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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by SMS Pharmaceuticals

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    SMS Pharmaceuticals
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    Country
    Country
    India
    Address
    Address
    Regd.off : Plot No:19-III, Road No:71, Jubilee Hills,Opp.Bharatiya Vidya Bhavan Public School, Hyderabad - 500034, Andhra Pradesh, India.
    Telephone
    Telephone
    91 - 40 - 6628 8888
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://smspharma.com/
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    Linkedin
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    • FDA
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    Famotidine

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    USDMF

    Found USDMF

    21442
    Active
    FAMOTIDINE USP
    2008-03-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-080 - Rev 03
    Valid
    Famotidine
    2019-09-16
    Japanese DMF

    Found JDMF

    226MF10116
    Famotidine JP (High Pure) at Plot N...
    2014-06-18
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Famotidine USP/EP/JP/IP
    2019-06-26
    Application Number
    21442
    R1-CEP 2009-080 - Rev 03
    226MF10116
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FAMOTIDINE USP
    Famotidine
    Famotidine JP (High Pure) at Plot N...
    Famotidine USP/EP/JP/IP
    Issue/Submission Date
    2008-03-20
    2019-09-16
    2014-06-18
    2019-06-26
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    Rizatriptan Benzoate

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    USDMF

    Found USDMF

    23066
    Active
    RIZATRIPTAN BENZOATE
    2009-08-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-028 - Rev 00
    Valid
    Rizatriptan benzoate
    2020-05-18
    Japanese DMF

    Found JDMF

    228MF10019
    Rizatriptan benzoate at Plot No. 72...
    2016-01-14
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    rizatrimptan benzoate USP/IP/EP
    2019-06-26
    Application Number
    23066
    R1-CEP 2013-028 - Rev 00
    228MF10019
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    RIZATRIPTAN BENZOATE
    Rizatriptan benzoate
    Rizatriptan benzoate at Plot No. 72...
    rizatrimptan benzoate USP/IP/EP
    Issue/Submission Date
    2009-08-26
    2020-05-18
    2016-01-14
    2019-06-26
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    • FDA
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    Tadalafil

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    USDMF

    Found USDMF

    24206
    Active
    TADALAFIL
    2010-09-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-308 - Rev 00
    Valid
    Tadalafil
    2021-03-29
    Japanese DMF

    Found JDMF

    231MF10041
    Tadalafil at Plot No. 72, H. No.8-2...
    2019-02-13
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Tadalafil (USP/EP/IH)
    2019-06-26
    Application Number
    24206
    R1-CEP 2014-308 - Rev 00
    231MF10041
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    TADALAFIL
    Tadalafil
    Tadalafil at Plot No. 72, H. No.8-2...
    Tadalafil (USP/EP/IH)
    Issue/Submission Date
    2010-09-28
    2021-03-29
    2019-02-13
    2019-06-26
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    • FDA
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    Lamotrigine

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    USDMF

    Found USDMF

    34290
    Active
    LAMOTRIGINE USP
    2019-11-20
    CEP/COS

    Found CEP/COS

    CEP 2020-222 - Rev 01
    Valid
    Lamotrigine
    2023-11-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Lamotrigine USP/EP
    2022-07-08
    Application Number
    34290
    CEP 2020-222 - Rev 01
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    LAMOTRIGINE USP
    Lamotrigine
    Lamotrigine USP/EP
    Issue/Submission Date
    2019-11-20
    2023-11-27
    2022-07-08
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    Levetiracetam

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    USDMF

    Found USDMF

    28431
    Active
    LEVETIRACETAM USP
    2014-06-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-275 - Rev 00
    Valid
    Levetiracetam
    2020-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Levetiracetam USP/EP
    2022-07-08
    Application Number
    28431
    R1-CEP 2014-275 - Rev 00
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-21
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam
    Levetiracetam USP/EP
    Issue/Submission Date
    2014-06-30
    2020-12-09
    2022-07-08
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    Sumatriptan

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    USDMF

    Caution USDMF

    16279
    Inactive
    SUMATRIPTAN SUCCINATE
    2002-12-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-329 - Rev 05
    Valid
    Sumatriptan succinate, Alternative ...
    2019-09-16
    Japanese DMF

    Found JDMF

    228MF10195
    Sumatriptan succinate at Plot No. 7...
    2016-10-11
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Sumatriptan Succinate USP/EP/BP/IP/...
    2019-06-26
    Application Number
    16279
    R1-CEP 2007-329 - Rev 05
    228MF10195
    Indian CDSCO WC-0071
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    SUMATRIPTAN SUCCINATE
    Sumatriptan succinate, Alternative ...
    Sumatriptan succinate at Plot No. 7...
    Sumatriptan Succinate USP/EP/BP/IP/...
    Issue/Submission Date
    2002-12-02
    2019-09-16
    2016-10-11
    2019-06-26
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    • FDA
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    Vardenafil Hydrochloride

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    USDMF

    Found USDMF

    32908
    Active
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE...
    2018-09-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-202 - Rev 00
    Valid
    Vardenafil hydrochloride trihydrate
    2020-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Vardenafil Hydrochloride USP/EP
    2022-07-08
    Application Number
    32908
    R0-CEP 2018-202 - Rev 00
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    VARDENAFIL HYDROCHLORIDE TRIHYDRATE...
    Vardenafil hydrochloride trihydrate
    Vardenafil Hydrochloride USP/EP
    Issue/Submission Date
    2018-09-20
    2020-05-14
    2022-07-08
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    Itraconazole

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    USDMF

    Found USDMF

    25514
    Active
    ITRACONAZOLE USP
    2011-11-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-403 - Rev 01
    Valid
    Itraconazole, Bachupally site
    2019-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Itraconazolum USP/EP/JP/IP
    2019-06-26
    Application Number
    25514
    R1-CEP 2012-403 - Rev 01
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ITRACONAZOLE USP
    Itraconazole, Bachupally site
    Itraconazolum USP/EP/JP/IP
    Issue/Submission Date
    2011-11-22
    2019-09-16
    2019-06-26
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    22340
    Active
    ONDANSETRON HYDROCHLORIDE USP
    2008-12-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-319 - Rev 04
    Valid
    Ondansetron hydrochloride dihydrate
    2019-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Ondansetron HCl Dihydrate USP/EP/J...
    2019-06-26
    Application Number
    22340
    R1-CEP 2009-319 - Rev 04
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ONDANSETRON HYDROCHLORIDE USP
    Ondansetron hydrochloride dihydrate
    Ondansetron HCl Dihydrate USP/EP/J...
    Issue/Submission Date
    2008-12-23
    2019-09-16
    2019-06-26
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    Pantoprazole Sodium

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    USDMF

    Caution USDMF

    22161
    Inactive
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    2008-11-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-088 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate, ...
    2021-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Pantoprazole Sodium Sesquihydrate E...
    2022-07-08
    Application Number
    22161
    R1-CEP 2015-088 - Rev 00
    Indian CDSCO WC-0373
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    PANTOPRAZOLE SODIUM SESQUIHYDRATE
    Pantoprazole sodium sesquihydrate, ...
    Pantoprazole Sodium Sesquihydrate E...
    Issue/Submission Date
    2008-11-10
    2021-07-20
    2022-07-08
    ASK
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    Ranitidine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17542
    Inactive
    RANITIDINE HYDROCHLORIDE
    2004-07-13
    CEP/COS

    Found CEP/COS

    CEP 2017-068 - Rev 03
    Valid
    Ranitidine hydrochloride
    2024-03-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Ranitidine Hydrochloride USP/EP
    2022-07-08
    Application Number
    17542
    CEP 2017-068 - Rev 03
    Indian CDSCO WC-0373
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-21
    Filing Details
    RANITIDINE HYDROCHLORIDE
    Ranitidine hydrochloride
    Ranitidine Hydrochloride USP/EP
    Issue/Submission Date
    2004-07-13
    2024-03-13
    2022-07-08
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    • FDA
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33520
    Active
    APIXABAN
    2019-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Apixaban IH
    2022-07-08
    Application Number
    33520
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2019-01-31
    2022-07-08
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    Efavirenz

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34356
    Active
    EFAVIRENZ USP
    2021-03-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    EFAVERINZ EP
    2022-07-08
    Application Number
    34356
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    EFAVIRENZ USP
    EFAVERINZ EP
    Issue/Submission Date
    2021-03-17
    2022-07-08
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    • FDA
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    Famotidine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-480 - Rev 00
    Valid
    Famotidine, Unit-VII
    2023-04-04
    Japanese DMF

    Found JDMF

    223MF10139
    Famotidine at Plot No. 72, H. No.8-...
    2011-08-30
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-480 - Rev 00
    223MF10139
    Status
    Valid
     
    Filing Details
    Famotidine, Unit-VII
    Famotidine at Plot No. 72, H. No.8-...
    Issue/Submission Date
    2023-04-04
    2011-08-30
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    • FDA
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35215
    Active
    IBUPROFEN USP
    2020-09-30
    CEP/COS

    Found CEP/COS

    CEP 2020-414 - Rev 01
    Valid
    Ibuprofen, IPA route
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35215
    CEP 2020-414 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IBUPROFEN USP
    Ibuprofen, IPA route
    Issue/Submission Date
    2020-09-30
    2024-03-25
    ASK
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29129
    Active
    PANTOPRAZOLE SODIUM USP
    2015-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-262 - Rev 00
    Valid
    Pantoprazole sodium sesquihydrate
    2016-03-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29129
    R1-CEP 2008-262 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PANTOPRAZOLE SODIUM USP
    Pantoprazole sodium sesquihydrate
    Issue/Submission Date
    2015-03-04
    2016-03-11
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    Sildenafil Citrate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21250
    Inactive
    Sildenafil Citrate
    2008-01-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-060 - Rev 00
    Valid
    Sildenafil citrate
    2020-01-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Sildenafil Citrate USP/Ph.Eur./IH/I...
    2019-06-26
    Application Number
    21250
    R1-CEP 2013-060 - Rev 00
    Indian CDSCO WC-0071
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Sildenafil Citrate
    Sildenafil citrate
    Sildenafil Citrate USP/Ph.Eur./IH/I...
    Issue/Submission Date
    2008-01-22
    2020-01-14
    2019-06-26
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    Solifenacin Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36133
    Active
    SOLIFENACIN SUCCINATE
    2022-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Solifenacin Succinate IH
    2022-07-08
    Application Number
    36133
    Indian CDSCO WC-0373
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    SOLIFENACIN SUCCINATE
    Solifenacin Succinate IH
    Issue/Submission Date
    2022-07-15
    2022-07-08
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    Almotriptan Malate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18962
    Active
    ALMOTRIPTAN MALATE
    2005-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Almotriptan maleate IH
    2019-06-26
    Application Number
    18962
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ALMOTRIPTAN MALATE
    Almotriptan maleate IH
    Issue/Submission Date
    2005-11-18
    2019-06-26
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    Aripiprazole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    22339
    Inactive
    ARIPIPRAZOLE
    2008-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Aripiprazole Depot USP/EP
    2022-07-08
    Application Number
    22339
    Indian CDSCO WC-0373
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    ARIPIPRAZOLE
    Aripiprazole Depot USP/EP
    Issue/Submission Date
    2008-12-23
    2022-07-08
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    Imidapril Hydrochloride

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    USDMF

    Found USDMF

    22705
    Active
    IMIDAPRIL HYDROCHLORIDE
    2009-04-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Imidapril Hydrochloride IH
    2019-06-26
    Application Number
    22705
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    IMIDAPRIL HYDROCHLORIDE
    Imidapril Hydrochloride IH
    Issue/Submission Date
    2009-04-07
    2019-06-26
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    Rosiglitazone Maleate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    22404
    Inactive
    ROSIGLITAZONE MALEATE
    2009-01-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Rosiglitazone Maleate USP
    2022-07-08
    Application Number
    22404
    Indian CDSCO WC-0373
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-21
    Filing Details
    ROSIGLITAZONE MALEATE
    Rosiglitazone Maleate USP
    Issue/Submission Date
    2009-01-16
    2022-07-08
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    Zolmitriptan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20110
    Active
    ZOLMITRIPTAN
    2007-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0071
    Expired
    Zolmitriptan USP/IH
    2019-06-26
    Application Number
    20110
    Indian CDSCO WC-0071
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ZOLMITRIPTAN
    Zolmitriptan USP/IH
    Issue/Submission Date
    2007-01-04
    2019-06-26
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    Aripiprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29991
    Active
    ARIPIPRAZOLE USP
    2015-11-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29991
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE USP
    Issue/Submission Date
    2015-11-04
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    Eletriptan Hydrobromide Monohydrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24905
    Active
    ELETRIPTAN HYDROBROMIDE MONOHYDRATE
    2011-05-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24905
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ELETRIPTAN HYDROBROMIDE MONOHYDRATE
    Issue/Submission Date
    2011-05-02
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    Hydroxychloroquine Sulphate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37131
    Active
    HYDROXYCHLOROQUINE SULFATE USP
    2022-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37131
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROXYCHLOROQUINE SULFATE USP
    Issue/Submission Date
    2022-05-19
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    • FDA
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    Ibuprofen

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-056 - Rev 00
    Valid
    Ibuprofen, Hexanes route
    2022-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-056 - Rev 00
    Status
    Valid
     
    Filing Details
    Ibuprofen, Hexanes route
    Issue/Submission Date
    2022-07-21
    ASK
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    • FDA
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    Lamivudine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34310
    Active
    LAMIVUDINE USP
    2019-11-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34310
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LAMIVUDINE USP
    Issue/Submission Date
    2019-11-26
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    Lanoconazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10035
    LANOCONAZOLE at Plot No. 19-III, Ro...
    2009-02-09
    Written Confirmation

    Close WC

    Application Number
    221MF10035
    Status
     
    Filing Details
    LANOCONAZOLE at Plot No. 19-III, Ro...
    Issue/Submission Date
    2009-02-09
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    Lanoconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10073
    LANOCONAZOLE at Plot No. 72, H. No....
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    227MF10073
    Status
     
    Filing Details
    LANOCONAZOLE at Plot No. 72, H. No....
    Issue/Submission Date
    2015-03-12
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    • FDA
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    Lopinavir

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Lopinavir
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Lopinavir
    Issue/Submission Date
    2022-07-08
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    • FDA
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    Luliconazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Luliconazole (Normal Grade) IH
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Luliconazole (Normal Grade) IH
    Issue/Submission Date
    2022-07-08
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    • FDA
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    Molnupiravir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36770
    Active
    MOLNUPIRAVIR
    2022-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36770
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MOLNUPIRAVIR
    Issue/Submission Date
    2022-07-15
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    Paliperidone Palmitate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Paliperidone Palmitate IH
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Paliperidone Palmitate IH
    Issue/Submission Date
    2022-07-08
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    • FDA
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    Penciclovir

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Penciclovir IHS
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Penciclovir IHS
    Issue/Submission Date
    2022-07-08
    ASK
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    Penciclovir Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29724
    Active
    PENCICLOVIR
    2015-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29724
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PENCICLOVIR
    Issue/Submission Date
    2015-09-02
    ASK
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    • FDA
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    Pirfenidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37925
    Active
    PIRFENIDONE
    2022-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37925
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIRFENIDONE
    Issue/Submission Date
    2022-12-31
    ASK
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    • FDA
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    Ramipril

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    17401
    Inactive
    RAMIPRIL
    2004-05-20
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-194 - Rev 02
    Withdrawn by Holder
    Ramipril
    2018-04-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17401
    R1-CEP 2004-194 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    RAMIPRIL
    Ramipril
    Issue/Submission Date
    2004-05-20
    2018-04-26
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    • FDA
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    Ranitidine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31575
    Active
    RANITIDINE HYDROCHLORIDE USP (PROCE...
    2017-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31575
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RANITIDINE HYDROCHLORIDE USP (PROCE...
    Issue/Submission Date
    2017-03-16
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    Ranitidine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Caution USDMF

    18129
    Inactive
    RANITIDINE HYDROCHLORIDE USP
    2005-03-03
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-171 - Rev 01
    Withdrawn by Holder
    Ranitidine hydrochloride
    2011-07-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18129
    R1-CEP 2004-171 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    RANITIDINE HYDROCHLORIDE USP
    Ranitidine hydrochloride
    Issue/Submission Date
    2005-03-03
    2011-07-25
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    Ranitidine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    25608
    Inactive
    RANITIDINE HYDROCHLORIDE USP (UNIT-...
    2011-12-22
    CEP/COS

    Caution CEP/COS

    R0-CEP 2005-058 - Rev 00
    Expired
    Ranitidine hydrochloride, Form 1
    2009-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25608
    R0-CEP 2005-058 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Expired
     
    Filing Details
    RANITIDINE HYDROCHLORIDE USP (UNIT-...
    Ranitidine hydrochloride, Form 1
    Issue/Submission Date
    2011-12-22
    2009-02-12
    ASK
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    • FDA
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    Ranolazine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Ranolazine IH
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Ranolazine IH
    Issue/Submission Date
    2022-07-08
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    34212
    Active
    RIVAROXABAN
    2020-06-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34212
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVAROXABAN
    Issue/Submission Date
    2020-06-27
    ASK
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    • FDA
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    Rosiglitazone Maleate

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    29386
    Active
    ROSIGLITAZONE MALEATE USP
    2015-05-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29386
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ROSIGLITAZONE MALEATE USP
    Issue/Submission Date
    2015-05-14
    ASK
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    • FDA
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    Sildenafil Citrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25358
    Active
    SILDENAFIL CITRATE (UNIT-II)
    2011-08-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25358
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SILDENAFIL CITRATE (UNIT-II)
    Issue/Submission Date
    2011-08-18
    ASK
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    • FDA
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    Sitagliptin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0373
    Valid
    Sitagliptin Hydrochloride IH
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Sitagliptin Hydrochloride IH
    Issue/Submission Date
    2022-07-08
    ASK
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    your Marketing & Sales content
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    • FDA
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    Sumatriptan

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20746
    Active
    SUMATRIPTAN SUCCINATE (ALTERNATIVE ...
    2007-08-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20746
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUMATRIPTAN SUCCINATE (ALTERNATIVE ...
    Issue/Submission Date
    2007-08-03
    ASK
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    • FDA
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    Sumatriptan

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    20906
    Active
    SUMATRIPTAN USP (ALTERNATIVE SYNTHE...
    2007-10-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20906
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUMATRIPTAN USP (ALTERNATIVE SYNTHE...
    Issue/Submission Date
    2007-10-03
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    USDMF

    Caution USDMF

    18287
    Inactive
    SUMATRIPTAN USP
    2005-04-19
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-175 - Rev 04
    Withdrawn by Holder
    Sumatriptan succinate
    2019-09-16
    Japanese DMF

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    Application Number
    18287
    R1-CEP 2004-175 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SUMATRIPTAN USP
    Sumatriptan succinate
    Issue/Submission Date
    2005-04-19
    2019-09-16
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    Tenofovir Disoproxil Fumarate

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    Indian CDSCO WC-0373
    Valid
    Tenofovir Disoproxil Fumarate IH
    2022-07-08
    Application Number
    Indian CDSCO WC-0373
    Status
     
    Valid
    2025-07-21
    Filing Details
    Tenofovir Disoproxil Fumarate IH
    Issue/Submission Date
    2022-07-08
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