Bora CDMO Bora CDMO

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Unimark Remedies Limited

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Unimark Remedies Limited
india-flag Flag
Country
Country
India
Address
Address
Enterprise Center,1st Floor, Orchid lane, Nehru Road, Vile Parle (East), Mumbai- 400099
Telephone
Telephone
+91 22 67304000/101 (Board)
Linkedin
Linkedin
Twitter
Twitter

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USDMF

Found USDMF

19479
Active
BENAZEPRIL HYDROCHLORIDE USP
2006-05-31
CEP/COS

Found CEP/COS

R1-CEP 2008-273 - Rev 00
Valid
Benazepril hydrochloride
2015-04-15
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Benazepril Hydrochloride (EP/BP/USP...
2019-07-22
Application Number
19479
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
BENAZEPRIL HYDROCHLORIDE USP
Benazepril hydrochloride
Benazepril Hydrochloride (EP/BP/USP...
Issue/Submission Date
2006-05-31
2015-04-15
2019-07-22
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USDMF

Found USDMF

20545
Active
CEFUROXIME AXETIL USP
2007-05-23
CEP/COS

Found CEP/COS

R1-CEP 2007-198 - Rev 01
Valid
Cefuroxime axetil
2015-07-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0342
Expired
Cefuroxime Axetil (USP)
2015-08-25
Application Number
20545
Indian CDSCO WC-0342
Status
Active
Fees Paid
N/A
Valid
 
Expired
2018-08-25
Filing Details
CEFUROXIME AXETIL USP
Cefuroxime axetil
Cefuroxime Axetil (USP)
Issue/Submission Date
2007-05-23
2015-07-17
2015-08-25
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USDMF

Found USDMF

19272
Active
FLECAINIDE ACETATE USP
2006-03-23
CEP/COS

Found CEP/COS

R1-CEP 2009-289 - Rev 01
Valid
Flecainide acetate, Process A
2015-03-19
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Flecainide Acetate (BP/EP/USP)
2019-07-22
Application Number
19272
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
FLECAINIDE ACETATE USP
Flecainide acetate, Process A
Flecainide Acetate (BP/EP/USP)
Issue/Submission Date
2006-03-23
2015-03-19
2019-07-22
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USDMF

Found USDMF

17626
Active
LISINOPRIL USP
2004-08-26
CEP/COS

Found CEP/COS

R1-CEP 2004-063 - Rev 04
Valid
Lisinopril dihydrate
2020-03-11
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Lisinopril (USP/IP/BP/EP)
2019-07-22
Application Number
17626
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
LISINOPRIL USP
Lisinopril dihydrate
Lisinopril (USP/IP/BP/EP)
Issue/Submission Date
2004-08-26
2020-03-11
2019-07-22
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USDMF

Found USDMF

18286
Active
MELOXICAM USP
2005-04-19
CEP/COS

Found CEP/COS

R1-CEP 2008-301 - Rev 00
Valid
Meloxicam
2015-07-29
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Meloxicam (BP/USP)
2019-07-22
Application Number
18286
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
MELOXICAM USP
Meloxicam
Meloxicam (BP/USP)
Issue/Submission Date
2005-04-19
2015-07-29
2019-07-22
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USDMF

Found USDMF

23500
Active
NITROFURANTOIN ANHYDROUS USP
2010-02-16
CEP/COS

Found CEP/COS

R1-CEP 2011-108 - Rev 01
Valid
Nitrofurantoin
2020-09-23
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Nitrofurantoin (IP/EP/USP)
2019-07-22
Application Number
23500
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
NITROFURANTOIN ANHYDROUS USP
Nitrofurantoin
Nitrofurantoin (IP/EP/USP)
Issue/Submission Date
2010-02-16
2020-09-23
2019-07-22
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USDMF

Found USDMF

17754
Active
ALBENDAZOLE USP
2004-11-08
CEP/COS

Caution CEP/COS

R1-CEP 2001-448 - Rev 04
Withdrawn by EDQM Failure to CEP procedure
Albendazole
2014-04-28
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Albendazole IP/BP/EP/USP
2019-07-22
Application Number
17754
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Expired
2022-07-21
Filing Details
ALBENDAZOLE USP
Albendazole
Albendazole IP/BP/EP/USP
Issue/Submission Date
2004-11-08
2014-04-28
2019-07-22
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USDMF

Found USDMF

25361
Active
BUSPIRONE HYDROCHLORIDE USP
2011-11-16
CEP/COS

Caution CEP/COS

R0-CEP 2012-361 - Rev 00
Expired
Buspirone hydrochloride
2014-11-13
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Busipirone Hydrochloride (IP/USP)
2019-07-22
Application Number
25361
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
Expired
 
Expired
2022-07-21
Filing Details
BUSPIRONE HYDROCHLORIDE USP
Buspirone hydrochloride
Busipirone Hydrochloride (IP/USP)
Issue/Submission Date
2011-11-16
2014-11-13
2019-07-22
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USDMF

Found USDMF

26047
Active
CEFIXIME USP
2012-06-08
CEP/COS

Caution CEP/COS

R1-CEP 2008-124 - Rev 00
Withdrawn by EDQM Failure to CEP procedure
Cefixime
2015-11-20
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0342
Expired
Cefixime (USP)
2015-08-25
Application Number
26047
Indian CDSCO WC-0342
Status
Active
Fees Paid
Reviewed
Withdrawn by EDQM Failure to CEP procedure
 
Expired
2018-08-25
Filing Details
CEFIXIME USP
Cefixime
Cefixime (USP)
Issue/Submission Date
2012-06-08
2015-11-20
2015-08-25
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USDMF

Found USDMF

23192
Active
FLECAINIDE ACETATE USP (PROCESS B)
2009-10-14
CEP/COS

Found CEP/COS

R1-CEP 2006-005 - Rev 02
Valid
Flecainide acetate
2020-08-13
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23192
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FLECAINIDE ACETATE USP (PROCESS B)
Flecainide acetate
Issue/Submission Date
2009-10-14
2020-08-13
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USDMF

Caution USDMF

20564
Inactive
MONTELUKAST SODIUM
2007-05-31
CEP/COS

Found CEP/COS

R1-CEP 2012-288 - Rev 00
Valid
Montelukast sodium
2021-07-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Montelukast Sodium (EP)
2019-07-22
Application Number
20564
Indian CDSCO WC-0170
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
MONTELUKAST SODIUM
Montelukast sodium
Montelukast Sodium (EP)
Issue/Submission Date
2007-05-31
2021-07-07
2019-07-22
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USDMF

Found USDMF

23501
Active
NITROFURANTOIN MONOHYDRATE USP
2010-02-16
CEP/COS

Found CEP/COS

R1-CEP 2014-226 - Rev 00
Valid
Nitrofurantoin, Macrocrystals
2021-10-06
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23501
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NITROFURANTOIN MONOHYDRATE USP
Nitrofurantoin, Macrocrystals
Issue/Submission Date
2010-02-16
2021-10-06
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USDMF

Found USDMF

19522
Active
RAMIPRIL USP
2006-06-15
CEP/COS

Caution CEP/COS

R1-CEP 2006-006 - Rev 01
Withdrawn by EDQM Failure to CEP procedure
Ramipril
2013-01-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Ramipril (BP/USP/EP)
2019-07-22
Application Number
19522
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Expired
2022-07-21
Filing Details
RAMIPRIL USP
Ramipril
Ramipril (BP/USP/EP)
Issue/Submission Date
2006-06-15
2013-01-07
2019-07-22
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USDMF

Found USDMF

24945
Active
ARMODAFINIL
2011-06-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Armodafinil Bulk (IH)
2019-07-22
Application Number
24945
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
ARMODAFINIL
Armodafinil Bulk (IH)
Issue/Submission Date
2011-06-01
2019-07-22
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2005-092 - Rev 01
Valid
Cefaclor
2011-10-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0342
Expired
Cefaclor (EP)
2015-08-25
Application Number
Indian CDSCO WC-0342
Status
Valid
 
Expired
2018-08-25
Filing Details
Cefaclor
Cefaclor (EP)
Issue/Submission Date
2011-10-17
2015-08-25
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2004-064 - Rev 00
Valid
Cefalexin monohydrate
2011-01-24
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0342
Expired
Cephalexin Monohydrate (USP)
2015-08-25
Application Number
Indian CDSCO WC-0342
Status
Valid
 
Expired
2018-08-25
Filing Details
Cefalexin monohydrate
Cephalexin Monohydrate (USP)
Issue/Submission Date
2011-01-24
2015-08-25
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USDMF

Found USDMF

25669
Active
DRONEDARONE HYDROCHLORIDE
2012-02-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Dronedarone Hydrochloride (IH)
2019-07-22
Application Number
25669
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
DRONEDARONE HYDROCHLORIDE
Dronedarone Hydrochloride (IH)
Issue/Submission Date
2012-02-16
2019-07-22
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USDMF

Found USDMF

25761
Active
FEBUXOSTATE
2012-02-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Febuxostat (IH)
2019-07-22
Application Number
25761
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
FEBUXOSTATE
Febuxostat (IH)
Issue/Submission Date
2012-02-24
2019-07-22
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USDMF

Found USDMF

22813
Active
LAMOTRIGINE USP
2009-05-25
CEP/COS

Caution CEP/COS

R1-CEP 2009-278 - Rev 00
Withdrawn by EDQM Failure to CEP procedure
Lamotrigine
2016-02-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22813
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Filing Details
LAMOTRIGINE USP
Lamotrigine
Issue/Submission Date
2009-05-25
2016-02-26
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USDMF

Found USDMF

23254
Active
LANTHANUM CARBONATE OCTAHYDRATE
2009-11-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Lanthanum Carbonate (IH)
2019-07-22
Application Number
23254
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
LANTHANUM CARBONATE OCTAHYDRATE
Lanthanum Carbonate (IH)
Issue/Submission Date
2009-11-05
2019-07-22
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USDMF

Found USDMF

25869
Active
MEROPENEM TECHNICAL
2012-03-31
CEP/COS

Caution CEP/COS

R0-CEP 2015-148 - Rev 00
Withdrawn by EDQM Failure to CEP procedure
Meropenem trihydrate, Sterile, synt...
2017-08-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25869
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Filing Details
MEROPENEM TECHNICAL
Meropenem trihydrate, Sterile, synt...
Issue/Submission Date
2012-03-31
2017-08-23
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USDMF

Found USDMF

25362
Active
MOXIFLOXACIN HYDROCHLORIDE USP
2011-10-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Moxifloxacin Hydrochloride (EP/USP)
2019-07-22
Application Number
25362
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
MOXIFLOXACIN HYDROCHLORIDE USP
Moxifloxacin Hydrochloride (EP/USP)
Issue/Submission Date
2011-10-25
2019-07-22
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USDMF

Found USDMF

23338
Active
PALIPERIDONE
2010-02-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Paliperidone (IH)
2019-07-22
Application Number
23338
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
PALIPERIDONE
Paliperidone (IH)
Issue/Submission Date
2010-02-20
2019-07-22
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USDMF

Found USDMF

22747
Active
PIMOZIDE USP [TYPE-2]
2009-04-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Pimozide (USP)
2019-07-22
Application Number
22747
Indian CDSCO WC-0170
Status
Active
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
PIMOZIDE USP [TYPE-2]
Pimozide (USP)
Issue/Submission Date
2009-04-23
2019-07-22
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USDMF

Found USDMF

24177
Active
RIZATRIPTAN BENZOATE
2010-09-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Rizatriptan Benzoate (IH)
2019-07-22
Application Number
24177
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
RIZATRIPTAN BENZOATE
Rizatriptan Benzoate (IH)
Issue/Submission Date
2010-09-27
2019-07-22
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USDMF

Found USDMF

20121
Active
7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXY...
2007-01-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20121
Status
Active
Fees Paid
N/A
 
Filing Details
7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXY...
Issue/Submission Date
2007-01-09
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USDMF

Caution USDMF

23775
Inactive
CANDESARTAN CILEXETIL
2010-05-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Candesartan Cilexetil (IH)
2019-07-22
Application Number
23775
Indian CDSCO WC-0170
Status
Inactive
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
CANDESARTAN CILEXETIL
Candesartan Cilexetil (IH)
Issue/Submission Date
2010-05-12
2019-07-22
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USDMF

Found USDMF

28321
Active
CILASTATIN ACID (INTERMEDIATE)
2014-06-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28321
Status
Active
Fees Paid
N/A
 
Filing Details
CILASTATIN ACID (INTERMEDIATE)
Issue/Submission Date
2014-06-03
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USDMF

Found USDMF

28365
Active
CILASTATIN SODIUM USP (STERILE)
2014-06-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28365
Status
Active
Fees Paid
Reviewed
 
Filing Details
CILASTATIN SODIUM USP (STERILE)
Issue/Submission Date
2014-06-12
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USDMF

Found USDMF

28210
Active
DORIPENEM CRUDE (INTERMEDIATE)
2014-04-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28210
Status
Active
Fees Paid
N/A
 
Filing Details
DORIPENEM CRUDE (INTERMEDIATE)
Issue/Submission Date
2014-04-25
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USDMF

Found USDMF

28280
Active
DORIPENEM STERILE
2014-05-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28280
Status
Active
Fees Paid
Reviewed
 
Filing Details
DORIPENEM STERILE
Issue/Submission Date
2014-05-30
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USDMF

Caution USDMF

23593
Inactive
HYDROXYCHLOROQUINE SULFATE USP
2010-03-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Hydroxychloroquine Sulphate (BP/USP...
2019-07-22
Application Number
23593
Indian CDSCO WC-0170
Status
Inactive
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
HYDROXYCHLOROQUINE SULFATE USP
Hydroxychloroquine Sulphate (BP/USP...
Issue/Submission Date
2010-03-12
2019-07-22
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USDMF

Found USDMF

28296
Active
IMIPENEM CRUDE (INTERMEDIATE)
2014-05-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28296
Status
Active
Fees Paid
N/A
 
Filing Details
IMIPENEM CRUDE (INTERMEDIATE)
Issue/Submission Date
2014-05-23
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USDMF

Found USDMF

28356
Active
IMIPENEM USP (STERILE)
2014-06-16
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
28356
Status
Active
Fees Paid
Reviewed
 
Filing Details
IMIPENEM USP (STERILE)
Issue/Submission Date
2014-06-16
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USDMF

Found USDMF

28279
Active
MEROPENEM USP (STERILE)
2014-06-07
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
28279
Status
Active
Fees Paid
Reviewed
 
Filing Details
MEROPENEM USP (STERILE)
Issue/Submission Date
2014-06-07
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USDMF

Found USDMF

24324
Active
MONTELUKAST SODIUM (PROCESS B)
2010-11-02
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24324
Status
Active
Fees Paid
N/A
 
Filing Details
MONTELUKAST SODIUM (PROCESS B)
Issue/Submission Date
2010-11-02
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USDMF

Caution USDMF

21893
Inactive
MONTELUKAST SODIUM (NI)
2008-08-14
CEP/COS

Caution CEP/COS

R0-CEP 2012-331 - Rev 00
Expired
Montelukast sodium, Process B
2015-01-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21893
Status
Inactive
Fees Paid
N/A
Expired
 
Filing Details
MONTELUKAST SODIUM (NI)
Montelukast sodium, Process B
Issue/Submission Date
2008-08-14
2015-01-23
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R1-CEP 2011-088 - Rev 00
Withdrawn by EDQM Failure to CEP procedure
Nalidixic Acid - Text Deleted 1/01/...
2016-06-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Nalidixic Acid (EP/BP/USP)
2019-07-22
Application Number
Indian CDSCO WC-0170
Status
Withdrawn by EDQM Failure to CEP procedure
 
Expired
2022-07-21
Filing Details
Nalidixic Acid - Text Deleted 1/01/...
Nalidixic Acid (EP/BP/USP)
Issue/Submission Date
2016-06-17
2019-07-22
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2001-350 - Rev 02
Valid
Nimesulide
2011-06-15
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Nimesulide
Issue/Submission Date
2011-06-15
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USDMF

Found USDMF

23570
Active
NITROFURANTOIN ANHYDROUS CRYSTALS U...
2010-03-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23570
Status
Active
Fees Paid
N/A
 
Filing Details
NITROFURANTOIN ANHYDROUS CRYSTALS U...
Issue/Submission Date
2010-03-12
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USDMF

Found USDMF

26176
Active
NITROFURANTOIN ANHYDROUS USP (MACRO...
2012-06-28
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
26176
Status
Active
Fees Paid
Reviewed
 
Filing Details
NITROFURANTOIN ANHYDROUS USP (MACRO...
Issue/Submission Date
2012-06-28
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USDMF

Found USDMF

28381
Active
STERILE MIXTURE FOR IMIPENEM, CILAS...
2014-06-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28381
Status
Active
Fees Paid
N/A
 
Filing Details
STERILE MIXTURE FOR IMIPENEM, CILAS...
Issue/Submission Date
2014-06-18
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USDMF

Found USDMF

28382
Active
STERILE MIXTURE FOR MEROPENEM AND S...
2014-06-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28382
Status
Active
Fees Paid
N/A
 
Filing Details
STERILE MIXTURE FOR MEROPENEM AND S...
Issue/Submission Date
2014-06-19
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USDMF

Found USDMF

23965
Active
SOLIFENACIN SUCCINATE
2010-07-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23965
Status
Active
Fees Paid
Reviewed
 
Filing Details
SOLIFENACIN SUCCINATE
Issue/Submission Date
2010-07-28
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USDMF

Caution USDMF

26319
Inactive
TENOFOVIR DISOPROXIL FUMARATE
2012-08-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0170
Expired
Tenofovir Disoproxil Fumarate (IH)
2019-07-22
Application Number
26319
Indian CDSCO WC-0170
Status
Inactive
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
TENOFOVIR DISOPROXIL FUMARATE
Tenofovir Disoproxil Fumarate (IH)
Issue/Submission Date
2012-08-29
2019-07-22
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USDMF

Found USDMF

22247
Active
TIGECYCLINE TECHNICAL
2008-11-29
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
22247
Status
Active
Fees Paid
Reviewed
 
Filing Details
TIGECYCLINE TECHNICAL
Issue/Submission Date
2008-11-29
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USDMF

Found USDMF

20932
Active
TOPIRAMATE USP
2007-10-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20932
Status
Active
Fees Paid
Reviewed
 
Filing Details
TOPIRAMATE USP
Issue/Submission Date
2007-10-05
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USDMF

Found USDMF

23349
Active
TOPIRAMATE USP (PROCESS A)
2009-11-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23349
Status
Active
Fees Paid
Reviewed
 
Filing Details
TOPIRAMATE USP (PROCESS A)
Issue/Submission Date
2009-11-30
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USDMF

Caution USDMF

21471
Inactive
CEFPROZIL USP
2008-03-15
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
21471
Status
Inactive
Fees Paid
N/A
 
Filing Details
CEFPROZIL USP
Issue/Submission Date
2008-03-15
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USDMF

Caution USDMF

18361
Inactive
CEPHALEXIN USP
2005-05-20
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Close WC

Application Number
18361
Status
Inactive
Fees Paid
N/A
 
Filing Details
CEPHALEXIN USP
Issue/Submission Date
2005-05-20
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