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    01 1Acebrophylline

    02 1Acyclovir

    03 1Albendazole

    04 1Alogliptin Benzoate

    05 1Ambroxol Hydrochloride

    06 1Amiodarone Hydrochloride

    07 1Armodafinil

    08 1Articaine Hydrochloride

    09 1Benazepril Hydrochloride

    10 1Benfotiamine

    11 1Benserazide Hydrochloride

    12 1Benzocaine

    13 1Biapenem

    14 1Biperiden Hydrochloride

    15 1Bupivacaine Hydrochloride

    16 1Buspirone Hydrochloride

    17 1Calcium Polystyrene Sulfonate

    18 1Canagliflozin

    19 1Cilastatin Sodium

    20 1Cinchocaine Hydrochloride

    21 1Clotrimazole

    22 1Dapagliflozin

    23 1Deferasirox

    24 1Dexketoprofen Trometamol

    25 2Doripenem

    26 1Dronedarone Hydrochloride

    27 1Drotaverine

    28 1Efinaconazole

    29 1Empagliflozin

    30 1Enoxaparin Sodium

    31 1Eravacycline

    32 1Ertapenem

    33 1Esomeprazole Sodium

    34 1Etodolac

    35 1Etoricoxib

    36 1Faropenem

    37 1Febuxostat

    38 1Ferric Carboxymaltose

    39 3Flecainide

    40 1Fondaparinux Sodium

    41 1Fosaprepitant

    42 1Fosfomycin Trometamol

    43 1Fosravuconazole

    44 1Fulvestrant

    45 2Ganciclovir

    46 1Heparin Sodium

    47 1Hydrochlorothiazide

    48 3Imipenem

    49 1Imipenem-Cilastatin Sodium

    50 1Ipragliflozin

    51 1Isavuconazonium Sulfate

    52 1Lacosamide

    53 1Lamotrigine

    54 1Lanthanum Carbonate

    55 1Lenapenem

    56 1Lercanidipine

    57 1Leuprolide Acetate

    58 1Levobupivacaine

    59 1Levosimendan

    60 1Lidocaine Hydrochloride

    61 1Linagliptin

    62 1Linezolid

    63 1Liraglutide

    64 2Lisinopril

    65 1Luliconazole

    66 1Lymecycline

    67 1Mebeverine

    68 1Meloxicam

    69 1Mepivacaine Hydrochloride

    70 3Meropenem

    71 1Minocycline Hydrochloride

    72 1Minoxidil

    73 2Montelukast Sodium

    74 1Moxifloxacin Hydrochloride

    75 1Nalidixic Acid

    76 1Nebivolol

    77 1Nimesulide

    78 5Nitrofurantoin

    79 1Obeticholic Acid

    80 1Octreotide Acetate

    81 1Olopatadine Hydrochloride

    82 1Omadacycline

    83 1Oteseconazole

    84 1Paliperidone

    85 1Panipenem

    86 1Pimozide

    87 1Posaconazole

    88 1Prilocaine

    89 1Prilocaine Hydrochloride

    90 1Procaine

    91 1Propofol

    92 1Racecadotril

    93 1Ramipril

    94 1Rifaximin

    95 1Risedronate Sodium

    96 1Rivaroxaban

    97 1Rizatriptan Benzoate

    98 1Ropivacaine Hydrochloride

    99 1Sarecycline

    100 1Sevelamer Carbonate

    101 1Sevelamer Hydrochloride

    102 1Silodosin

    103 2Solifenacin Succinate

    104 1Sugammadex Sodium

    105 1Sulopenem

    106 1Tebipenem Pivoxil Hydrobromide

    107 1Tetracaine Hydrochloride

    108 1Ticagrelor

    109 2Tigecycline

    110 1Tomopenem

    111 2Topiramate

    112 1Trientine Hydrochloride

    113 1Urinastatin

    114 1Valacyclovir

    115 1Vildagliptin

    116 1Voriconazole

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    01

    Albendazole

    India

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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17754

    Submission : 2004-11-08

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

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    NDC KDMF VMF Others AUDIT
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    02

    Armodafinil

    India

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

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    OTS 2025
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-05

    Pay. Date : 2014-01-22

    DMF Number : 24945

    Submission : 2011-06-01

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

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    03

    Benazepril Hydrochloride

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-06

    Pay. Date : 2013-01-17

    DMF Number : 19479

    Submission : 2006-05-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

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    04

    Buspirone Hydrochloride

    India

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    DMF Review : Reviewed

    Rev. Date : 2014-05-13

    Pay. Date : 2014-01-20

    DMF Number : 25361

    Submission : 2011-11-16

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

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    05

    Dronedarone Hydrochloride

    India

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

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    OTS 2025
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-30

    Pay. Date : 2013-06-24

    DMF Number : 25669

    Submission : 2012-02-16

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Febuxostat

    India

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

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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-25

    Pay. Date : 2013-01-29

    DMF Number : 25761

    Submission : 2012-02-24

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Flecainide

    India

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

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    OTS 2025
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19272

    Submission : 2006-03-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Lamotrigine

    India

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

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    OTS 2025
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22813

    Submission : 2009-05-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    09

    Lanthanum Carbonate

    India

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

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    OTS 2025
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-14

    Pay. Date : 2015-12-08

    DMF Number : 23254

    Submission : 2009-11-05

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    10

    Lisinopril

    India

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

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    OTS 2025
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-10

    Pay. Date : 2013-03-13

    DMF Number : 17626

    Submission : 2004-08-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-04-23

    Valid Till : 2027-04-22

    Written Confirmation Number : WC-0170

    Address of the Firm :

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    Contact Shamrock Pharmachemi and get a quotation

    Shamrock Pharmachemi is a supplier offers 99 products (APIs, Excipients or Intermediates).

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