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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Gland Pharma Limited

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    01 Acetazolamide (1)

    02 Argatroban (2)

    03 Argatroban Monohydrate (1)

    04 Aripiprazole (1)

    05 Aripiprazole Lauroxil (1)

    06 Atracurium Besylate (2)

    07 Betamethasone Acetate (1)

    08 Bortezomib (1)

    09 Cangrelor (1)

    10 Caspofungin (1)

    11 Chlorothiazide (1)

    12 Cisatracurium Besylate (3)

    13 Copper Sulfate (1)

    14 Cysteamine Hydrochloride (1)

    15 Dalteparin sodium (1)

    16 Dexmedetomidine Hydrochloride (3)

    17 Dexrazoxane (2)

    18 Diphenhydramine Hydrochloride (1)

    19 Doxycycline Hyclate (1)

    20 Edaravone (1)

    21 Enoxaparin Sodium (1)

    22 Epinephrine (1)

    23 Ertapenem Sodium (1)

    24 Erythromycin Lactobionate (1)

    25 Etomidate (1)

    26 Fluphenazine Decanoate (1)

    27 Fomepizole (1)

    28 Fosaprepitant (1)

    29 Foscarnet Sodium (1)

    30 Fosphenytoin Sodium (1)

    31 Fulvestrant (1)

    32 Gemcitabine (1)

    33 Glatiramer Acetate (1)

    34 Heparin Sodium (1)

    35 Indomethacin Sodium (2)

    36 Iron Dextran (1)

    37 Iron Sucrose (1)

    38 Isavuconazonium Sulfate (1)

    39 Isoproterenol Hydrochloride (1)

    40 Ketamine Hydrochloride (1)

    41 Lacosamide (1)

    42 Levocarnitine (1)

    43 Levothyroxine Sodium (1)

    44 Linezolid (1)

    45 Manganese Sulfate (1)

    46 Metaraminol Bitartrate (1)

    47 Neostigmine Methylsulfate (1)

    48 Netarsudil Mesylate (1)

    49 Nicardipine Hydrochloride (1)

    50 Oxytocin (1)

    51 Paliperidone Palmitate (1)

    52 Pemetrexed Disodium (1)

    53 Plerixafor (1)

    54 Polymyxin B Sulfate (1)

    55 Procainamide Hydrochloride (1)

    56 Protamine Sulfate (1)

    57 Regadenoson Monohydrate (2)

    58 Rocuronium Bromide (2)

    59 Selenious Acid (1)

    60 Sodium Phenyl Acetate (1)

    61 Sodium Phenylacetate (1)

    62 Sugammadex Sodium (1)

    63 Sulfobutylether-β-Cydodextrin (SBECD) (1)

    64 Tigecycline (3)

    65 Tirofiban (1)

    66 Zinc Sulfate Heptahydrate (1)

    67 Ziprasidone Mesylate Trihydrate (1)

    68 Blank (1)

    filter

    01 Active (70)

    02 Blank (10)

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    01 Valid (2)

    02 Withdrawn by Holder (1)

    03 Blank (77)

    filter

    01 Blank (80)

    filter

    01 WC-0353 (3)

    02 WC-0356 (4)

    03 WC-0399 (4)

    04 WC-0427 (8)

    05 WC-0427A3-4 (16)

    06 Blank (45)

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    Atracurium Besylate

    PDF Supplier PDF
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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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    Caspofungin

    PDF Supplier PDF
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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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    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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