Minakem Generic APIs Minakem Generic APIs

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Metrochem API Private Limited

  • Webinars & Exhibitions

  • Abrocitinib

  • Alogliptin Benzoate

  • Cenobamate

  • Dapagliflozin

  • Dapagliflozin Propanediol Monohydrate

  • Edoxaban Tosylate

  • Lacosamide

  • Lasmiditan

  • Lurasidone Hydrochloride

  • Mavacamten

  • Nintedanib Esylate

  • Ranolazine

  • Relugolix

  • Ritlecitinib

  • Tapinarof

  • Vigabatrin

  • Vonoprazan Fumarate

  • Vortioxetine Hydrobromide

  • Zavegepant HCl

PharmaCompass
Metrochem
Metrochem API Private Limited
india-flag Flag
Country
Country
India
Address
Address
The Watermark, 3rd floor & 4th floor, Plot No 11, Survey No. 9, Whitefields, Kondapur, Hitech City Hyderabad - 500084, Telangana
Telephone
Telephone
+91 4069069999
Contact Info
Others

ListList of Products
See all info for this product

See Less

USDMF

Found USDMF

34334
Active
CLOPIDOGREL BISULFATE USP
2020-02-05
CEP/COS

Found CEP/COS

CEP 2020-093 - Rev 01
Valid
Clopidogrel hydrogen sulfate
2024-06-20
Japanese DMF

Found JDMF

304MF10071
Clopidogrel Sulfate at Flat No. 302...
2022-05-12
Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Clopidogrel Bisulfate USP / Clopido...
2024-04-03
Application Number
34334
304MF10071
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
CLOPIDOGREL BISULFATE USP
Clopidogrel hydrogen sulfate
Clopidogrel Sulfate at Flat No. 302...
Clopidogrel Bisulfate USP / Clopido...
Issue/Submission Date
2020-02-05
2024-06-20
2022-05-12
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35485
Active
LANSOPRAZOLE USP
2020-12-22
CEP/COS

Found CEP/COS

CEP 2021-009 - Rev 02
Valid
Lansoprazole
2024-06-20
Japanese DMF

Found JDMF

223MF10044
Lansoprazole at Flat No. 302, Bhanu...
2011-03-22
Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Lansoprazole USP/EP at Unit-IV, Plo...
2024-04-03
Application Number
35485
223MF10044
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
LANSOPRAZOLE USP
Lansoprazole
Lansoprazole at Flat No. 302, Bhanu...
Lansoprazole USP/EP at Unit-IV, Plo...
Issue/Submission Date
2020-12-22
2024-06-20
2011-03-22
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35344
Active
RABEPRAZOLE SODIUM
2020-11-27
CEP/COS

Found CEP/COS

CEP 2020-387 - Rev 01
Valid
Rabeprazole sodium hydrate
2024-06-21
Japanese DMF

Found JDMF

221MF10282
Rabeprazole sodium at Flat No. 302,...
2009-12-22
Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
RABEPRAZOLE SDOIUM USP/Ph. Eur at U...
2024-04-03
Application Number
35344
221MF10282
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
Reviewed
Valid
 
Valid
2027-01-21
Filing Details
RABEPRAZOLE SODIUM
Rabeprazole sodium hydrate
Rabeprazole sodium at Flat No. 302,...
RABEPRAZOLE SDOIUM USP/Ph. Eur at U...
Issue/Submission Date
2020-11-27
2024-06-21
2009-12-22
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35400
Active
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
2020-11-28
CEP/COS

Found CEP/COS

CEP 2020-386 - Rev 01
Valid
Esomeprazole magnesium trihydrate
2024-06-14
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Esomeprazole Magnesium USP & Trihyd...
2024-04-03
Application Number
35400
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Esomeprazole magnesium trihydrate
Esomeprazole Magnesium USP & Trihyd...
Issue/Submission Date
2020-11-28
2024-06-14
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34731
Active
LEVOCETIRIZINE DIHYDROCHLORIDE USP
2020-05-12
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

302MF10110
Levocetirizine Hydrochloride at Fla...
2020-09-14
Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Levocetirizine Dihydrochloride USP ...
2024-04-03
Application Number
34731
302MF10110
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
LEVOCETIRIZINE DIHYDROCHLORIDE USP
Levocetirizine Hydrochloride at Fla...
Levocetirizine Dihydrochloride USP ...
Issue/Submission Date
2020-05-12
2020-09-14
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34759
Active
OMEPRAZOLE USP
2020-06-03
CEP/COS

Found CEP/COS

R0-CEP 2020-182 - Rev 00
Valid
Omeprazole
2022-05-25
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Omeprazole USP/Ph. Eur at Unit-IV, ...
2024-04-03
Application Number
34759
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
OMEPRAZOLE USP
Omeprazole
Omeprazole USP/Ph. Eur at Unit-IV, ...
Issue/Submission Date
2020-06-03
2022-05-25
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35390
Active
OMEPRAZOLE MAGNESIUM
2020-11-20
CEP/COS

Found CEP/COS

CEP 2020-380 - Rev 02
Valid
Omeprazole magnesium
2024-06-20
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Omeprazole Magnesium USP/Ph. Eur at...
2024-04-03
Application Number
35390
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
OMEPRAZOLE MAGNESIUM
Omeprazole magnesium
Omeprazole Magnesium USP/Ph. Eur at...
Issue/Submission Date
2020-11-20
2024-06-20
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35577
Active
PANTOPRAZOLE SODIUM
2021-03-29
CEP/COS

Found CEP/COS

CEP 2021-168 - Rev 01
Valid
Pantoprazole sodium sesquihydrate
2024-06-21
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Pantoprazole Sodium Sesquihydrate E...
2024-04-03
Application Number
35577
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
Valid
 
Valid
2027-01-21
Filing Details
PANTOPRAZOLE SODIUM
Pantoprazole sodium sesquihydrate
Pantoprazole Sodium Sesquihydrate E...
Issue/Submission Date
2021-03-29
2024-06-21
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35518
Active
APIXABAN
2020-12-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Apixaban IHS at Unit-IV, Plot No. 3...
2024-04-03
Application Number
35518
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
APIXABAN
Apixaban IHS at Unit-IV, Plot No. 3...
Issue/Submission Date
2020-12-30
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

36085
Active
BEMPEDOIC ACID
2021-07-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Bempedoic Acid IHS at Unit-IV, Plot...
2024-04-03
Application Number
36085
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
Reviewed
 
Valid
2027-01-21
Filing Details
BEMPEDOIC ACID
Bempedoic Acid IHS at Unit-IV, Plot...
Issue/Submission Date
2021-07-05
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

36962
Active
CUPRIC SULFATE PENTAHYDRATE USP
2022-06-14
CEP/COS

Found CEP/COS

CEP 2022-438 - Rev 01
Valid
Copper sulfate pentahydrate
2024-06-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36962
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
CUPRIC SULFATE PENTAHYDRATE USP
Copper sulfate pentahydrate
Issue/Submission Date
2022-06-14
2024-06-21
See all info for this product

See Less

USDMF

Found USDMF

36048
Active
DAPAGLIFLOZIN PROPENEDIOL MONOHYDRA...
2021-06-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Dapagliflozin Propanediol Monohydra...
2024-04-03
Application Number
36048
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
DAPAGLIFLOZIN PROPENEDIOL MONOHYDRA...
Dapagliflozin Propanediol Monohydra...
Issue/Submission Date
2021-06-28
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34732
Active
DEXKETOPROFEN TROMETAMOL
2020-03-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Dexketoprofen Trometamol IHS at Uni...
2024-04-03
Application Number
34732
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
DEXKETOPROFEN TROMETAMOL
Dexketoprofen Trometamol IHS at Uni...
Issue/Submission Date
2020-03-21
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34971
Active
DEXLANSOPRAZOLE
2020-09-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Dexlansoprazole IHS at Unit-IV, Plo...
2024-04-03
Application Number
34971
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
DEXLANSOPRAZOLE
Dexlansoprazole IHS at Unit-IV, Plo...
Issue/Submission Date
2020-09-29
2024-04-03
See all info for this product

See Less

USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2021-080 - Rev 01
Valid
Dimetindene maleate
2024-06-20
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Dimethindene Maleate EP at Unit-IV,...
2024-04-03
Application Number
Indian CDSCO WC-0493
Status
Valid
 
Valid
2027-01-21
Filing Details
Dimetindene maleate
Dimethindene Maleate EP at Unit-IV,...
Issue/Submission Date
2024-06-20
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35345
Active
EMPAGLIFLOZIN
2020-10-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Empagliflozin IHS at Unit-IV, Plot ...
2024-04-03
Application Number
35345
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
EMPAGLIFLOZIN
Empagliflozin IHS at Unit-IV, Plot ...
Issue/Submission Date
2020-10-31
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35519
Active
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
2020-12-29
CEP/COS

Found CEP/COS

CEP 2021-022 - Rev 01
Valid
Esomeprazole magnesium dihydrate
2024-06-20
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35519
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Esomeprazole magnesium dihydrate
Issue/Submission Date
2020-12-29
2024-06-20
See all info for this product

See Less

USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2020-214 - Rev 01
Valid
Esomeprazole sodium
2024-06-21
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Esomeprazole Sodium EP at Unit-IV, ...
2024-04-03
Application Number
Indian CDSCO WC-0493
Status
Valid
 
Valid
2027-01-21
Filing Details
Esomeprazole sodium
Esomeprazole Sodium EP at Unit-IV, ...
Issue/Submission Date
2024-06-21
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34537
Active
ETORICOXIB
2020-02-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Etoricoxib IHS at Unit-IV, Plot No....
2024-04-03
Application Number
34537
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
ETORICOXIB
Etoricoxib IHS at Unit-IV, Plot No....
Issue/Submission Date
2020-02-22
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35578
Active
FEBUXOSTAT
2021-02-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Febuxostat IHS at Unit-IV, Plot No....
2024-04-03
Application Number
35578
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
FEBUXOSTAT
Febuxostat IHS at Unit-IV, Plot No....
Issue/Submission Date
2021-02-13
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34756
Active
LURASIDONE HYDROCHLORIDE
2020-07-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Lurasidone Hydrochloride IHS at Uni...
2024-04-03
Application Number
34756
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
LURASIDONE HYDROCHLORIDE
Lurasidone Hydrochloride IHS at Uni...
Issue/Submission Date
2020-07-14
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

36960
Active
MANGANESE SULFATE MONOHYDRATE USP
2022-06-10
CEP/COS

Found CEP/COS

CEP 2022-464 - Rev 01
Valid
Manganese sulfate monohydrate
2024-06-24
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36960
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
MANGANESE SULFATE MONOHYDRATE USP
Manganese sulfate monohydrate
Issue/Submission Date
2022-06-10
2024-06-24
See all info for this product

See Less

USDMF

Found USDMF

34173
Active
OXICONAZOLE NITRATE
2019-09-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Oxiconazole Nitrate IHS at Unit-IV,...
2024-04-03
Application Number
34173
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
OXICONAZOLE NITRATE
Oxiconazole Nitrate IHS at Unit-IV,...
Issue/Submission Date
2019-09-23
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35487
Active
OZENOXACIN
2020-12-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Ozenoxacin IHS at Unit-IV, Plot No....
2024-04-03
Application Number
35487
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
OZENOXACIN
Ozenoxacin IHS at Unit-IV, Plot No....
Issue/Submission Date
2020-12-26
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35517
Active
POSACONAZOLE
2021-01-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Posaconazole IHS at Unit-IV, Plot N...
2024-04-03
Application Number
35517
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
POSACONAZOLE
Posaconazole IHS at Unit-IV, Plot N...
Issue/Submission Date
2021-01-11
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

34970
Active
PRUCALOPRIDE SUCCINATE
2020-08-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Prucalopride Succinate IHS at Unit-...
2024-04-03
Application Number
34970
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
Reviewed
 
Valid
2027-01-21
Filing Details
PRUCALOPRIDE SUCCINATE
Prucalopride Succinate IHS at Unit-...
Issue/Submission Date
2020-08-21
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

37630
Active
RABEPRAZOLE SODIUM (Y-FORM)
2022-11-14
CEP/COS

Found CEP/COS

CEP 2022-429 - Rev 01
Valid
Rabeprazole sodium hydrate, RBL pro...
2024-06-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37630
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
RABEPRAZOLE SODIUM (Y-FORM)
Rabeprazole sodium hydrate, RBL pro...
Issue/Submission Date
2022-11-14
2024-06-21
See all info for this product

See Less

USDMF

Found USDMF

34538
Active
SILODOSIN
2020-03-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Silodosin IHS at Unit-IV, Plot No. ...
2024-04-03
Application Number
34538
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
SILODOSIN
Silodosin IHS at Unit-IV, Plot No. ...
Issue/Submission Date
2020-03-03
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

35976
Active
TOFACITINIB CITRATE
2021-05-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0493
Valid
Tofacitinib Citrate IHS at Unit-IV,...
2024-04-03
Application Number
35976
Indian CDSCO WC-0493
Status
Active
Fees Unpaid
N/A
 
Valid
2027-01-21
Filing Details
TOFACITINIB CITRATE
Tofacitinib Citrate IHS at Unit-IV,...
Issue/Submission Date
2021-05-29
2024-04-03
See all info for this product

See Less

USDMF

Found USDMF

36964
Active
ZINC CHLORIDE USP
2022-03-31
CEP/COS

Found CEP/COS

CEP 2022-426 - Rev 01
Valid
Zinc chloride
2024-06-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36964
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
ZINC CHLORIDE USP
Zinc chloride
Issue/Submission Date
2022-03-31
2024-06-21
See all info for this product

See Less

USDMF

Found USDMF

34330
Active
ANTAZOLINE PHOSPHATE USP
2020-01-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
34330
Status
Active
Fees Unpaid
N/A
 
Filing Details
ANTAZOLINE PHOSPHATE USP
Issue/Submission Date
2020-01-01
See all info for this product

See Less

USDMF

Found USDMF

36965
Active
BILASTINE
2022-04-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36965
Status
Active
Fees Unpaid
N/A
 
Filing Details
BILASTINE
Issue/Submission Date
2022-04-30
See all info for this product

See Less

USDMF

Found USDMF

36959
Active
CHROMIC CHLORIDE HEXAHYDRATE USP
2022-06-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36959
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
CHROMIC CHLORIDE HEXAHYDRATE USP
Issue/Submission Date
2022-06-16
See all info for this product

See Less

USDMF

Found USDMF

36961
Active
CUPRIC CHLORIDE DIHYDRATE USP
2022-06-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36961
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
CUPRIC CHLORIDE DIHYDRATE USP
Issue/Submission Date
2022-06-04
See all info for this product

See Less

USDMF

Found USDMF

36608
Active
DAPAGLIFLOZIN (AMORPHOUS)
2022-02-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36608
Status
Active
Fees Unpaid
N/A
 
Filing Details
DAPAGLIFLOZIN (AMORPHOUS)
Issue/Submission Date
2022-02-10
See all info for this product

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USDMF

Found USDMF

37340
Active
ELOBIXIBAT HYDRATE
2022-10-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37340
Status
Active
Fees Unpaid
N/A
 
Filing Details
ELOBIXIBAT HYDRATE
Issue/Submission Date
2022-10-19
See all info for this product

See Less

USDMF

Found USDMF

35797
Active
FEBUXOSTAT FORM-A
2021-03-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35797
Status
Active
Fees Unpaid
N/A
 
Filing Details
FEBUXOSTAT FORM-A
Issue/Submission Date
2021-03-26
See all info for this product

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USDMF

Found USDMF

36107
Active
IMEGLIMIN HYDROCHLORIDE
2021-07-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36107
Status
Active
Fees Unpaid
N/A
 
Filing Details
IMEGLIMIN HYDROCHLORIDE
Issue/Submission Date
2021-07-20
See all info for this product

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USDMF

Found USDMF

36974
Active
ISAVUCONAZONIUM SULFATE
2022-05-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36974
Status
Active
Fees Unpaid
N/A
 
Filing Details
ISAVUCONAZONIUM SULFATE
Issue/Submission Date
2022-05-06
See all info for this product

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USDMF

Found USDMF

36114
Active
LOXOPROFEN SODIUM HYDRATE
2021-07-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36114
Status
Active
Fees Unpaid
N/A
 
Filing Details
LOXOPROFEN SODIUM HYDRATE
Issue/Submission Date
2021-07-31
See all info for this product

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USDMF

Found USDMF

36973
Active
MIRABEGRON
2022-04-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36973
Status
Active
Fees Unpaid
N/A
 
Filing Details
MIRABEGRON
Issue/Submission Date
2022-04-27
See all info for this product

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USDMF

Found USDMF

35516
Active
PANTOPRAZOLE MAGNESIUM
2021-03-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35516
Status
Active
Fees Unpaid
N/A
 
Filing Details
PANTOPRAZOLE MAGNESIUM
Issue/Submission Date
2021-03-25
See all info for this product

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USDMF

Found USDMF

36969
Active
POSACONAZOLE (FORM I)
2022-06-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36969
Status
Active
Fees Unpaid
N/A
 
Filing Details
POSACONAZOLE (FORM I)
Issue/Submission Date
2022-06-30
See all info for this product

See Less

USDMF

Found USDMF

37339
Active
RANOLAZINE
2022-08-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37339
Status
Active
Fees Unpaid
N/A
 
Filing Details
RANOLAZINE
Issue/Submission Date
2022-08-18
See all info for this product

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USDMF

Found USDMF

36958
Active
SELENIOUS ACID USP
2022-06-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36958
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
SELENIOUS ACID USP
Issue/Submission Date
2022-06-07
See all info for this product

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USDMF

Found USDMF

36132
Active
SILODOSIN BETA FORM
2021-07-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36132
Status
Active
Fees Unpaid
N/A
 
Filing Details
SILODOSIN BETA FORM
Issue/Submission Date
2021-07-28
See all info for this product

See Less

USDMF

Found USDMF

35515
Active
TEDIZOLID PHOSPHATE
2021-02-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35515
Status
Active
Fees Unpaid
N/A
 
Filing Details
TEDIZOLID PHOSPHATE
Issue/Submission Date
2021-02-20
See all info for this product

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USDMF

Found USDMF

35576
Active
TENELIGLIPTIN HYDROBROMIDE HYDRATE
2021-03-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35576
Status
Active
Fees Unpaid
N/A
 
Filing Details
TENELIGLIPTIN HYDROBROMIDE HYDRATE
Issue/Submission Date
2021-03-29
See all info for this product

See Less

USDMF

Found USDMF

35150
Active
VONOPRAZAN FUMARATE
2020-08-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35150
Status
Active
Fees Unpaid
N/A
 
Filing Details
VONOPRAZAN FUMARATE
Issue/Submission Date
2020-08-31
See all info for this product

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USDMF

Found USDMF

36963
Active
ZINC SULFATE HEPTAHYDRATE USP
2022-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36963
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
ZINC SULFATE HEPTAHYDRATE USP
Issue/Submission Date
2022-03-31
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