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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by GLAND PHARMA LIMITED

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    GLAND PHARMA LIMITED
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    6-3-865/1/2, Greenland Apartments Ameerpet, Hyderabad - 500016
    Telephone
    Telephone
    +91-40-66621010
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://glandpharma.com/
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    Atracurium Besylate

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    USDMF

    Found USDMF

    21189
    Active
    ATRACURIUM BESYLATE USP
    2007-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-272 - Rev 00
    Valid
    Atracurium besilate
    2015-12-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Atracurium Besylate USP
    2019-03-05
    Application Number
    21189
    R1-CEP 2008-272 - Rev 00
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-03-04
    Filing Details
    ATRACURIUM BESYLATE USP
    Atracurium besilate
    Atracurium Besylate USP
    Issue/Submission Date
    2007-12-03
    2015-12-18
    2019-03-05
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    Rocuronium Bromide

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    USDMF

    Found USDMF

    20833
    Active
    ROCURONIUM BROMIDE USP
    2007-09-05
    CEP/COS

    Caution CEP/COS

    R1-CEP 2008-033 - Rev 01
    Withdrawn by Holder
    Rocuronium bromide
    2015-09-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Rocuronium Bromide USP
    2022-08-04
    Application Number
    20833
    R1-CEP 2008-033 - Rev 01
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Valid
    2025-03-04
    Filing Details
    ROCURONIUM BROMIDE USP
    Rocuronium bromide
    Rocuronium Bromide USP
    Issue/Submission Date
    2007-09-05
    2015-09-29
    2022-08-04
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    Argatroban

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    USDMF

    Found USDMF

    25400
    Active
    ARGATROBAN MONOHYDRATE USP
    2011-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Argatroban Monohydrate USP
    2022-08-04
    Application Number
    25400
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    ARGATROBAN MONOHYDRATE USP
    Argatroban Monohydrate USP
    Issue/Submission Date
    2011-10-27
    2022-08-04
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    Betamethasone Acetate

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    USDMF

    Found USDMF

    30716
    Active
    BETAMETHASONE ACETATE USP STERILE
    2016-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Betamethasone 21-acetate USP
    2022-08-04
    Application Number
    30716
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-03-04
    Filing Details
    BETAMETHASONE ACETATE USP STERILE
    Betamethasone 21-acetate USP
    Issue/Submission Date
    2016-08-01
    2022-08-04
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    • FDA
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    Caspofungin

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    USDMF

    Found USDMF

    31893
    Active
    CASPOFUNGIN ACETATE
    2017-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Caspofungin Acetate IH
    2022-08-04
    Application Number
    31893
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-03-04
    Filing Details
    CASPOFUNGIN ACETATE
    Caspofungin Acetate IH
    Issue/Submission Date
    2017-07-21
    2022-08-04
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    • FDA
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    23232
    Active
    DEXMEDETOMIDINE HYDROCHLORIDE USP
    2009-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Dexmedetomidine HCL USP
    2022-08-04
    Application Number
    23232
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-03-04
    Filing Details
    DEXMEDETOMIDINE HYDROCHLORIDE USP
    Dexmedetomidine HCL USP
    Issue/Submission Date
    2009-10-30
    2022-08-04
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    Doxycycline Hyclate

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    USDMF

    Found USDMF

    33093
    Active
    DOXYCYCLINE HYCLATE USP
    2018-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Doxycycline Hyclate USP
    2022-08-04
    Application Number
    33093
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    DOXYCYCLINE HYCLATE USP
    Doxycycline Hyclate USP
    Issue/Submission Date
    2018-09-28
    2022-08-04
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    Foscarnet Sodium

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    USDMF

    Found USDMF

    29814
    Active
    FOSCARNET SODIUM USP
    2015-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Foscarnet sodium USP
    2022-08-04
    Application Number
    29814
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    FOSCARNET SODIUM USP
    Foscarnet sodium USP
    Issue/Submission Date
    2015-09-28
    2022-08-04
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    Fosphenytoin Sodium

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    USDMF

    Found USDMF

    33756
    Active
    FOSPHENYTOIN SODIUM
    2019-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Fosphenytoin Sodium USP
    2022-08-04
    Application Number
    33756
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    FOSPHENYTOIN SODIUM
    Fosphenytoin Sodium USP
    Issue/Submission Date
    2019-04-29
    2022-08-04
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    Glatiramer Acetate

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    USDMF

    Found USDMF

    33092
    Active
    GLATIRAMER ACETATE
    2018-09-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Glatiramer Acetate IH
    2022-08-04
    Application Number
    33092
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-03-04
    Filing Details
    GLATIRAMER ACETATE
    Glatiramer Acetate IH
    Issue/Submission Date
    2018-09-12
    2022-08-04
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    Indomethacin Sodium

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    USDMF

    Found USDMF

    25401
    Active
    INDOMETHACIN SODIUM USP
    2011-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Indomethacin Sodium USP
    2022-08-04
    Application Number
    25401
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-03-04
    Filing Details
    INDOMETHACIN SODIUM USP
    Indomethacin Sodium USP
    Issue/Submission Date
    2011-10-31
    2022-08-04
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    • FDA
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    Isoproterenol Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    33445
    Active
    ISOPROTERENOL HYDROCHLORIDE
    2019-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Isoproterenol Hydrochloride USP
    2022-08-04
    Application Number
    33445
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE
    Isoproterenol Hydrochloride USP
    Issue/Submission Date
    2019-02-28
    2022-08-04
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    • FDA
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    Levothyroxine Sodium

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    See Less

    USDMF

    Found USDMF

    29550
    Active
    LEVOTHYROXINE SODIUM USP
    2015-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Levothyroxine Sodium USP
    2022-08-04
    Application Number
    29550
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    LEVOTHYROXINE SODIUM USP
    Levothyroxine Sodium USP
    Issue/Submission Date
    2015-07-27
    2022-08-04
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    • FDA
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    Neostigmine Methylsulfate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32153
    Active
    NEOSTIGMINE METHYLSULFATE
    2017-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Neostigmine Methylsulfate USP
    2022-08-04
    Application Number
    32153
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    NEOSTIGMINE METHYLSULFATE
    Neostigmine Methylsulfate USP
    Issue/Submission Date
    2017-10-31
    2022-08-04
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    Paliperidone Palmitate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32041
    Active
    PALIPERIDONE PALMITATE STERILE
    2017-10-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    Paliperidone Palmitate (Sterile) IH
    2022-08-04
    Application Number
    32041
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    PALIPERIDONE PALMITATE STERILE
    Paliperidone Palmitate (Sterile) IH
    Issue/Submission Date
    2017-10-13
    2022-08-04
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    Plerixafor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31572
    Active
    PLERIXAFOR
    2017-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0427A3-4
    Valid
    PLERIXAFOR IH
    2022-08-04
    Application Number
    31572
    Indian CDSCO WC-0427A3-4
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    PLERIXAFOR
    PLERIXAFOR IH
    Issue/Submission Date
    2017-04-26
    2022-08-04
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    • EDQM
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    Bortezomib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26440
    Active
    BORTEZOMIB
    2012-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0353
    Expired
    Bortezomib IH
    2019-12-05
    Application Number
    26440
    Indian CDSCO WC-0353
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-01-18
    Filing Details
    BORTEZOMIB
    Bortezomib IH
    Issue/Submission Date
    2012-10-31
    2019-12-05
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    Cisatracurium Besylate

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    USDMF

    Found USDMF

    22962
    Active
    CISATRACURIUM BESYLATE
    2009-07-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Cis Atracurium Besylate IH
    2019-03-05
    Application Number
    22962
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-03-04
    Filing Details
    CISATRACURIUM BESYLATE
    Cis Atracurium Besylate IH
    Issue/Submission Date
    2009-07-21
    2019-03-05
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    Dalteparin sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25556
    Active
    DALTEPARIN SODIUM PH.EUR.
    2011-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0399
    Expired
    Dalteparin Sodium (Ph. Eur) (Low Mo...
    2017-07-05
    Application Number
    25556
    Indian CDSCO WC-0399
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2020-07-05
    Filing Details
    DALTEPARIN SODIUM PH.EUR.
    Dalteparin Sodium (Ph. Eur) (Low Mo...
    Issue/Submission Date
    2011-12-20
    2017-07-05
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    Dexmedetomidine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28608
    Active
    DEXMEDETOMIDINE HYDROCHLORIDE USP
    2014-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Dexmedetomidine HCL IH
    2019-03-05
    Application Number
    28608
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-03-04
    Filing Details
    DEXMEDETOMIDINE HYDROCHLORIDE USP
    Dexmedetomidine HCL IH
    Issue/Submission Date
    2014-10-31
    2019-03-05
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    Dexrazoxane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23172
    Active
    DEXRAZOXANE
    2009-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Dexrazoxane IH
    2019-03-05
    Application Number
    23172
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-03-04
    Filing Details
    DEXRAZOXANE
    Dexrazoxane IH
    Issue/Submission Date
    2009-09-22
    2019-03-05
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    Dexrazoxane

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    USDMF

    Found USDMF

    27826
    Active
    DEXRAZOXANE (PROCESS-II)
    2014-02-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0399
    Expired
    Dexrazoxane (IH)
    2017-07-05
    Application Number
    27826
    Indian CDSCO WC-0399
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2020-07-05
    Filing Details
    DEXRAZOXANE (PROCESS-II)
    Dexrazoxane (IH)
    Issue/Submission Date
    2014-02-04
    2017-07-05
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    Enoxaparin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2003-266 - Rev 03
    Valid
    Enoxaparin sodium
    2020-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0356
    Expired
    Enoxaparin Sodium Ph.Eur
    2020-02-10
    Application Number
    R1-CEP 2003-266 - Rev 03
    Indian CDSCO WC-0356
    Status
    Valid
     
    Expired
    2022-02-02
    Filing Details
    Enoxaparin sodium
    Enoxaparin Sodium Ph.Eur
    Issue/Submission Date
    2020-06-23
    2020-02-10
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    • EDQM
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    Gemcitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25938
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2012-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0353
    Expired
    Gemcitabine Hydrochloride USP/EP
    2019-12-05
    Application Number
    25938
    Indian CDSCO WC-0353
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-01-18
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine Hydrochloride USP/EP
    Issue/Submission Date
    2012-06-06
    2019-12-05
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    • FDA
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    Heparin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23839
    Active
    HEPARIN SODIUM USP
    2010-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0356
    Expired
    HEPARIN SODIUM EP
    2020-02-10
    Application Number
    23839
    Indian CDSCO WC-0356
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-02-02
    Filing Details
    HEPARIN SODIUM USP
    HEPARIN SODIUM EP
    Issue/Submission Date
    2010-04-19
    2020-02-10
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    • FDA
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    Iron Dextran

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27823
    Active
    IRON DEXTRAN COMPLEX
    2015-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0356
    Expired
    Iron Dextran IH
    2020-02-10
    Application Number
    27823
    Indian CDSCO WC-0356
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-02-02
    Filing Details
    IRON DEXTRAN COMPLEX
    Iron Dextran IH
    Issue/Submission Date
    2015-06-10
    2020-02-10
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    Iron Sucrose

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29637
    Active
    IRON SUCROSE COMPLEX
    2015-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0356
    Expired
    Iron Sucrose IH/Iron Sucrose liquid...
    2020-02-10
    Application Number
    29637
    Indian CDSCO WC-0356
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-02-02
    Filing Details
    IRON SUCROSE COMPLEX
    Iron Sucrose IH/Iron Sucrose liquid...
    Issue/Submission Date
    2015-08-31
    2020-02-10
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    • FDA
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    Regadenoson Monohydrate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27972
    Active
    REGADENOSON
    2014-02-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Regadenoson IH
    2019-03-05
    Application Number
    27972
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-03-04
    Filing Details
    REGADENOSON
    Regadenoson IH
    Issue/Submission Date
    2014-02-12
    2019-03-05
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    • EDQM
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    Rocuronium Bromide

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    26441
    Active
    ROCURONIUM BROMIDE USP
    2012-10-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0353
    Expired
    Rocuronium Bromide USP/EP
    2019-12-05
    Application Number
    26441
    Indian CDSCO WC-0353
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-01-18
    Filing Details
    ROCURONIUM BROMIDE USP
    Rocuronium Bromide USP/EP
    Issue/Submission Date
    2012-10-25
    2019-12-05
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    • FDA
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    Tigecycline

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

    See Less

    USDMF

    Found USDMF

    25935
    Active
    TIGECYCLINE USP
    2012-05-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Tigecycline IH
    2019-03-05
    Application Number
    25935
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-03-04
    Filing Details
    TIGECYCLINE USP
    Tigecycline IH
    Issue/Submission Date
    2012-05-19
    2019-03-05
    ASK
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    Tigecycline

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29788
    Active
    TIGECYCLINE [MANUFACTURING SITE - I...
    2015-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0399
    Expired
    Tigecycline (IH)
    2017-07-05
    Application Number
    29788
    Indian CDSCO WC-0399
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2020-07-05
    Filing Details
    TIGECYCLINE [MANUFACTURING SITE - I...
    Tigecycline (IH)
    Issue/Submission Date
    2015-09-30
    2017-07-05
    ASK
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    your Marketing & Sales content
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    • FDA
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    Ziprasidone Mesylate Trihydrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31028
    Active
    ZIPRASIDONE MESILATE TRIHYDRATE
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0427
    Expired
    Ziprasidone Mesylate Trihydrate EP
    2019-03-05
    Application Number
    31028
    Indian CDSCO WC-0427
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-03-04
    Filing Details
    ZIPRASIDONE MESILATE TRIHYDRATE
    Ziprasidone Mesylate Trihydrate EP
    Issue/Submission Date
    2016-09-30
    2019-03-05
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    • FDA
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    • WHO-GMP
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    Argatroban

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28030
    Active
    ARGATROBAN MONOHYDRATE (PROCESS-II)
    2014-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28030
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARGATROBAN MONOHYDRATE (PROCESS-II)
    Issue/Submission Date
    2014-05-15
    ASK
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    your Marketing & Sales content
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    • FDA
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    Atracurium Besylate

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

    See Less

    USDMF

    Found USDMF

    29636
    Active
    ATRACURIUM BESYLATE USP [PROCESS-II...
    2015-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29636
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ATRACURIUM BESYLATE USP [PROCESS-II...
    Issue/Submission Date
    2015-08-28
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    • FDA
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    Cisatracurium Besylate

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

    See Less

    USDMF

    Found USDMF

    29738
    Active
    CISATRACURIUM BESYLATE [PROCESS-II]
    2015-09-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29738
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CISATRACURIUM BESYLATE [PROCESS-II]
    Issue/Submission Date
    2015-09-24
    ASK
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    your Marketing & Sales content
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    • FDA
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    Cisatracurium Besylate

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

    See Less

    USDMF

    Found USDMF

    34425
    Active
    CISATRACRIUM BESYLATE
    2019-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34425
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CISATRACRIUM BESYLATE
    Issue/Submission Date
    2019-12-26
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Ertapenem Sodium

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

    See Less

    USDMF

    Found USDMF

    32424
    Active
    ERTAPENEM SODIUM
    2018-01-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32424
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERTAPENEM SODIUM
    Issue/Submission Date
    2018-01-12
    ASK
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    • FDA
    • EDQM
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    Erythromycin Lactobionate

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

    See Less

    USDMF

    Found USDMF

    34426
    Active
    ERYTHROMYCIN LACTOBIONATE
    2019-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34426
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERYTHROMYCIN LACTOBIONATE
    Issue/Submission Date
    2019-12-31
    ASK
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    your Marketing & Sales content
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    • FDA
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    Etomidate

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

    See Less

    USDMF

    Found USDMF

    34205
    Active
    ETOMIDATE
    2019-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34205
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ETOMIDATE
    Issue/Submission Date
    2019-09-30
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Fluphenazine Decanoate

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

    See Less

    USDMF

    Found USDMF

    33899
    Active
    FLUPHENAZINE DECANOATE
    2019-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33899
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLUPHENAZINE DECANOATE
    Issue/Submission Date
    2019-05-31
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Fulvestrant

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

    See Less

    USDMF

    Found USDMF

    29787
    Active
    FULVESTRANT USP
    2015-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29787
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FULVESTRANT USP
    Issue/Submission Date
    2015-09-28
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Indomethacin Sodium

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

    See Less

    USDMF

    Found USDMF

    27282
    Active
    INDOMETHACIN SODIUM USP
    2013-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27282
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    INDOMETHACIN SODIUM USP
    Issue/Submission Date
    2013-10-24
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Lacosamide

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

    See Less

    USDMF

    Found USDMF

    34784
    Active
    LACOSAMIDE
    2020-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34784
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LACOSAMIDE
    Issue/Submission Date
    2020-04-29
    ASK
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    • FDA
    • EDQM
    • WHO-GMP
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    Nicardipine Hydrochloride

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

    See Less

    USDMF

    Found USDMF

    29198
    Active
    NICARDIPINE HYDROCHLORIDE USP
    2015-04-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29198
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NICARDIPINE HYDROCHLORIDE USP
    Issue/Submission Date
    2015-04-28
    ASK
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    your Marketing & Sales content
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    • EDQM
    • WHO-GMP
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    Pemetrexed Disodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25399
    Active
    PEMETREXED DISODIUM 2.5 HYDRATE
    2011-11-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25399
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PEMETREXED DISODIUM 2.5 HYDRATE
    Issue/Submission Date
    2011-11-03
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
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    Sodium Phenylacetate

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

    See Less

    USDMF

    Found USDMF

    28424
    Active
    SODIUM PHENYLACETATE
    2014-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28424
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SODIUM PHENYLACETATE
    Issue/Submission Date
    2014-07-28
    ASK
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    • FDA
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    Sugammadex Sodium

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

    See Less

    USDMF

    Found USDMF

    34233
    Active
    SUGAMMADEX SODIUM
    2019-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34233
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM
    Issue/Submission Date
    2019-10-31
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
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    Tigecycline

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

    See Less

    USDMF

    Found USDMF

    34296
    Active
    TIGECYCLINE [PROCESS – II]
    2019-12-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34296
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TIGECYCLINE [PROCESS – II]
    Issue/Submission Date
    2019-12-04
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE

    Tirofiban

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

    See Less

    USDMF

    Found USDMF

    23173
    Active
    TIROFIBAN HYDROCHLORIDE
    2009-10-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23173
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TIROFIBAN HYDROCHLORIDE
    Issue/Submission Date
    2009-10-07
    ASK
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    your Marketing & Sales content
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    • FDA
    • EDQM
    • WHO-GMP
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE

    Zinc Sulfate Heptahydrate

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

    See Less

    USDMF

    Found USDMF

    34973
    Active
    ZINC SULFATE HEPTAHYDRATE
    2020-06-30
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    Application Number
    34973
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ZINC SULFATE HEPTAHYDRATE
    Issue/Submission Date
    2020-06-30
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