOTEROL FUMARATE USP [ROUTE CODE...
2014-03-03
CEP/COS

Found CEP/COS

R1-CEP 2016-011 - Rev 00
Valid
Formoterol fumarate dihydrate
2022-09-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Formoterol Fumarate Dihydrate EP/Fo...
2022-06-17
Application Number
28011
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
FORMOTEROL FUMARATE USP [ROUTE CODE...
Formoterol fumarate dihydrate
Formoterol Fumarate Dihydrate EP/Fo...
Issue/Submission Date
2014-03-03
2022-09-12
2022-06-17
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USDMF

Found USDMF

29670
Active
GEFITINIB [ROUTE CODE GN]
2015-09-04
CEP/COS

Found CEP/COS

CEP 2016-227 - Rev 02
Valid
Gefitinib
2024-01-23
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Gefitinib (IHS)
2022-09-02
Application Number
29670
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
GEFITINIB [ROUTE CODE GN]
Gefitinib
Gefitinib (IHS)
Issue/Submission Date
2015-09-04
2024-01-23
2022-09-02
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USDMF

Found USDMF

26386
Active
IMATINIB MESYLATE [ROUTE CODE-" IT"...
2012-11-06
CEP/COS

Found CEP/COS

CEP 2017-118 - Rev 01
Valid
Imatinib mesilate
2024-03-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Imatinib Mesylate (IHS)
2022-09-02
Application Number
26386
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
IMATINIB MESYLATE [ROUTE CODE-" IT"...
Imatinib mesilate
Imatinib Mesylate (IHS)
Issue/Submission Date
2012-11-06
2024-03-15
2022-09-02
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USDMF

Found USDMF

21693
Active
KETOROLAC TROMETHAMINE USP
2008-05-28
CEP/COS

Found CEP/COS

R1-CEP 2008-144 - Rev 03
Valid
Ketorolac trometamol
2019-06-24
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Ketorolac Trometamol EP/Ketorolac T...
2022-06-17
Application Number
21693
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
KETOROLAC TROMETHAMINE USP
Ketorolac trometamol
Ketorolac Trometamol EP/Ketorolac T...
Issue/Submission Date
2008-05-28
2019-06-24
2022-06-17
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USDMF

Found USDMF

29197
Active
NEOSTIGMINE METHYLSULFATE USP [ROUT...
2015-03-31
CEP/COS

Found CEP/COS

R1-CEP 2016-044 - Rev 00
Valid
Neostigmine metilsulfate
2022-09-09
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Neostigmine Methylsulfate USP/EP
2022-06-17
Application Number
29197
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
NEOSTIGMINE METHYLSULFATE USP [ROUT...
Neostigmine metilsulfate
Neostigmine Methylsulfate USP/EP
Issue/Submission Date
2015-03-31
2022-09-09
2022-06-17
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USDMF

Found USDMF

32661
Active
NILOTINIB HYDROCHLORIDE (MONOHYDRAT...
2018-03-30
CEP/COS

Found CEP/COS

R0-CEP 2020-176 - Rev 00
Valid
Nilotinib hydrochloride monohydrate
2022-12-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Nilotinib HCl IH
2022-09-02
Application Number
32661
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
NILOTINIB HYDROCHLORIDE (MONOHYDRAT...
Nilotinib hydrochloride monohydrate
Nilotinib HCl IH
Issue/Submission Date
2018-03-30
2022-12-06
2022-09-02
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USDMF

Found USDMF

23690
Active
OLMESARTAN MEDOXOMIL USP [ROUTE COD...
2010-04-07
CEP/COS

Found CEP/COS

R1-CEP 2012-070 - Rev 01
Valid
Olmesartan medoxomil
2019-12-05
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Olmesartan Medoxomil EP
2022-06-17
Application Number
23690
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
OLMESARTAN MEDOXOMIL USP [ROUTE COD...
Olmesartan medoxomil
Olmesartan Medoxomil EP
Issue/Submission Date
2010-04-07
2019-12-05
2022-06-17
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USDMF

Found USDMF

24624
Active
OLOPATADINE HYDROCHLORIDE USP [ROUT...
2011-02-08
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

224MF10094
Olopatadine hydrochloride at Plot N...
2012-04-27
Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Olopatadine Hydrochloride IH/USP
2022-06-17
Application Number
24624
224MF10094
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-14
Filing Details
OLOPATADINE HYDROCHLORIDE USP [ROUT...
Olopatadine hydrochloride at Plot N...
Olopatadine Hydrochloride IH/USP
Issue/Submission Date
2011-02-08
2012-04-27
2022-06-17
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USDMF

Found USDMF

32194
Active
PACLITAXEL USP
2017-10-31
CEP/COS

Found CEP/COS

R0-CEP 2020-038 - Rev 01
Valid
Paclitaxel, Produced by a semi-synt...
2023-01-26
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Paclitaxel USP/EP
2022-09-02
Application Number
32194
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
PACLITAXEL USP
Paclitaxel, Produced by a semi-synt...
Paclitaxel USP/EP
Issue/Submission Date
2017-10-31
2023-01-26
2022-09-02
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USDMF

Found USDMF

20850
Active
PANTOPRAZOLE SODIUM USP [ROUTE CODE...
2007-09-10
CEP/COS

Found CEP/COS

R1-CEP 2010-060 - Rev 02
Valid
Pantoprazole sodium sesquihydrate
2023-01-18
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Pantoprazole Sodium/Pantoprazole So...
2022-06-17
Application Number
20850
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
PANTOPRAZOLE SODIUM USP [ROUTE CODE...
Pantoprazole sodium sesquihydrate
Pantoprazole Sodium/Pantoprazole So...
Issue/Submission Date
2007-09-10
2023-01-18
2022-06-17
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USDMF

Found USDMF

28094
Active
PEMETREXED DISODIUM HEPTAHYDRATE US...
2014-03-26
CEP/COS

Found CEP/COS

R0-CEP 2020-336 - Rev 01
Valid
Pemetrexed disodium heptahydrate
2023-08-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Pemetrexed Disodium Hemipentahydrat...
2022-09-02
Application Number
28094
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-05-05
Filing Details
PEMETREXED DISODIUM HEPTAHYDRATE US...
Pemetrexed disodium heptahydrate
Pemetrexed Disodium Hemipentahydrat...
Issue/Submission Date
2014-03-26
2023-08-16
2022-09-02
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USDMF

Found USDMF

23900
Active
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
2010-06-22
CEP/COS

Found CEP/COS

R1-CEP 2011-050 - Rev 01
Valid
Pramipexole dihydrochloride monohyd...
2020-08-18
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Pramipexole Dihydrochloride USP/Pra...
2022-06-17
Application Number
23900
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Pramipexole dihydrochloride monohyd...
Pramipexole Dihydrochloride USP/Pra...
Issue/Submission Date
2010-06-22
2020-08-18
2022-06-17
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USDMF

Found USDMF

26958
Active
PRASUGREL HYDROCHLORIDE USP [ROUTE ...
2013-03-30
CEP/COS

Found CEP/COS

R0-CEP 2021-024 - Rev 00
Valid
Prasugrel hydrochloride
2023-03-29
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Prasugrel Hydrochloride IH
2022-06-17
Application Number
26958
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
PRASUGREL HYDROCHLORIDE USP [ROUTE ...
Prasugrel hydrochloride
Prasugrel Hydrochloride IH
Issue/Submission Date
2013-03-30
2023-03-29
2022-06-17
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USDMF

Found USDMF

27807
Active
RIVAROXABAN USP [ROUTE CODE "RR")
2013-12-31
CEP/COS

Found CEP/COS

R0-CEP 2021-028 - Rev 00
Valid
Rivaroxaban
2023-02-24
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Rivaroxaban IH
2022-06-17
Application Number
27807
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
RIVAROXABAN USP [ROUTE CODE "RR")
Rivaroxaban
Rivaroxaban IH
Issue/Submission Date
2013-12-31
2023-02-24
2022-06-17
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USDMF

Found USDMF

20712
Active
ROSUVASTATIN CALCIUM USP [ROUTE COD...
2007-07-25
CEP/COS

Found CEP/COS

CEP 2020-057 - Rev 01
Valid
Rosuvastatin calcium
2024-03-20
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Rosuvastatin Calcium USP/EP/Rosuvas...
2022-06-17
Application Number
20712
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
ROSUVASTATIN CALCIUM USP [ROUTE COD...
Rosuvastatin calcium
Rosuvastatin Calcium USP/EP/Rosuvas...
Issue/Submission Date
2007-07-25
2024-03-20
2022-06-17
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USDMF

Found USDMF

24828
Active
SALMETEROL XINAFOATE USP [ROUTE COD...
2011-04-05
CEP/COS

Found CEP/COS

R1-CEP 2011-183 - Rev 00
Valid
Salmeterol xinafoate
2018-03-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Salmeterol Xinafoate EP
2022-06-17
Application Number
24828
Indian CDSCO WC-0021n
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-14
Filing Details
SALMETEROL XINAFOATE USP [ROUTE COD...
Salmeterol xinafoate
Salmeterol Xinafoate EP
Issue/Submission Date
2011-04-05
2018-03-12
2022-06-17
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USDMF

Found USDMF

23747
Active
SOLIFENACIN SUCCINATE [ROUTE CODE -...
2010-04-26
CEP/COS

Found CEP/COS

R1-CEP 2016-201 - Rev 00
Valid
Solifenacin succinate
2022-08-25
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Solifenacin Succinate IH
2022-06-17
Application Number
23747
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
SOLIFENACIN SUCCINATE [ROUTE CODE -...
Solifenacin succinate
Solifenacin Succinate IH
Issue/Submission Date
2010-04-26
2022-08-25
2022-06-17
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USDMF

Found USDMF

30180
Active
SORAFENIB TOSYLATE (FORM-III) [ROUT...
2016-01-30
CEP/COS

Found CEP/COS

CEP 2021-430 - Rev 01
Valid
Sorafenib tosilate, Form-III
2023-09-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Sorafenib Tosylate IHS
2022-09-02
Application Number
30180
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
SORAFENIB TOSYLATE (FORM-III) [ROUT...
Sorafenib tosilate, Form-III
Sorafenib Tosylate IHS
Issue/Submission Date
2016-01-30
2023-09-15
2022-09-02
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USDMF

Found USDMF

20413
Active
TERBINAFINE HYDROCHLORIDE USP [ROUT...
2007-04-05
CEP/COS

Found CEP/COS

R1-CEP 2006-157 - Rev 04
Valid
Terbinafine hydrochloride
2019-08-01
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Terbinafine Hydrochloride USP/EP
2022-06-17
Application Number
20413
Indian CDSCO WC-0021n
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-14
Filing Details
TERBINAFINE HYDROCHLORIDE USP [ROUT...
Terbinafine hydrochloride
Terbinafine Hydrochloride USP/EP
Issue/Submission Date
2007-04-05
2019-08-01
2022-06-17
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USDMF

Found USDMF

27860
Active
TERIFLUNOMIDE [ROUTE CODE "TO"]
2014-01-29
CEP/COS

Found CEP/COS

CEP 2020-403 - Rev 01
Valid
Teriflunomide, Form-M
2024-02-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Teriflunomide IH
2022-06-17
Application Number
27860
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
TERIFLUNOMIDE [ROUTE CODE "TO"]
Teriflunomide, Form-M
Teriflunomide IH
Issue/Submission Date
2014-01-29
2024-02-15
2022-06-17
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USDMF

Found USDMF

33573
Active
TRIFLURIDINE USP
2019-02-16
CEP/COS

Found CEP/COS

R0-CEP 2021-202 - Rev 01
Valid
Trifluridine
2023-08-10
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0349
Valid
Trifluridine USP
2022-09-02
Application Number
33573
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
TRIFLURIDINE USP
Trifluridine
Trifluridine USP
Issue/Submission Date
2019-02-16
2023-08-10
2022-09-02
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USDMF

Found USDMF

25881
Active
TROSPIUM CHLORIDE USP [ROUTE CODE -...
2012-03-03
CEP/COS

Found CEP/COS

R1-CEP 2012-119 - Rev 00
Valid
Trospium chloride
2018-11-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Trospium Chloride EP
2022-06-17
Application Number
25881
Indian CDSCO WC-0021n
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-14
Filing Details
TROSPIUM CHLORIDE USP [ROUTE CODE -...
Trospium chloride
Trospium Chloride EP
Issue/Submission Date
2012-03-03
2018-11-12
2022-06-17
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USDMF

Found USDMF

27240
Active
VIGABATRIN USP [ROUTE CODE - "VB"]
2013-06-29
CEP/COS

Found CEP/COS

R1-CEP 2015-344 - Rev 00
Valid
Vigabatrin
2021-11-02
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0021n
Valid
Vigabatrin EP/USP
2022-06-17
Application Number
27240
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
VIGABATRIN USP [ROUTE CODE - "VB"]
Vigabatrin
Vigabatrin EP/USP
Issue/Submission Date
2013-06-29
2021-11-02
2022-06-17
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USDMF

Found USDMF

20580
Active
MONTELUKAST SODIUM USP [ROUTE CODE ...
2007-06-07
CEP/COS

Found CEP/COS

R1-CEP 2012-091 - Rev 00
Valid
Montelukast sodium
2019-09-13
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0022
Expired
Montelukast Sodium (Ph. Eur)
2019-08-16
Application Number
20580
Indian CDSCO WC-0022
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
MONTELUKAST SODIUM USP [ROUTE CODE ...
Montelukast sodium
Montelukast Sodium (Ph. Eur)
Issue/Submission Date
2007-06-07
2019-09-13
2019-08-16
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USDMF

Found USDMF

20755
Active
MOXIFLOXACIN HYDROCHLORIDE USP (MON...
2007-08-03
CEP/COS

Found CEP/COS

CEP 2015-360 - Rev 01
Valid
Moxifloxacin hydrochloride, Route c...
2023-09-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0022
Expired
Moxifloxacin Hydrochloride (1H)
2019-08-16
Application Number
20755
Indian CDSCO WC-0022
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
MOXIFLOXACIN HYDROCHLORIDE USP (MON...
Moxifloxacin hydrochloride, Route c...
Moxifloxacin Hydrochloride (1H)
Issue/Submission Date
2007-08-03
2023-09-07
2019-08-16
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