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    01 1Acetazolamide

    02 2Argatroban

    03 1Argatroban Monohydrate

    04 1Aripiprazole

    05 1Aripiprazole Lauroxil

    06 3Atracurium Besylate

    07 1Betamethasone Acetate

    08 1Bortezomib

    09 1Cangrelor

    10 1Caspofungin

    11 1Chlorothiazide

    12 4Cisatracurium Besylate

    13 1Copper Sulfate

    14 1Cysteamine Hydrochloride

    15 1Dalteparin sodium

    16 1Dantrolene Sodium

    17 2Dexmedetomidine Hydrochloride

    18 2Dexrazoxane

    19 1Diphenhydramine Hydrochloride

    20 1Doxycycline Hyclate

    21 1Edaravone

    22 1Enoxaparin Sodium

    23 2Epinephrine

    24 2Ertapenem

    25 1Erythromycin Lactobionate

    26 1Etomidate

    27 1Fluphenazine Decanoate

    28 1Fomepizole

    29 1Fosaprepitant

    30 1Foscarnet Sodium

    31 1Fosphenytoin Sodium

    32 2Fulvestrant

    33 1Gemcitabine

    34 1Glatiramer Acetate

    35 1Heparin Sodium

    36 1Imatinib Mesylate

    37 2Indomethacin Sodium

    38 1Iron Dextran

    39 1Iron Sucrose

    40 1Isavuconazonium Sulfate

    41 1Isoproterenol Hydrochloride

    42 1Ketamine Hydrochloride

    43 1Lacosamide

    44 1Levocarnitine

    45 1Linezolid

    46 1Manganese Sulfate

    47 1Meropenem

    48 1Metaraminol Bitartrate

    49 1Neostigmine Methylsulfate

    50 1Netarsudil Mesylate

    51 1Nicardipine Hydrochloride

    52 1Oxytocin

    53 1Paliperidone Palmitate

    54 1Pemetrexed Dipotassium

    55 1Pemetrexed Disodium

    56 1Plerixafor

    57 1Polymyxin B Sulfate

    58 1Pralatrexate

    59 1Procainamide Hydrochloride

    60 1Protamine Sulfate

    61 2Regadenoson Monohydrate

    62 3Rocuronium Bromide

    63 1Selenious Acid

    64 1Sodium Phenyl Acetate

    65 1Sodium Phenylacetate

    66 1Sugammadex Sodium

    67 1Sulfobutylether-β-Cydodextrin (SBECD)

    68 1Thyroxine

    69 3Tigecycline

    70 2Tirofiban

    71 1Zinc Sulfate Heptahydrate

    72 1Ziprasidone Mesylate

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    01

    Atracurium Besylate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Atracurium Besylate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21189

    Submission : 2007-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2008-272 - Rev 01

    Issue Date : 2024-11-28

    Type : Chemical

    Substance Number : 1970

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    02

    Rocuronium Bromide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Rocuronium Bromide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-07-10

    Pay. Date : 2024-07-08

    DMF Number : 20833

    Submission : 2007-09-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-174 - Rev 00

    Issue Date : 2025-12-15

    Type : Chemical

    Substance Number : 1764

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    03

    Betamethasone Acetate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Betamethasone Acetate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30716

    Submission : 2016-08-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Bortezomib

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Bortezomib

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-05-06

    Pay. Date : 2013-02-20

    DMF Number : 26440

    Submission : 2012-10-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-29

    Written Confirmation Number : WC-0353

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    05

    Caspofungin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Caspofungin

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31893

    Submission : 2017-07-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Dexmedetomidine Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Dexmedetomidine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23232

    Submission : 2009-10-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Fresenius Kabi Korea Co., Ltd.

    Registration Date : 2021-03-12

    Registration Number : Su181-5-ND

    Manufacturer Name : Gland Pharm Limited

    Manufacturer Address : Sy.No.143 to 148, 150 & 151, Near Gandimaisamma Cross Roads, DP Pally, Dundigal post, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad - 500 043, Telangana, India

     VMF Others AUDIT
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    07

    Dexrazoxane

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Dexrazoxane

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23172

    Submission : 2009-09-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Doxycycline Hyclate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Doxycycline Hyclate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-12-29

    Pay. Date : 2018-09-26

    DMF Number : 33093

    Submission : 2018-09-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Market
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    09

    Foscarnet Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Foscarnet Sodium

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-01-08

    Pay. Date : 2015-09-28

    DMF Number : 29814

    Submission : 2015-09-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    10

    Fosphenytoin Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Fosphenytoin Sodium

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-06-09

    Pay. Date : 2019-04-24

    DMF Number : 33756

    Submission : 2019-04-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-04-08

    Valid Till : 2025-04-03

    Written Confirmation Number : WC-0427

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Contact Gland Pharma Limited and get a quotation

    Gland Pharma Limited is a supplier offers 68 products (APIs, Excipients or Intermediates).

    Find Atracurium Besylate bulk with DMF, CEP offered by Gland Pharma Limited

    Find Rocuronium Bromide bulk with DMF, CEP offered by Gland Pharma Limited

    Find Betamethasone Acetate bulk with DMF offered by Gland Pharma Limited

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