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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Gland Pharma Limited to the U.S. FDA. Original Data : FDA Website

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    GLAND PHARMA LIMITED

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    APIs // Active Pharmaceutical Ingredients

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    01 ACETAZOLAMIDE (1)

    02 ARGATROBAN MONOHYDRATE (PROCESS-II) (1)

    03 ARGATROBAN MONOHYDRATE USP (1)

    04 ARIPIPRAZOLE LAUROXIL – STERILE (1)

    05 ARIPIPRAZOLE MONOHYDRATE – STERILE (1)

    06 ATRACURIUM BESYLATE USP (1)

    07 ATRACURIUM BESYLATE USP [PROCESS-II] (1)

    08 BETAMETHASONE ACETATE USP STERILE (1)

    09 BORTEZOMIB (1)

    10 CASPOFUNGIN ACETATE (1)

    11 CHLOROTHIAZIDE (1)

    12 CISATRACRIUM BESYLATE (1)

    13 CISATRACURIUM BESYLATE (1)

    14 CISATRACURIUM BESYLATE [PROCESS-II] (1)

    15 CUPRIC SULFATE (1)

    16 CYSTEAMINE HYDROCHLORIDE (1)

    17 DALTEPARIN SODIUM PH.EUR. (1)

    18 DEXMEDETOMIDINE HYDROCHLORIDE USP (2)

    19 DEXRAZOXANE (1)

    20 DEXRAZOXANE (PROCESS-II) (1)

    21 DIPHENHYDRAMINE HYDROCHLORIDE (1)

    22 DOXYCYCLINE HYCLATE USP (1)

    23 EDARAVONE (1)

    24 EPINEPHRINE (1)

    25 EPINEPHRINE (LOW EPIMER) (1)

    26 ERTAPENEM SODIUM (1)

    27 ERYTHROMYCIN LACTOBIONATE (1)

    28 ETOMIDATE (1)

    29 FLUPHENAZINE DECANOATE (1)

    30 FOMEPIZOLE (1)

    31 FOSAPREPITANT DIMEGLUMINE (1)

    32 FOSCARNET SODIUM USP (1)

    33 FOSPHENYTOIN SODIUM (1)

    34 FULVESTRANT USP (1)

    35 GEMCITABINE HYDROCHLORIDE USP (1)

    36 GLATIRAMER ACETATE (1)

    37 HEPARIN SODIUM USP (1)

    38 INDOMETHACIN SODIUM USP (2)

    39 IRON DEXTRAN COMPLEX (1)

    40 IRON SUCROSE COMPLEX (1)

    41 ISOPROTERENOL HYDROCHLORIDE (1)

    42 KETAMINE HYDROCHLORIDE (1)

    43 LACOSAMIDE (1)

    44 LEVOCARNITINE (1)

    45 LEVOTHYROXINE SODIUM USP (1)

    46 LINEZOLID (1)

    47 MANGANESE SULFATE (1)

    48 NEOSTIGMINE METHYLSULFATE (1)

    49 NETARSUDIL DIMESYLATE (1)

    50 NICARDIPINE HYDROCHLORIDE USP (1)

    51 PALIPERIDONE PALMITATE STERILE (1)

    52 PEMETREXED DISODIUM 2.5 HYDRATE (1)

    53 PLERIXAFOR (1)

    54 PROCAINAMIDE HYDROCHLORIDE (1)

    55 PROTAMINE SULFATE (1)

    56 REGADENOSON (1)

    57 REGADENOSON (PROCESS – II) (1)

    58 ROCURONIUM BROMIDE USP (2)

    59 SELENIOUS ACID (1)

    60 SODIUM PHENYLACETATE (1)

    61 SUGAMMADEX SODIUM (1)

    62 TIGECYCLINE USP (1)

    63 TIGECYCLINE [MANUFACTURING SITE - II] (1)

    64 TIGECYCLINE [PROCESS – II] (1)

    65 TIROFIBAN HYDROCHLORIDE (1)

    66 ZINC SULFATE HEPTAHYDRATE (1)

    67 ZIPRASIDONE MESILATE TRIHYDRATE (1)

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    01 GLAND CHEMICALS PRIVATE LTD (4)

    02 GLAND PHARMA LTD (66)

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    01 Active (70)

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    01 Complete (53)

    02 Blank (17)

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    ACETAZOLAMIDE

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    GLAND PHARMA LTD
    Active
    37616
    Complete
    2023-03-15
    2023-02-09
    2022-10-31
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    ARGATROBAN MONOHYDRATE (PROCESS-II)

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    GLAND PHARMA LTD
    Active
    28030
    Complete
    2014-12-15
    2014-11-28
    2014-05-15
    II
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    ARGATROBAN MONOHYDRATE USP

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    GLAND PHARMA LTD
    Active
    25400
    Complete
    2013-07-12
    2013-03-26
    2011-10-27
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    ARIPIPRAZOLE LAUROXIL – STERILE

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    GLAND PHARMA LTD
    Active
    36522
    Complete
    2022-03-31
    2021-12-14
    2021-12-22
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    ARIPIPRAZOLE MONOHYDRATE – STERIL...

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    GLAND PHARMA LTD
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    36260
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    2021-11-18
    2021-09-24
    2021-09-30
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    ATRACURIUM BESYLATE USP

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    GLAND PHARMA LTD
    Active
    21189
    N/A
    2007-12-03
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    ATRACURIUM BESYLATE USP [PROCESS-II...

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    GLAND PHARMA LTD
    Active
    29636
    N/A
    2015-08-28
    II
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    BETAMETHASONE ACETATE USP STERILE

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    GLAND PHARMA LTD
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    30716
    N/A
    2016-08-01
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    BORTEZOMIB

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    GLAND CHEMICALS PRIVA...
    Active
    26440
    Complete
    2013-05-06
    2013-02-20
    2012-10-31
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    CASPOFUNGIN ACETATE

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    GLAND PHARMA LTD
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    31893
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    2017-07-21
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