Athena Athena

X

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

  • Webinars & Exhibitions

  • Difelikefalin

  • Empagliflozin

  • Fezolinetant

  • Mirabegron

  • Paliperidone

  • Paliperidone Palmitate

  • Tapinarof

  • Tirzepatide

  • Vilanterol Trifenatate

PharmaCompass
Neuland VB RM
Neuland Laboratories
india-flag Flag
Country
Country
India
Address
Address
11th Floor (5th Level), Phoenix IVY Building, Plot No. 573A-III, Road No. 82, Jubilee Hills, Hyderabad, 500033, Telangana
Telephone
Telephone
+91 4067611600
Contact Info
Others

See all info for this product

See Less

USDMF

Found USDMF

18465
Active
CIPROFLOXACIN USP
2005-06-24
CEP/COS

Found CEP/COS

CEP 2011-389 - Rev 03
Valid
Ciprofloxacin
2023-11-28
Japanese DMF

Found JDMF

219MF10357
Ciprofloxacin at 11th Floor (5th Of...
2007-12-13
Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ciprofloxacin (USP/Ph.Eur)
2022-07-28
Application Number
18465
219MF10357
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
CIPROFLOXACIN USP
Ciprofloxacin
Ciprofloxacin at 11th Floor (5th Of...
Ciprofloxacin (USP/Ph.Eur)
Issue/Submission Date
2005-06-24
2023-11-28
2007-12-13
2022-07-28
See all info for this product

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USDMF

Found USDMF

15434
Active
ENALAPRIL MALEATE
2001-05-15
CEP/COS

Found CEP/COS

R1-CEP 2003-078 - Rev 14
Valid
Enalapril maleate
2023-06-07
Japanese DMF

Found JDMF

219MF10252
Enalapril maleate (production only)...
2007-07-26
Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Enalapril Maleate (USP/Ph.Eur)
2022-07-28
Application Number
15434
219MF10252
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
ENALAPRIL MALEATE
Enalapril maleate
Enalapril maleate (production only)...
Enalapril Maleate (USP/Ph.Eur)
Issue/Submission Date
2001-05-15
2023-06-07
2007-07-26
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

17799
Active
LEVETIRACETAM USP
2004-11-02
CEP/COS

Found CEP/COS

R1-CEP 2011-380 - Rev 06
Valid
Levetiracetam
2023-06-29
Japanese DMF

Found JDMF

302MF10084
Levetiracetam at 11th Floor (5th Of...
2020-07-16
Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Levetiracetam (USP/Ph.Eur)
2022-07-28
Application Number
17799
302MF10084
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
LEVETIRACETAM USP
Levetiracetam
Levetiracetam at 11th Floor (5th Of...
Levetiracetam (USP/Ph.Eur)
Issue/Submission Date
2004-11-02
2023-06-29
2020-07-16
2022-07-28
See all info for this product

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USDMF

Found USDMF

16007
Active
MIRTAZAPINE
2002-06-11
CEP/COS

Found CEP/COS

R1-CEP 2008-243 - Rev 05
Valid
Mirtazapine
2022-12-19
Japanese DMF

Found JDMF

301MF10005
Mirtazapine at 11th Floor (5th Offi...
2019-05-15
Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Mirtazapine (USP/Ph.Eur)
2022-07-28
Application Number
16007
301MF10005
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
MIRTAZAPINE
Mirtazapine
Mirtazapine at 11th Floor (5th Offi...
Mirtazapine (USP/Ph.Eur)
Issue/Submission Date
2002-06-11
2022-12-19
2019-05-15
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

22889
Active
ARIPIPRAZOLE USP (ANHYDROUS FORM - ...
2009-06-24
CEP/COS

Found CEP/COS

R0-CEP 2017-289 - Rev 02
Valid
Aripiprazole, Form B
2023-03-24
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037A3-A4
Valid
Aripiprazole Monohydrate IH
2022-06-14
Application Number
22889
Indian CDSCO WC-0037A3-A4
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ARIPIPRAZOLE USP (ANHYDROUS FORM - ...
Aripiprazole, Form B
Aripiprazole Monohydrate IH
Issue/Submission Date
2009-06-24
2023-03-24
2022-06-14
See all info for this product

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USDMF

Found USDMF

13250
Active
CIPROFLOXACIN HYDROCHLORIDE USP
1998-09-29
CEP/COS

Found CEP/COS

CEP 2000-405 - Rev 12
Valid
Ciprofloxacin Hydrochloride
2023-11-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Ciprofloxacin Hydrochloride (USP/Ph...
2022-06-08
Application Number
13250
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
CIPROFLOXACIN HYDROCHLORIDE USP
Ciprofloxacin Hydrochloride
Ciprofloxacin Hydrochloride (USP/Ph...
Issue/Submission Date
1998-09-29
2023-11-28
2022-06-08
See all info for this product

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USDMF

Found USDMF

25733
Active
DEFERASIROX
2012-01-26
CEP/COS

Found CEP/COS

CEP 2020-280 - Rev 02
Valid
Deferasirox
2024-03-20
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Deferasirox (IH)
2022-06-08
Application Number
25733
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
DEFERASIROX
Deferasirox
Deferasirox (IH)
Issue/Submission Date
2012-01-26
2024-03-20
2022-06-08
See all info for this product

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USDMF

Found USDMF

21132
Active
DONEPEZIL HYDROCHLORIDE USP (FORM-I...
2007-12-11
CEP/COS

Found CEP/COS

CEP 2019-311 - Rev 01
Valid
Donepezil hydrochloride monohydrate...
2024-01-31
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Donepezil Hydrochloride (11-4/Ph.Eu...
2022-07-28
Application Number
21132
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
DONEPEZIL HYDROCHLORIDE USP (FORM-I...
Donepezil hydrochloride monohydrate...
Donepezil Hydrochloride (11-4/Ph.Eu...
Issue/Submission Date
2007-12-11
2024-01-31
2022-07-28
See all info for this product

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USDMF

Found USDMF

21519
Active
DORZOLAMIDE HYDROCHLORIDE FORM II U...
2008-04-09
CEP/COS

Found CEP/COS

R1-CEP 2017-089 - Rev 00
Valid
Dorzolamide hydrochloride, Process ...
2022-08-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Dorzolamide Hydrochloride (USP/Ph.E...
2022-07-28
Application Number
21519
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
DORZOLAMIDE HYDROCHLORIDE FORM II U...
Dorzolamide hydrochloride, Process ...
Dorzolamide Hydrochloride (USP/Ph.E...
Issue/Submission Date
2008-04-09
2022-08-22
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

21526
Active
ENTACAPONE USP (FORM-A)
2008-04-11
CEP/COS

Found CEP/COS

R1-CEP 2011-191 - Rev 04
Valid
Entacapone, Form-A
2023-03-24
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Entacapone (USP/Ph. Eur.)
2022-06-08
Application Number
21526
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ENTACAPONE USP (FORM-A)
Entacapone, Form-A
Entacapone (USP/Ph. Eur.)
Issue/Submission Date
2008-04-11
2023-03-24
2022-06-08
See all info for this product

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USDMF

Found USDMF

19662
Active
ESCITALOPRAM OXALATE
2006-08-07
CEP/COS

Found CEP/COS

R1-CEP 2017-217 - Rev 00
Valid
Escitalopram oxalate
2023-07-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036A2
Valid
Escitalopram Oxalate Ph. Eur.
2022-06-17
Application Number
19662
Indian CDSCO WC-0036A2
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ESCITALOPRAM OXALATE
Escitalopram oxalate
Escitalopram Oxalate Ph. Eur.
Issue/Submission Date
2006-08-07
2023-07-06
2022-06-17
See all info for this product

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USDMF

Found USDMF

15130
Active
IPRATROPIUM BROMIDE USP
2000-11-06
CEP/COS

Found CEP/COS

R1-CEP 2012-126 - Rev 02
Valid
Ipratropium bromide
2023-04-14
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ipratropium Bromide (USP/Ph.Eur)
2022-07-28
Application Number
15130
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
IPRATROPIUM BROMIDE USP
Ipratropium bromide
Ipratropium Bromide (USP/Ph.Eur)
Issue/Submission Date
2000-11-06
2023-04-14
2022-07-28
URL Supplier Web Content
See all info for this product

See Less

USDMF

Found USDMF

15445
Active
ITRACONAZOLE USP
2001-05-15
CEP/COS

Found CEP/COS

R1-CEP 2003-220 - Rev 06
Valid
Itraconazole
2021-09-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Itraconazole (USP/Ph.Eur)
2022-07-28
Application Number
15445
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
ITRACONAZOLE USP
Itraconazole
Itraconazole (USP/Ph.Eur)
Issue/Submission Date
2001-05-15
2021-09-07
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

30564
Active
LABETALOL HYDROCHLORIDE USP
2016-06-07
CEP/COS

Found CEP/COS

R0-CEP 2016-222 - Rev 03
Valid
Labetalol Hydrochloride
2023-03-27
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Labetalol HCl USP/EP
2022-06-08
Application Number
30564
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
LABETALOL HYDROCHLORIDE USP
Labetalol Hydrochloride
Labetalol HCl USP/EP
Issue/Submission Date
2016-06-07
2023-03-27
2022-06-08
URL Supplier Web Content
See all info for this product

See Less

USDMF

Found USDMF

15433
Active
OFLOXACIN USP
2001-05-15
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10618
Ofloxacin at 204, ⅠⅠ Floor, Mer...
2006-07-03
Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ofloxacin (USP/Ph.Eur)
2022-07-28
Application Number
15433
218MF10618
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
OFLOXACIN USP
Ofloxacin at 204, ⅠⅠ Floor, Mer...
Ofloxacin (USP/Ph.Eur)
Issue/Submission Date
2001-05-15
2006-07-03
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

19282
Active
OLANZAPINE FORM-1 USP
2006-03-24
CEP/COS

Found CEP/COS

R1-CEP 2012-190 - Rev 01
Valid
Olanzapine, Form-1
2021-09-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Olanzapine (Ph. Eur)
2022-07-28
Application Number
19282
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
OLANZAPINE FORM-1 USP
Olanzapine, Form-1
Olanzapine (Ph. Eur)
Issue/Submission Date
2006-03-24
2021-09-07
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

27418
Active
PROPOFOL USP
2013-08-13
CEP/COS

Found CEP/COS

CEP 2013-202 - Rev 03
Valid
Propofol
2024-01-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Propofol (USP/Ph. Eur.)
2022-06-08
Application Number
27418
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
PROPOFOL USP
Propofol
Propofol (USP/Ph. Eur.)
Issue/Submission Date
2013-08-13
2024-01-17
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

16647
Active
RAMIPRIL USP
2003-06-10
CEP/COS

Found CEP/COS

R1-CEP 2003-219 - Rev 07
Valid
Ramipril
2022-12-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ramipril (USP/Ph.Eur)
2022-07-28
Application Number
16647
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
RAMIPRIL USP
Ramipril
Ramipril (USP/Ph.Eur)
Issue/Submission Date
2003-06-10
2022-12-16
2022-07-28
See all info for this product

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USDMF

Found USDMF

30609
Active
RIVAROXABAN
2016-09-28
CEP/COS

Found CEP/COS

R0-CEP 2021-045 - Rev 00
Valid
Rivaroxaban
2023-06-23
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Rivaroxaban IH
2022-06-08
Application Number
30609
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
RIVAROXABAN
Rivaroxaban
Rivaroxaban IH
Issue/Submission Date
2016-09-28
2023-06-23
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

19590
Active
ROPINIROLE HYDROCHLORIDE USP
2006-07-10
CEP/COS

Found CEP/COS

R0-CEP 2017-219 - Rev 02
Valid
Ropinirole hydrochloride
2023-01-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ropinirole Hydrochloride (1H)
2022-07-28
Application Number
19590
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
ROPINIROLE HYDROCHLORIDE USP
Ropinirole hydrochloride
Ropinirole Hydrochloride (1H)
Issue/Submission Date
2006-07-10
2023-01-17
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

10253
Active
BENZYL ALBUTEROL, INTERMEDIATE
1993-05-12
CEP/COS

Found CEP/COS

R1-CEP 2000-143 - Rev 07
Valid
Salbutamol sulfate
2022-03-15
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Albuterol Sulfate USP/Salbutamol Su...
2022-07-28
Application Number
10253
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
BENZYL ALBUTEROL, INTERMEDIATE
Salbutamol sulfate
Albuterol Sulfate USP/Salbutamol Su...
Issue/Submission Date
1993-05-12
2022-03-15
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

22973
Active
SALMETEROL XINAFOATE USP
2009-07-22
CEP/COS

Found CEP/COS

CEP 2011-277 - Rev 03
Valid
Salmeterol xinafoate
2023-09-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
SalmeteroIXinafoate (USP/Ph.Eur
2022-07-28
Application Number
22973
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
SALMETEROL XINAFOATE USP
Salmeterol xinafoate
SalmeteroIXinafoate (USP/Ph.Eur
Issue/Submission Date
2009-07-22
2023-09-12
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

14951
Active
SOTALOL HYDROCHLORIDE USP
2000-07-13
CEP/COS

Found CEP/COS

CEP 2001-269 - Rev 09
Valid
Sotalol hydrochloride
2024-03-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
SOTALOL HCI USP/EP
2022-06-08
Application Number
14951
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
SOTALOL HYDROCHLORIDE USP
Sotalol hydrochloride
SOTALOL HCI USP/EP
Issue/Submission Date
2000-07-13
2024-03-06
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

23697
Active
VORICONAZOLE USP
2010-04-07
CEP/COS

Found CEP/COS

R1-CEP 2013-203 - Rev 02
Valid
Voriconazole
2023-03-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Voriconazole (Ph. Eur/USP)
2022-06-08
Application Number
23697
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-06-16
Filing Details
VORICONAZOLE USP
Voriconazole
Voriconazole (Ph. Eur/USP)
Issue/Submission Date
2010-04-07
2023-03-28
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

32684
Active
ROTIGOTINE USP
2018-03-31
CEP/COS

Found CEP/COS

R0-CEP 2020-010 - Rev 03
Valid
Rotigotine
2023-03-29
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0036A3
Expired
Rotigotine IH
2020-05-19
Application Number
32684
Indian CDSCO WC-0036A3
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-16
Filing Details
ROTIGOTINE USP
Rotigotine
Rotigotine IH
Issue/Submission Date
2018-03-31
2023-03-29
2020-05-19
See all info for this product

See Less

USDMF

Found USDMF

32422
Active
APIXABAN
2018-01-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Apixaban IH
2022-06-08
Application Number
32422
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
APIXABAN
Apixaban IH
Issue/Submission Date
2018-01-31
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

32953
Active
APREMILAST
2018-11-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Apremilast IH
2022-06-08
Application Number
32953
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
APREMILAST
Apremilast IH
Issue/Submission Date
2018-11-06
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

36451
Active
ARIPIPRAZOLE MONOHYDRATE (STERILE)
2021-11-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Aripiprazole USP/EP/IH
2022-06-08
Application Number
36451
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
ARIPIPRAZOLE MONOHYDRATE (STERILE)
Aripiprazole USP/EP/IH
Issue/Submission Date
2021-11-06
2022-06-08
URL Supplier Web Content
See all info for this product

See Less

USDMF

Found USDMF

26038
Active
BOSENTAN MONOHYDRATE
2012-05-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Bosentan Monohydrate (IH)
2022-06-08
Application Number
26038
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
BOSENTAN MONOHYDRATE
Bosentan Monohydrate (IH)
Issue/Submission Date
2012-05-09
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

25817
Active
BRINZOLAMIDE, USP
2012-02-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Brinzolamide (USP)
2022-06-08
Application Number
25817
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
BRINZOLAMIDE, USP
Brinzolamide (USP)
Issue/Submission Date
2012-02-22
2022-06-08
See all info for this product

See Less

USDMF

Found USDMF

28352
Active
DABIGATRAN ETEXILATE MESYLATE (FORM...
2014-07-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Dabigatran Etaxilate Mesilate (IH)
2022-06-08
Application Number
28352
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
DABIGATRAN ETEXILATE MESYLATE (FORM...
Dabigatran Etaxilate Mesilate (IH)
Issue/Submission Date
2014-07-07
2022-06-08
See all info for this product

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USDMF

Found USDMF

35172
Active
DONEPEZIL BASE
2020-10-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036A2
Valid
Donepezil Hydrochloride Monohydrate...
2022-06-17
Application Number
35172
Indian CDSCO WC-0036A2
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
DONEPEZIL BASE
Donepezil Hydrochloride Monohydrate...
Issue/Submission Date
2020-10-05
2022-06-17
See all info for this product

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USDMF

Found USDMF

33024
Active
DORZOLAMIDE HYDROCHLORIDE USP (PROC...
2018-11-19
CEP/COS

Found CEP/COS

R1-CEP 2008-155 - Rev 03
Valid
Dorzolamide hydrochloride
2021-09-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33024
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DORZOLAMIDE HYDROCHLORIDE USP (PROC...
Dorzolamide hydrochloride
Issue/Submission Date
2018-11-19
2021-09-07
See all info for this product

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USDMF

Found USDMF

35204
Active
EDARAVONE
2020-09-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037A3-A4
Valid
Edaravone IH
2022-06-14
Application Number
35204
Indian CDSCO WC-0037A3-A4
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
EDARAVONE
Edaravone IH
Issue/Submission Date
2020-09-29
2022-06-14
See all info for this product

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USDMF

Found USDMF

19984
Active
ENALAPRIL MALEATE USP
2006-11-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Enalapril Maleate (USP/Ph. Eur)
2022-06-08
Application Number
19984
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
ENALAPRIL MALEATE USP
Enalapril Maleate (USP/Ph. Eur)
Issue/Submission Date
2006-11-17
2022-06-08
See all info for this product

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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R0-CEP 2019-096 - Rev 03
Valid
Escitalopram oxalate, Process-II
2023-03-24
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Escitalopram Oxalate (IH/ USP)
2022-07-28
Application Number
Indian CDSCO WC-0036
Status
Valid
 
Valid
2025-06-16
Filing Details
Escitalopram oxalate, Process-II
Escitalopram Oxalate (IH/ USP)
Issue/Submission Date
2023-03-24
2022-07-28
URL Supplier Web Content
See all info for this product

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USDMF

Found USDMF

27473
Active
ETHACRYNIC ACID USP
2013-09-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ethacrynic Acid (USP)
2022-07-28
Application Number
27473
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
ETHACRYNIC ACID USP
Ethacrynic Acid (USP)
Issue/Submission Date
2013-09-03
2022-07-28
See all info for this product

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USDMF

Found USDMF

25543
Active
EZETIMIBE USP (FORM-X)
2011-11-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037A3-A4
Valid
Ezetimibe USP
2022-06-14
Application Number
25543
Indian CDSCO WC-0037A3-A4
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
EZETIMIBE USP (FORM-X)
Ezetimibe USP
Issue/Submission Date
2011-11-30
2022-06-14
See all info for this product

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USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2019-023 - Rev 04
Valid
Levofloxacin hemihydrate
2023-11-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036A2
Valid
Levofloxacin Hernihydrate Ph. Eur.
2022-06-17
Application Number
Indian CDSCO WC-0036A2
Status
Valid
 
Valid
2025-06-16
Filing Details
Levofloxacin hemihydrate
Levofloxacin Hernihydrate Ph. Eur.
Issue/Submission Date
2023-11-07
2022-06-17
See all info for this product

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USDMF

Found USDMF

24506
Active
LINEZOLID USP (FORM-II)
2010-12-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Linezolid (IH)
2022-06-08
Application Number
24506
Indian CDSCO WC-0037
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
LINEZOLID USP (FORM-II)
Linezolid (IH)
Issue/Submission Date
2010-12-29
2022-06-08
See all info for this product

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USDMF

Found USDMF

36946
Active
LINEZOLID USP (PROCESS-II)
2022-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037A3-A4
Valid
Linezolid USP
2022-06-14
Application Number
36946
Indian CDSCO WC-0037A3-A4
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
LINEZOLID USP (PROCESS-II)
Linezolid USP
Issue/Submission Date
2022-03-31
2022-06-14
See all info for this product

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USDMF

Found USDMF

24022
Active
MIRTAZAPINE, USP (ANHYDROUS)
2010-08-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Mirtazapine USP/Ph.Eur
2022-06-08
Application Number
24022
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
MIRTAZAPINE, USP (ANHYDROUS)
Mirtazapine USP/Ph.Eur
Issue/Submission Date
2010-08-04
2022-06-08
URL Supplier Web Content
See all info for this product

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USDMF

Found USDMF

18789
Active
MOXIFLOXACIN HYDROCHLORIDE MONOHYDR...
2005-09-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Moxifloxacin hydrochloride (USP/Ph....
2022-07-28
Application Number
18789
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
MOXIFLOXACIN HYDROCHLORIDE MONOHYDR...
Moxifloxacin hydrochloride (USP/Ph....
Issue/Submission Date
2005-09-19
2022-07-28
See all info for this product

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USDMF

Found USDMF

26195
Active
PALIPERIDONE PALMITATE
2012-07-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0478
Valid
Paliperidone Palmitate sterile IH
2023-06-23
Application Number
26195
Indian CDSCO WC-0478
Status
Active
Fees Paid
N/A
 
Valid
2026-06-29
Filing Details
PALIPERIDONE PALMITATE
Paliperidone Palmitate sterile IH
Issue/Submission Date
2012-07-02
2023-06-23
See all info for this product

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USDMF

Found USDMF

32435
Active
PALIPERIDONE PALMITATE STERILE
2018-03-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Paliperidone Palmitate (IH
2022-07-28
Application Number
32435
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
PALIPERIDONE PALMITATE STERILE
Paliperidone Palmitate (IH
Issue/Submission Date
2018-03-30
2022-07-28
URL Supplier Web Content
See all info for this product

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USDMF

Found USDMF

21123
Active
PALONOSETRON HYDROCHLORIDE
2007-12-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Palonosetron HCl IH
2022-07-28
Application Number
21123
Indian CDSCO WC-0036
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
PALONOSETRON HYDROCHLORIDE
Palonosetron HCl IH
Issue/Submission Date
2007-12-11
2022-07-28
See all info for this product

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USDMF

Found USDMF

28826
Active
POSACONAZOLE
2018-05-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Posaconazole (IH)
2022-07-28
Application Number
28826
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
POSACONAZOLE
Posaconazole (IH)
Issue/Submission Date
2018-05-03
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

26414
Active
ROPINIROLE
2012-09-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0036
Valid
Ropinirole Base (IH)
2022-07-28
Application Number
26414
Indian CDSCO WC-0036
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
ROPINIROLE
Ropinirole Base (IH)
Issue/Submission Date
2012-09-14
2022-07-28
See all info for this product

See Less

USDMF

Found USDMF

36341
Active
TAFAMIDIS MEGLUMINE
2021-11-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037A3-A4
Valid
Tafamidis Meglumine IH
2022-06-14
Application Number
36341
Indian CDSCO WC-0037A3-A4
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
TAFAMIDIS MEGLUMINE
Tafamidis Meglumine IH
Issue/Submission Date
2021-11-03
2022-06-14
See all info for this product

See Less

USDMF

Found USDMF

33748
Active
TICAGRELOR FORM-II
2019-04-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0037
Valid
Ticagrelor IH
2022-06-08
Application Number
33748
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
TICAGRELOR FORM-II
Ticagrelor IH
Issue/Submission Date
2019-04-19
2022-06-08
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