CSBio CSBio

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dr. Reddy's Laboratories

  • Webinars & Exhibitions

  • Abiraterone Acetate

  • Abiraterone Decanoate

  • Apixaban

  • Atorvastatin

  • Bempedoic Acid

  • Capecitabine

  • Cetirizine

  • Cetirizine Dihydrochloride

  • Clopidogrel

  • Clopidogrel Besylate

  • Clopidogrel Hydrochloride

  • Dapagliflozin

  • Dapagliflozin Propanediol Monohydrate

  • Eribulin

  • Famotidine

  • Gemcitabine

  • Levetiracetam

  • Losartan Potassium

  • Palbociclib

  • Rabeprazole

  • Ranolazine

  • Sacubitril-Valsartan

  • Sitagliptin Hydrochloride

  • Sitagliptin Malate

  • Sitagliptin Phosphate

  • Valsartan

PharmaCompass
DRL
Dr. Reddy\
india-flag Flag
Country
Country
India
Address
Address
8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telangana-500 034
Telephone
Telephone
+91 4049002900
Contact Info
Others

ListList of Products
See all info for this product

See Less

USDMF

Found USDMF

16473
Active
AMLODIPINE BESILATE USP
2003-03-19
CEP/COS

Found CEP/COS

R1-CEP 2003-007 - Rev 06
Valid
Amlodipine besilate
2017-08-23
Japanese DMF

Found JDMF

219MF10352
Amlodipine besylate at 8-2-337, Roa...
2007-12-10
Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Amlodipine maleate IH/Amlodipine Be...
2022-06-06
Application Number
16473
219MF10352
Indian CDSCO WC-0035a
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
AMLODIPINE BESILATE USP
Amlodipine besilate
Amlodipine besylate at 8-2-337, Roa...
Amlodipine maleate IH/Amlodipine Be...
Issue/Submission Date
2003-03-19
2017-08-23
2007-12-10
2022-06-06
See all info for this product

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USDMF

Found USDMF

18468
Active
ATORVASTATIN CALCIUM (AMORPHOUS)
2005-06-29
CEP/COS

Found CEP/COS

R0-CEP 2020-092 - Rev 02
Valid
Atorvastatin calcium, Form I, ATN p...
2023-06-02
Japanese DMF

Found JDMF

304MF10140
ATORVA STATN CALCIUM HYDRATE at 8-2...
2022-10-05
Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Atorvastatin Calcium Trihydrate (IH...
2022-06-15
Application Number
18468
304MF10140
Indian CDSCO WC-0034
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ATORVASTATIN CALCIUM (AMORPHOUS)
Atorvastatin calcium, Form I, ATN p...
ATORVA STATN CALCIUM HYDRATE at 8-2...
Atorvastatin Calcium Trihydrate (IH...
Issue/Submission Date
2005-06-29
2023-06-02
2022-10-05
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

22479
Active
CAPECITABINE USP
2009-01-30
CEP/COS

Found CEP/COS

R1-CEP 2014-203 - Rev 00
Valid
Capecitabine
2020-05-07
Japanese DMF

Found JDMF

304MF10153
Capecitabine at 8-2-337, Road No. 3...
2022-12-07
Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Capecitabine EP
2022-07-04
Application Number
22479
304MF10153
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine at 8-2-337, Road No. 3...
Capecitabine EP
Issue/Submission Date
2009-01-30
2020-05-07
2022-12-07
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

18395
Active
CETIRIZINE DIHYDROCHLORIDE
2005-05-27
CEP/COS

Found CEP/COS

R1-CEP 2009-206 - Rev 03
Valid
Cetirizine dihydrochloride, Process...
2020-01-08
Japanese DMF

Found JDMF

218MF10306
CETIRIZINE DIHYDROCHLORIDE EP at 8-...
2006-04-20
Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Cetirizine Di Hydrochloride (Ph. Eu...
2022-06-06
Application Number
18395
218MF10306
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
CETIRIZINE DIHYDROCHLORIDE
Cetirizine dihydrochloride, Process...
CETIRIZINE DIHYDROCHLORIDE EP at 8-...
Cetirizine Di Hydrochloride (Ph. Eu...
Issue/Submission Date
2005-05-27
2020-01-08
2006-04-20
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

16090
Active
CLOPIDOGREL BISULFATE [FORM-I] USP
2002-08-07
CEP/COS

Found CEP/COS

R1-CEP 2012-059 - Rev 02
Valid
Clopidogrel hydrogen sulfate, Form-...
2022-09-27
Japanese DMF

Found JDMF

304MF10059
CLOPIDOGREL SULFATE FORM-I at 8-2-3...
2022-03-30
Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Clopidogrel Hydrogen Sulfate (Ph. E...
2022-06-06
Application Number
16090
304MF10059
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
CLOPIDOGREL BISULFATE [FORM-I] USP
Clopidogrel hydrogen sulfate, Form-...
CLOPIDOGREL SULFATE FORM-I at 8-2-3...
Clopidogrel Hydrogen Sulfate (Ph. E...
Issue/Submission Date
2002-08-07
2022-09-27
2022-03-30
2022-06-06
See all info for this product

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USDMF

Found USDMF

35506
Active
CLOPIDOGREL BISULFATE FORM-II
2020-12-30
CEP/COS

Found CEP/COS

R0-CEP 2021-052 - Rev 01
Valid
Clopidogrel hydrogen sulfate, Form ...
2023-02-20
Japanese DMF

Found JDMF

303MF10053
CLOPIDOGREL SULPHATE FORM-II at 8-2...
2021-03-26
Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Clopidogrel Hydrogen Sulphate EP/Cl...
2022-06-08
Application Number
35506
303MF10053
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-04
Filing Details
CLOPIDOGREL BISULFATE FORM-II
Clopidogrel hydrogen sulfate, Form ...
CLOPIDOGREL SULPHATE FORM-II at 8-2...
Clopidogrel Hydrogen Sulphate EP/Cl...
Issue/Submission Date
2020-12-30
2023-02-20
2021-03-26
2022-06-08
See all info for this product

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USDMF

Found USDMF

15757
Active
FEXOFENADINE HYDROCHLORIDE
2001-12-05
CEP/COS

Found CEP/COS

R0-CEP 2021-067 - Rev 00
Valid
Fexofenadine hydrochloride, Form-I
2023-07-06
Japanese DMF

Found JDMF

302MF10124
Fexofenadine Hydrochloride at 8-2-3...
2020-10-05
Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Fexofenadine Hydrochloride USP/EP
2022-06-08
Application Number
15757
302MF10124
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-04
Filing Details
FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochloride, Form-I
Fexofenadine Hydrochloride at 8-2-3...
Fexofenadine Hydrochloride USP/EP
Issue/Submission Date
2001-12-05
2023-07-06
2020-10-05
2022-06-08
See all info for this product

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USDMF

Found USDMF

16010
Active
FINASTERIDE USP (FORM III)
2002-06-11
CEP/COS

Found CEP/COS

R1-CEP 2009-195 - Rev 03
Valid
Finasteride, Form III
2023-07-12
Japanese DMF

Found JDMF

226MF10054
FINASTERIDE Form-Ⅲ at 8-2-337, Ro...
2014-03-06
Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Finasteride (USP/Ph.Eur)
2022-06-15
Application Number
16010
226MF10054
Indian CDSCO WC-0034
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
FINASTERIDE USP (FORM III)
Finasteride, Form III
FINASTERIDE Form-Ⅲ at 8-2-337, Ro...
Finasteride (USP/Ph.Eur)
Issue/Submission Date
2002-06-11
2023-07-12
2014-03-06
2022-06-15
See all info for this product

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USDMF

Found USDMF

18857
Active
GEMCITABINE HYDROCHLORIDE USP
2005-10-11
CEP/COS

Found CEP/COS

R1-CEP 2007-075 - Rev 06
Valid
Gemcitabine hydrochloride
2021-06-18
Japanese DMF

Found JDMF

220MF10243
GEMCITABINE HYDROCHLORIDE at 8-2-33...
2008-12-04
Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Gemcitabine Hydrochloride
2022-06-06
Application Number
18857
220MF10243
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
GEMCITABINE HYDROCHLORIDE at 8-2-33...
Gemcitabine Hydrochloride
Issue/Submission Date
2005-10-11
2021-06-18
2008-12-04
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

16966
Active
LEVETIRACETAM
2003-11-17
CEP/COS

Found CEP/COS

R1-CEP 2011-084 - Rev 01
Valid
Levetiracetam
2018-05-16
Japanese DMF

Found JDMF

302MF10034
Levetiracetam at 8-2-337, Road No. ...
2020-03-09
Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Levetiracetamum IH
2022-07-04
Application Number
16966
302MF10034
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
LEVETIRACETAM
Levetiracetam
Levetiracetam at 8-2-337, Road No. ...
Levetiracetamum IH
Issue/Submission Date
2003-11-17
2018-05-16
2020-03-09
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

14036
Active
NIZATIDINE USP
1999-03-16
CEP/COS

Found CEP/COS

R1-CEP 2002-027 - Rev 06
Valid
Nizatidine
2023-04-24
Japanese DMF

Found JDMF

218MF10215
NIZATIDINE at 8-2-337, Road No. 3, ...
2006-02-16
Written Confirmation

Found WC

Indian CDSCO WC-0067n
Valid
Nizatidine USP/Ph. Eur
2022-06-17
Application Number
14036
218MF10215
Indian CDSCO WC-0067n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
NIZATIDINE USP
Nizatidine
NIZATIDINE at 8-2-337, Road No. 3, ...
Nizatidine USP/Ph. Eur
Issue/Submission Date
1999-03-16
2023-04-24
2006-02-16
2022-06-17
See all info for this product

See Less

USDMF

Found USDMF

15436
Active
ONDANSETRON HYDROCHLORIDE DIHYDRATE...
2001-05-15
CEP/COS

Found CEP/COS

R1-CEP 2005-071 - Rev 06
Valid
Ondansetron hydrochloride dihydrate
2023-05-23
Japanese DMF

Found JDMF

302MF10019
Ondansetron hydrochloride hydrate a...
2020-01-31
Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Ondansetron Hydrochloride USP/Ondan...
2022-06-08
Application Number
15436
302MF10019
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-04
Filing Details
ONDANSETRON HYDROCHLORIDE DIHYDRATE...
Ondansetron hydrochloride dihydrate
Ondansetron hydrochloride hydrate a...
Ondansetron Hydrochloride USP/Ondan...
Issue/Submission Date
2001-05-15
2023-05-23
2020-01-31
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

21295
Active
PIOGLITAZONE HYDROCHLORIDE USP
2008-01-31
CEP/COS

Found CEP/COS

R1-CEP 2013-077 - Rev 00
Valid
Pioglitazone hydrochloride
2019-11-28
Japanese DMF

Found JDMF

303MF10161
Pioglitazone Hydrochloride at 8-2-3...
2021-10-27
Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Pioglitazone Hydrochloride IH
2022-07-04
Application Number
21295
303MF10161
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
PIOGLITAZONE HYDROCHLORIDE USP
Pioglitazone hydrochloride
Pioglitazone Hydrochloride at 8-2-3...
Pioglitazone Hydrochloride IH
Issue/Submission Date
2008-01-31
2019-11-28
2021-10-27
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

16747
Active
RABEPRAZOLE SODIUM HYDRATE (FORM Y)...
2003-08-04
CEP/COS

Found CEP/COS

R0-CEP 2018-189 - Rev 00
Valid
Rabeprazole sodium hydrate, Form-Y ...
2019-05-17
Japanese DMF

Found JDMF

303MF10057
Rabeprazole Sodium at 8-2-337, Road...
2021-04-02
Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Rabeprazole Sodium hydrate EP
2022-06-06
Application Number
16747
303MF10057
Indian CDSCO WC-0035a
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-25
Filing Details
RABEPRAZOLE SODIUM HYDRATE (FORM Y)...
Rabeprazole sodium hydrate, Form-Y ...
Rabeprazole Sodium at 8-2-337, Road...
Rabeprazole Sodium hydrate EP
Issue/Submission Date
2003-08-04
2019-05-17
2021-04-02
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

16902
Active
RISPERIDONE FORM-1 USP
2003-10-10
CEP/COS

Found CEP/COS

R1-CEP 2009-243 - Rev 03
Valid
Risperidone, Form 1
2023-07-17
Japanese DMF

Found JDMF

218MF10413
RISPERIDONE FORM-Ⅰ at 8-2-337, Ro...
2006-04-14
Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Risperidone (Ph. Eur./USP)
2022-06-06
Application Number
16902
218MF10413
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
RISPERIDONE FORM-1 USP
Risperidone, Form 1
RISPERIDONE FORM-Ⅰ at 8-2-337, Ro...
Risperidone (Ph. Eur./USP)
Issue/Submission Date
2003-10-10
2023-07-17
2006-04-14
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

28121
Active
RIVAROXABAN USP
2014-03-31
CEP/COS

Found CEP/COS

R0-CEP 2020-250 - Rev 01
Valid
Rivaroxaban
2022-10-14
Japanese DMF

Found JDMF

304MF10061
Rivaroxaban at 8-2-337, Road No. 3,...
2022-04-06
Written Confirmation

Found WC

Indian CDSCO WC-0067A3-A4
Valid
Rivaroxaban IH
2022-06-13
Application Number
28121
304MF10061
Indian CDSCO WC-0067A3-A4
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
RIVAROXABAN USP
Rivaroxaban
Rivaroxaban at 8-2-337, Road No. 3,...
Rivaroxaban IH
Issue/Submission Date
2014-03-31
2022-10-14
2022-04-06
2022-06-13
See all info for this product

See Less

USDMF

Found USDMF

20319
Active
VALSARTAN
2007-03-02
CEP/COS

Found CEP/COS

R1-CEP 2009-405 - Rev 03
Valid
Valsartan
2021-08-16
Japanese DMF

Found JDMF

225MF10033
Valsartan at 8-2-337, Road No. 3,Ba...
2013-02-20
Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Valsartan JP
2022-07-04
Application Number
20319
225MF10033
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
VALSARTAN
Valsartan
Valsartan at 8-2-337, Road No. 3,Ba...
Valsartan JP
Issue/Submission Date
2007-03-02
2021-08-16
2013-02-20
2022-07-04
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

20100
Active
ALENDRONATE SODIUM
2006-12-29
CEP/COS

Found CEP/COS

R1-CEP 2008-192 - Rev 01
Valid
Sodium alendronate trihydrate
2018-06-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Sodium alendronate EP
2022-06-06
Application Number
20100
Indian CDSCO WC-0035a
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-25
Filing Details
ALENDRONATE SODIUM
Sodium alendronate trihydrate
Sodium alendronate EP
Issue/Submission Date
2006-12-29
2018-06-22
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

19997
Active
ATORVASTATIN CALCIUM (FORM P) USP, ...
2006-11-27
CEP/COS

Found CEP/COS

CEP 2011-222 - Rev 02
Valid
Atorvastatin calcium, Form-I
2023-09-11
Japanese DMF

Found JDMF

228MF10199
Atorvastatin Calcium Hydrate at 8-2...
2016-10-19
Written Confirmation

Close WC

Application Number
19997
228MF10199
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ATORVASTATIN CALCIUM (FORM P) USP, ...
Atorvastatin calcium, Form-I
Atorvastatin Calcium Hydrate at 8-2...
Issue/Submission Date
2006-11-27
2023-09-11
2016-10-19
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

14699
Active
CIPROFLOXACIN USP
2000-02-02
CEP/COS

Found CEP/COS

R1-CEP 2005-133 - Rev 03
Valid
Ciprofloxacin
2018-06-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Ciprofloxacin Hydrchloride (USP/Ph....
2022-06-15
Application Number
14699
Indian CDSCO WC-0034
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
CIPROFLOXACIN USP
Ciprofloxacin
Ciprofloxacin Hydrchloride (USP/Ph....
Issue/Submission Date
2000-02-02
2018-06-22
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

19456
Active
DESLORATADINE USP
2006-05-24
CEP/COS

Found CEP/COS

CEP 2014-321 - Rev 02
Valid
Desloratadine
2024-01-25
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Desloratadine USP/EP
2022-07-04
Application Number
19456
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
DESLORATADINE USP
Desloratadine
Desloratadine USP/EP
Issue/Submission Date
2006-05-24
2024-01-25
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

13836
Active
ENALAPRIL MALEATE, USP
1998-11-09
CEP/COS

Found CEP/COS

R1-CEP 2002-076 - Rev 05
Valid
Enalapril maleate
2018-08-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Enalapril Maleate USP/EP
2022-06-08
Application Number
13836
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-04
Filing Details
ENALAPRIL MALEATE, USP
Enalapril maleate
Enalapril Maleate USP/EP
Issue/Submission Date
1998-11-09
2018-08-28
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

14309
Active
FAMOTIDINE USP
1999-07-22
CEP/COS

Found CEP/COS

R1-CEP 2009-161 - Rev 01
Valid
Famotidine
2023-05-31
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Famotidine USP/EP
2022-06-08
Application Number
14309
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-04
Filing Details
FAMOTIDINE USP
Famotidine
Famotidine USP/EP
Issue/Submission Date
1999-07-22
2023-05-31
2022-06-08
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

13069
Active
FLUOXETINE HYDROCHLORIDE USP
1998-07-09
CEP/COS

Found CEP/COS

R1-CEP 1999-171 - Rev 06
Valid
Fluoxetine hydrochloride
2018-06-25
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
FLUOXETINE HCI EP
2022-06-06
Application Number
13069
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
FLUOXETINE HYDROCHLORIDE USP
Fluoxetine hydrochloride
FLUOXETINE HCI EP
Issue/Submission Date
1998-07-09
2018-06-25
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

16983
Active
GLIMEPIRIDE USP
2003-11-26
CEP/COS

Found CEP/COS

R1-CEP 2008-072 - Rev 05
Valid
Glimepiride
2022-03-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Glimepiride (USP/Ph. Eur.)
2022-06-15
Application Number
16983
Indian CDSCO WC-0034
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
GLIMEPIRIDE USP
Glimepiride
Glimepiride (USP/Ph. Eur.)
Issue/Submission Date
2003-11-26
2022-03-08
2022-06-15
See all info for this product

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USDMF

Found USDMF

20008
Active
IRBESARTAN USP
2006-12-01
CEP/COS

Found CEP/COS

R1-CEP 2010-067 - Rev 01
Valid
Irbesartan
2019-12-11
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Irbesartan IH
2022-07-04
Application Number
20008
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
IRBESARTAN USP
Irbesartan
Irbesartan IH
Issue/Submission Date
2006-12-01
2019-12-11
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

14603
Active
KETOROLAC TROMETHAMINE USP
1999-11-23
CEP/COS

Found CEP/COS

R1-CEP 2008-069 - Rev 05
Valid
Ketorolac trometamol
2023-08-21
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-390A4
Valid
Ketorolac Trometamol EP/Ketorolac T...
2022-09-30
Application Number
14603
Indian CDSCO WC-390A4
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-11-30
Filing Details
KETOROLAC TROMETHAMINE USP
Ketorolac trometamol
Ketorolac Trometamol EP/Ketorolac T...
Issue/Submission Date
1999-11-23
2023-08-21
2022-09-30
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

21426
Active
LANSOPRAZOLE FORM-1
2008-03-17
CEP/COS

Found CEP/COS

R1-CEP 2010-112 - Rev 00
Valid
Lansoprazole, Form I
2016-10-10
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
lansoprazol EP/USP
2022-07-04
Application Number
21426
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
LANSOPRAZOLE FORM-1
Lansoprazole, Form I
lansoprazol EP/USP
Issue/Submission Date
2008-03-17
2016-10-10
2022-07-04
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

21036
Active
LETROZOLE
2007-11-13
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

226MF10041
LETROZOLE at 8-2-337, Road No. 3, B...
2014-02-19
Written Confirmation

Found WC

Indian CDSCO WC-0067A3-A4
Valid
Letrozole EP/USP
2022-06-13
Application Number
21036
226MF10041
Indian CDSCO WC-0067A3-A4
Status
Active
Fees Paid
N/A
 
Valid
2025-07-07
Filing Details
LETROZOLE
LETROZOLE at 8-2-337, Road No. 3, B...
Letrozole EP/USP
Issue/Submission Date
2007-11-13
2014-02-19
2022-06-13
See all info for this product

See Less

USDMF

Found USDMF

20358
Active
LOSARTAN POTASSIUM FORM-1
2007-03-20
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

222MF10263
Losartan potassium at 8-2-337, Road...
2010-11-29
Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Losartan Potassium (Ph. Eur./USP/IH...
2022-06-06
Application Number
20358
222MF10263
Indian CDSCO WC-0039
Status
Active
Fees Paid
N/A
 
Valid
2025-07-07
Filing Details
LOSARTAN POTASSIUM FORM-1
Losartan potassium at 8-2-337, Road...
Losartan Potassium (Ph. Eur./USP/IH...
Issue/Submission Date
2007-03-20
2010-11-29
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

16999
Active
MOXIFLOXACIN HYDROCHLORIDE USP
2003-12-02
CEP/COS

Found CEP/COS

R1-CEP 2013-078 - Rev 00
Valid
Moxifloxacin hydrochloride, Process...
2019-01-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Moxifloxacin Hydrochloride (USP/Ph....
2022-06-15
Application Number
16999
Indian CDSCO WC-0034
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
MOXIFLOXACIN HYDROCHLORIDE USP
Moxifloxacin hydrochloride, Process...
Moxifloxacin Hydrochloride (USP/Ph....
Issue/Submission Date
2003-12-02
2019-01-22
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

2030
Active
NAPROXEN
1972-12-18
CEP/COS

Found CEP/COS

R1-CEP 1997-039 - Rev 07
Valid
Naproxen
2019-06-21
Japanese DMF

Found JDMF

219MF10208
Naproxen at Km. 4.5 Carretera Feder...
2007-06-25
Written Confirmation

Close WC

Application Number
2030
219MF10208
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NAPROXEN
Naproxen
Naproxen at Km. 4.5 Carretera Feder...
Issue/Submission Date
1972-12-18
2019-06-21
2007-06-25
See all info for this product

See Less

USDMF

Found USDMF

17648
Active
NARATRIPTAN HYDROCHLORIDE
2004-08-30
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10063
Naratriptan Hydrochloride at 8-2-33...
2022-04-06
Written Confirmation

Found WC

Indian CDSCO WC-0067A3-A4
Valid
Naratriptan Hydrochloride IH/USP
2022-06-13
Application Number
17648
304MF10063
Indian CDSCO WC-0067A3-A4
Status
Active
Fees Paid
N/A
 
Valid
2025-07-07
Filing Details
NARATRIPTAN HYDROCHLORIDE
Naratriptan Hydrochloride at 8-2-33...
Naratriptan Hydrochloride IH/USP
Issue/Submission Date
2004-08-30
2022-04-06
2022-06-13
See all info for this product

See Less

USDMF

Found USDMF

15299
Active
OLANZAPINE (FORM 1) USP
2001-02-23
CEP/COS

Found CEP/COS

R1-CEP 2011-392 - Rev 02
Valid
Olanzapine, Form-I
2023-05-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-390A4
Valid
Olanzapine USP/EP
2022-09-30
Application Number
15299
Indian CDSCO WC-390A4
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-11-30
Filing Details
OLANZAPINE (FORM 1) USP
Olanzapine, Form-I
Olanzapine USP/EP
Issue/Submission Date
2001-02-23
2023-05-15
2022-09-30
See all info for this product

See Less

USDMF

Found USDMF

12917
Active
OMEPRAZOLE, USP
1998-03-25
CEP/COS

Found CEP/COS

R1-CEP 2001-415 - Rev 07
Valid
Omeprazole
2018-06-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Omeprazole EP
2022-06-06
Application Number
12917
Indian CDSCO WC-0035a
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
OMEPRAZOLE, USP
Omeprazole
Omeprazole EP
Issue/Submission Date
1998-03-25
2018-06-22
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

19713
Active
OMEPRAZOLE (FORM B) USP
2006-08-28
CEP/COS

Found CEP/COS

R1-CEP 2011-228 - Rev 02
Valid
Omeprazole, Process II
2020-08-27
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0043Amended
Valid
Omeprazole USP/EP/BP
2022-06-08
Application Number
19713
Indian CDSCO WC-0043Amended
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-04
Filing Details
OMEPRAZOLE (FORM B) USP
Omeprazole, Process II
Omeprazole USP/EP/BP
Issue/Submission Date
2006-08-28
2020-08-27
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

17706
Active
OMEPRAZOLE MAGNESIUM
2004-09-24
CEP/COS

Found CEP/COS

R0-CEP 2022-115 - Rev 00
Valid
Omeprazole magnesium
2023-08-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Omeprazole Magnesium EP
2022-06-06
Application Number
17706
Indian CDSCO WC-0035a
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-25
Filing Details
OMEPRAZOLE MAGNESIUM
Omeprazole magnesium
Omeprazole Magnesium EP
Issue/Submission Date
2004-09-24
2023-08-17
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

17103
Active
PANTOPRAZOLE SODIUM USP
2004-01-20
CEP/COS

Found CEP/COS

R1-CEP 2010-319 - Rev 01
Valid
Pantoprazole sodium sesquihydrate
2017-03-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Pantoprazole Sodium Sesquihydrate E...
2022-06-06
Application Number
17103
Indian CDSCO WC-0035a
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
PANTOPRAZOLE SODIUM USP
Pantoprazole sodium sesquihydrate
Pantoprazole Sodium Sesquihydrate E...
Issue/Submission Date
2004-01-20
2017-03-28
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

17122
Active
QUETIAPINE FUMARATE USP
2004-01-29
CEP/COS

Found CEP/COS

R1-CEP 2014-200 - Rev 00
Valid
Quetiapine Fumarate
2021-04-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Quetiapine FumarateEP/USP
2022-07-04
Application Number
17122
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
QUETIAPINE FUMARATE USP
Quetiapine Fumarate
Quetiapine FumarateEP/USP
Issue/Submission Date
2004-01-29
2021-04-15
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

16143
Active
RALOXIFENE HYDROCHLORIDE USP
2002-09-23
CEP/COS

Found CEP/COS

R1-CEP 2014-054 - Rev 01
Valid
Raloxifene hydrochloride
2023-03-31
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Raloxifene Hydrochloride (IH/USP/Ph...
2022-06-15
Application Number
16143
Indian CDSCO WC-0034
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
RALOXIFENE HYDROCHLORIDE USP
Raloxifene hydrochloride
Raloxifene Hydrochloride (IH/USP/Ph...
Issue/Submission Date
2002-09-23
2023-03-31
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

16193
Active
RAMIPRIL USP
2002-10-17
CEP/COS

Found CEP/COS

R1-CEP 2003-050 - Rev 09
Valid
Ramipril
2020-12-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Ramipril EP
2022-06-06
Application Number
16193
Indian CDSCO WC-0035a
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
RAMIPRIL USP
Ramipril
Ramipril EP
Issue/Submission Date
2002-10-17
2020-12-08
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

17245
Active
REPAGLINIDE
2004-03-19
CEP/COS

Found CEP/COS

R1-CEP 2008-196 - Rev 03
Valid
Repaglinide
2018-06-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Repaglinide (USP/Ph.Eur)
2022-06-15
Application Number
17245
Indian CDSCO WC-0034
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
REPAGLINIDE
Repaglinide
Repaglinide (USP/Ph.Eur)
Issue/Submission Date
2004-03-19
2018-06-22
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

17249
Active
RIVASTIGMINE HYDROGEN TARTRATE
2004-03-19
CEP/COS

Found CEP/COS

R1-CEP 2013-305 - Rev 00
Valid
Rivastigmine hydrogen tartrate
2020-01-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0039A3
Valid
Rivastigmine Tartrate USP
2022-06-24
Application Number
17249
Indian CDSCO WC-0039A3
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
RIVASTIGMINE HYDROGEN TARTRATE
Rivastigmine hydrogen tartrate
Rivastigmine Tartrate USP
Issue/Submission Date
2004-03-19
2020-01-13
2022-06-24
See all info for this product

See Less

USDMF

Found USDMF

21781
Active
RIVASTIGMINE HYDROGEN TARTRATE (PRO...
2008-07-08
CEP/COS

Found CEP/COS

R0-CEP 2021-248 - Rev 00
Valid
Rivastigmine hydrogen tartrate, Pro...
2021-12-09
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0039
Valid
Rivastigmine Tartrate (USP)/Rivasti...
2022-06-06
Application Number
21781
Indian CDSCO WC-0039
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
RIVASTIGMINE HYDROGEN TARTRATE (PRO...
Rivastigmine hydrogen tartrate, Pro...
Rivastigmine Tartrate (USP)/Rivasti...
Issue/Submission Date
2008-07-08
2021-12-09
2022-06-06
URL Supplier Web Content
NA Not Available For Sales
See all info for this product

See Less

USDMF

Found USDMF

19179
Active
RIZATRIPTAN BENZOATE USP
2006-02-14
CEP/COS

Found CEP/COS

R1-CEP 2012-225 - Rev 00
Valid
Rizatriptan benzoate
2020-05-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0034
Valid
Rizatriptan Benzoate (USP/Ph.Eur)
2022-06-15
Application Number
19179
Indian CDSCO WC-0034
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan benzoate
Rizatriptan Benzoate (USP/Ph.Eur)
Issue/Submission Date
2006-02-14
2020-05-07
2022-06-15
See all info for this product

See Less

USDMF

Found USDMF

15887
Active
TERBINAFINE HYDROCHLORIDE USP
2002-03-06
CEP/COS

Found CEP/COS

R1-CEP 2009-008 - Rev 02
Valid
Terbinafine hydrochloride
2018-01-19
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Terbinafine HCl EP
2022-06-06
Application Number
15887
Indian CDSCO WC-0035a
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-25
Filing Details
TERBINAFINE HYDROCHLORIDE USP
Terbinafine hydrochloride
Terbinafine HCl EP
Issue/Submission Date
2002-03-06
2018-01-19
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

15699
Active
TIZANIDINE HYDROCHLORIDE USP
2001-11-02
CEP/COS

Found CEP/COS

R0-CEP 2020-281 - Rev 00
Valid
Tizanidine hydrochloride
2023-07-05
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035a
Valid
Tizanidine HCl EP
2022-06-06
Application Number
15699
Indian CDSCO WC-0035a
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
TIZANIDINE HYDROCHLORIDE USP
Tizanidine hydrochloride
Tizanidine HCl EP
Issue/Submission Date
2001-11-02
2023-07-05
2022-06-06
See all info for this product

See Less

USDMF

Found USDMF

19996
Active
VORICONAZOLE USP
2006-11-27
CEP/COS

Found CEP/COS

R1-CEP 2012-081 - Rev 00
Valid
Voriconazole
2019-01-03
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0067A4-5
Valid
Voriconazole IH
2022-07-04
Application Number
19996
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
VORICONAZOLE USP
Voriconazole
Voriconazole IH
Issue/Submission Date
2006-11-27
2019-01-03
2022-07-04
See all info for this product

See Less

USDMF

Found USDMF

17922
Active
ZIPRASIDONE HYDROCHLORIDE USP
2004-12-23
CEP/COS

Found CEP/COS

R1-CEP 2013-217 - Rev 02
Valid
Ziprasidone hydrochloride monohydra...
2022-11-29
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-390A4
Valid
Ziprasidone Hydrochloride USP
2022-09-30
Application Number
17922
Indian CDSCO WC-390A4
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-11-30
Filing Details
ZIPRASIDONE HYDROCHLORIDE USP
Ziprasidone hydrochloride monohydra...
Ziprasidone Hydrochloride USP
Issue/Submission Date
2004-12-23
2022-11-29
2022-09-30
See all info for this product

See Less

USDMF

Found USDMF

21344
Active
ZOLEDRONIC ACID MONOHYDRATE USP
2008-02-18
CEP/COS

Found CEP/COS

R0-CEP 2019-314 - Rev 00
Valid
Zoledronic acid monohydrate
2022-07-19
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0035A3
Valid
Zoledronic Acid IH
2022-06-15
Application Number
21344
Indian CDSCO WC-0035A3
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-25
Filing Details
ZOLEDRONIC ACID MONOHYDRATE USP
Zoledronic acid monohydrate
Zoledronic Acid IH
Issue/Submission Date
2008-02-18
2022-07-19
2022-06-15
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