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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Glochem Industries

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    01 Amlodipine (1)

    02 Amlodipine Besylate (4)

    03 Amlodipine Maleate (1)

    04 Amlodipine Mesylate (1)

    05 CAS 144689-63-4 (1)

    06 Candesartan Cilexetil (1)

    07 Carbidopa (1)

    08 Cetirizine Dihydrochloride (2)

    09 Clopidogrel (2)

    10 Clopidogrel Besylate (1)

    11 Eprosartan Mesylate (1)

    12 Etilevodopa (1)

    13 Hydroxyzine Dihydrochloride (1)

    14 Levocetirizine Dihydrochloride (1)

    15 Raloxifene Hydrochloride (2)

    16 Telmisartan (2)

    17 Tolcapone (1)

    18 Topiramate (1)

    filter

    01 Active (11)

    02 Inactive (6)

    03 Blank (8)

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    01 Expired (1)

    02 Valid (6)

    03 Withdrawn by Holder (3)

    04 Blank (15)

    filter

    01 219MF10188 (1)

    02 302MF10027 (1)

    03 Blank (23)

    filter

    01 WC-0013 (3)

    02 WC-0029 (11)

    03 Blank (11)

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    Amlodipine Besylate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19591
    Active
    AMLODIPINE BESYLATE
    2006-07-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-173 - Rev 02
    Valid
    Amlodipine besilate, Process III
    2018-06-11
    Japanese DMF

    Found JDMF

    302MF10027
    Amlodipine Besilate (PI) at GV Cham...
    2020-02-06
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0013
    Expired
    Amlodipine Besylate EP/IP/USP/IH
    2019-09-11
    Application Number
    19591
    R1-CEP 2005-173 - Rev 02
    302MF10027
    Indian CDSCO WC-0013
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-10
    Filing Details
    AMLODIPINE BESYLATE
    Amlodipine besilate, Process III
    Amlodipine Besilate (PI) at GV Cham...
    Amlodipine Besylate EP/IP/USP/IH
    Issue/Submission Date
    2006-07-11
    2018-06-11
    2020-02-06
    2019-09-11
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    Amlodipine Besylate

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    USDMF

    Caution USDMF

    24942
    Inactive
    AMLODIPINE BESILATE
    2011-05-17
    CEP/COS

    Found CEP/COS

    CEP 2002-072 - Rev 10
    Valid
    Amlodipine besilate
    2023-10-06
    Japanese DMF

    Found JDMF

    219MF10188
    Amlodipine besylate at GV Chambers,...
    2007-06-08
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0029
    Expired
    Amlodipine Besilate (IP/USP/BP/Ph. ...
    2013-06-11
    Application Number
    24942
    CEP 2002-072 - Rev 10
    219MF10188
    Indian CDSCO WC-0029
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2016-06-05
    Filing Details
    AMLODIPINE BESILATE
    Amlodipine besilate
    Amlodipine besylate at GV Chambers,...
    Amlodipine Besilate (IP/USP/BP/Ph. ...
    Issue/Submission Date
    2011-05-17
    2023-10-06
    2007-06-08
    2013-06-11
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    19273
    Active
    CETIRIZINE DIHYDROCHLORIDE
    2006-01-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-171 - Rev 06
    Valid
    Cetirizine dihydrochloride
    2022-01-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0013
    Expired
    Cetrizine Dihydrochloride (Ph. Eur....
    2019-09-11
    Application Number
    19273
    R1-CEP 2003-171 - Rev 06
    Indian CDSCO WC-0013
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-10
    Filing Details
    CETIRIZINE DIHYDROCHLORIDE
    Cetirizine dihydrochloride
    Cetrizine Dihydrochloride (Ph. Eur....
    Issue/Submission Date
    2006-01-23
    2022-01-21
    2019-09-11
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    Raloxifene Hydrochloride

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    USDMF

    Found USDMF

    21682
    Active
    RALOXIFENE HYDROCHLORIDE
    2008-06-05
    CEP/COS

    Found CEP/COS

    CEP 2023-123 - Rev 00
    Valid
    Raloxifene hydrochloride, LAXAI
    2023-11-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0029
    Expired
    Raloxifene Hydrochloride EP/IH/USP
    2013-06-11
    Application Number
    21682
    CEP 2023-123 - Rev 00
    Indian CDSCO WC-0029
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2016-06-05
    Filing Details
    RALOXIFENE HYDROCHLORIDE
    Raloxifene hydrochloride, LAXAI
    Raloxifene Hydrochloride EP/IH/USP
    Issue/Submission Date
    2008-06-05
    2023-11-29
    2013-06-11
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    27810
    Active
    AMLODIPINE BESYLATE (PROCESS 1)
    2013-12-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-407 - Rev 00
    Valid
    Amlodipine besilate, Process-II
    2021-07-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27810
    R0-CEP 2020-407 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMLODIPINE BESYLATE (PROCESS 1)
    Amlodipine besilate, Process-II
    Issue/Submission Date
    2013-12-16
    2021-07-16
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    Carbidopa

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25563
    Active
    CARBIDOPA
    2011-12-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-338 - Rev 02
    Expired
    Carbidopa
    2015-05-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25563
    R0-CEP 2010-338 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    CARBIDOPA
    Carbidopa
    Issue/Submission Date
    2011-12-07
    2015-05-06
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    Cetirizine Dihydrochloride

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    USDMF

    Caution USDMF

    26467
    Inactive
    CETIRIZINE DIHYDROCHLORIDE
    2012-09-21
    CEP/COS

    Caution CEP/COS

    R1-CEP 2011-292 - Rev 00
    Withdrawn by Holder
    Cetirizine dihydrochloride, Unit II...
    2017-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0029
    Expired
    Cetrizine di HCl
    2013-06-11
    Application Number
    26467
    R1-CEP 2011-292 - Rev 00
    Indian CDSCO WC-0029
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2016-06-05
    Filing Details
    CETIRIZINE DIHYDROCHLORIDE
    Cetirizine dihydrochloride, Unit II...
    Cetrizine di HCl
    Issue/Submission Date
    2012-09-21
    2017-02-09
    2013-06-11
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    Levocetirizine Dihydrochloride

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    USDMF

    Found USDMF

    21110
    Active
    LEVOCETIRIZINE DIHYDROCHLORIDE USP
    2007-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0029
    Expired
    Levoceitrizine dihydrochloride IH/I...
    2013-06-11
    Application Number
    21110
    Indian CDSCO WC-0029
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2016-06-05
    Filing Details
    LEVOCETIRIZINE DIHYDROCHLORIDE USP
    Levoceitrizine dihydrochloride IH/I...
    Issue/Submission Date
    2007-12-06
    2013-06-11
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24362
    Inactive
    TELMISARTAN
    2010-11-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-271 - Rev 00
    Withdrawn by Holder
    Telmisartan
    2016-11-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0029
    Expired
    Telmisartan (IP/USP/BP/Ph. Eur.)
    2013-06-11
    Application Number
    24362
    R1-CEP 2010-271 - Rev 00
    Indian CDSCO WC-0029
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Expired
    2016-06-05
    Filing Details
    TELMISARTAN
    Telmisartan
    Telmisartan (IP/USP/BP/Ph. Eur.)
    Issue/Submission Date
    2010-11-11
    2016-11-04
    2013-06-11
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    Amlodipine

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    USDMF

    Found USDMF

    26543
    Active
    PHTHALIMIDO AMLODIPINE
    2012-10-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26543
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PHTHALIMIDO AMLODIPINE
    Issue/Submission Date
    2012-10-11
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