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    01 1Acoramidis Hydrochloride

    02 1Acotiamide

    03 4Alogliptin Benzoate

    04 3Apixaban

    05 1Aprocitentan

    06 1Aripiprazole

    07 1Aripiprazole Lauroxil

    08 1Atazanavir Sulfate

    09 1Atogepant

    10 1Atomoxetin Hydrochloride

    11 1Avanafil

    12 1Avatrombopag Maleate

    13 3Azilsartan

    14 1Balofloxacin

    15 1Bedaquiline

    16 1Bempedoic Acid

    17 1Bexagliflozin

    18 1Bosentan Hydrate

    19 1Brexpiprazole

    20 3Brivaracetam

    21 5CAS 654671-77-9

    22 1Cabotegravir

    23 1Cabotegravir Sodium

    24 1Calcium Gluconate

    25 1Cariprazine Hydrochloride

    26 1Chlorthalidone

    27 1Cilnidipine

    28 1Clobazam

    29 1Clorazepate Dipotassium

    30 1Cobicistat

    31 1Colchicine

    32 1Crisaborole

    33 1Cysteamine Bitartrate

    34 1Dapagliflozin

    35 8Dapagliflozin Propanediol Monohydrate

    36 1Darunavir

    37 1Diatrizoate Meglumine

    38 1Diatrizoate Sodium

    39 1Dicyclomine Hydrochloride

    40 1Dimethyl Fumarate

    41 1Diroximel fumarate

    42 1Dolutegravir Sodium

    43 1Doxylamine Succinate

    44 1Edaravone

    45 2Edoxaban Tosylate

    46 1Elafibranor

    47 1Eluxadoline

    48 1Elvitegravir

    49 15Empagliflozin

    50 1Emtricitabine

    51 1Ertugliflozin

    52 1Etrasimod Arginine

    53 1Favipiravir

    54 1Filgotinib

    55 1Fingolimod Hydrochloride

    56 1Fosfomycin Trometamol

    57 1Gemifloxacin

    58 1Glycinehydrochloride

    59 1Hydralazine Hydrochloride

    60 1Icosapent Ethyl

    61 1Ipragliflozin

    62 1Iptacopan Hydrochloride

    63 1Isavuconazonium Sulfate

    64 1Istradefylline

    65 1L-Glutamine

    66 1Lercanidipine

    67 1Letermovir

    68 1Levetiracetam

    69 1Lifitegrast

    70 5Linagliptin

    71 1Lithium Carbonate

    72 1Lopinavir

    73 1Macitentan

    74 1Maralixibat

    75 2Maraviroc

    76 1Maribavir

    77 1Mirabegron

    78 1Mirogabalin Besylate

    79 1Molnupiravir

    80 1Monomethyl Fumarate

    81 1Moxonidine

    82 1Nebivolol

    83 1Nirmatrelvir

    84 1Ospemifene

    85 1Oxcarbazepine

    86 2Pirfenidone

    87 1Polmacoxib

    88 1Posaconazole

    89 1Prulifloxacin

    90 1Pyridoxine Hydrochloride

    91 1Quetiapine Hemifumarate

    92 1Ramipril

    93 1Remdesivir

    94 1Riociguat

    95 1Risdiplam

    96 1Ritlecitinib

    97 1Roxadustat

    98 3Sacubitril-Valsartan

    99 1Safinamide Methanesulfonate

    100 1Salcaprozate Sodium

    101 1Sapropterin Hydrochloride

    102 1Saxagliptin

    103 1Seladelpar Lysine

    104 1Selexipag

    105 5Sitagliptin Hydrochloride

    106 2Sitagliptin Phosphate

    107 1Sofosbuvir

    108 1Sotagliflozin

    109 1Sugammadex Sodium

    110 1Suzetrigine

    111 1Tadalafil

    112 1Tafamidis Meglumine

    113 1Tavaborole

    114 1Tedizolid

    115 1Tegoprazan

    116 1Tenapanor

    117 1Teneligliptin Hydrobromide

    118 1Tenofovir Alafenamide Fumarate

    119 1Terbinafine Hydrochloride

    120 1Teriflunomide

    121 3Ticagrelor

    122 1Tilorone Dihydrochloride

    123 1Tofacitinib Citrate

    124 1Torsemide

    125 1Trelagliptin Succinate

    126 1Ubrogepant

    127 1Umifenovir

    128 1Upadacitinib

    129 1Vadadustat

    130 1Vibegron

    131 1Vildagliptin

    132 6Vonoprazan Fumarate

    133 1Xanomeline

    134 1Zavegepant HCl

    135 1Blank

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    01

    Sitagliptin Phosphate

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

    AACR Annual meeting
    Not Confirmed
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    Sitagliptin Phosphate

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-16

    Pay. Date : 2016-09-12

    DMF Number : 30857

    Submission : 2016-09-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-324 - Rev 01

    Issue Date : 2024-12-16

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10124

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

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    NDC Package Code : 69037-0022

    Start Marketing Date : 2016-12-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Tadalafil

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

    AACR Annual meeting
    Not Confirmed
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    Tadalafil

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-08

    Pay. Date : 2015-09-29

    DMF Number : 29765

    Submission : 2015-12-04

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2016-083 - Rev 00

    Issue Date : 2022-07-25

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF arrow-down
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    Registration Number : 230MF10172

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2018-12-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0015

    Start Marketing Date : 2003-11-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Alogliptin Benzoate

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Alogliptin Benzoate

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-09-02

    Pay. Date : 2016-06-13

    DMF Number : 30577

    Submission : 2016-07-18

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10015

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0024

    Start Marketing Date : 2013-01-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Phamchem Service Co., Ltd.

    Registration Date : 2024-01-24

    Registration Number : Su331-11-ND(3)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Nakkapalli Mandal, Anakapalli District, Andhra Pradesh, India

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    04

    Clobazam

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

    AACR Annual meeting
    Not Confirmed
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    Clobazam

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-24

    Pay. Date : 2015-05-26

    DMF Number : 29351

    Submission : 2015-06-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-237 - Rev 00

    Issue Date : 2023-02-13

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0009

    Start Marketing Date : 2011-10-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Fingolimod Hydrochloride

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Fingolimod Hydrochloride

    India

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

    arrow
    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-20

    Pay. Date : 2014-06-16

    DMF Number : 28225

    Submission : 2014-04-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-171 - Rev 01

    Issue Date : 2023-07-27

    Type : Chemical

    Substance Number : 2988

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69037-0006

    Start Marketing Date : 2010-09-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Linagliptin

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Linagliptin

    India

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

    arrow
    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-13

    Pay. Date : 2014-12-23

    DMF Number : 28877

    Submission : 2015-01-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10029

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2023-02-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69037-0010

    Start Marketing Date : 2014-03-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
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    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : No. 4579-15-ND(4)

    Manufacturer Name : Honour Lab Limited Unit III

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, Anakapalli District - 531 081, Andhra Pradesh, India

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    07

    Teriflunomide

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Teriflunomide

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-11-06

    Pay. Date : 2015-09-08

    DMF Number : 29701

    Submission : 2015-10-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-422 - Rev 00

    Issue Date : 2025-04-11

    Type : Chemical

    Substance Number : 3036

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0016

    Start Marketing Date : 2012-09-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Ticagrelor

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Ticagrelor

    India

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

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    AACR Annual meeting
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-13

    Pay. Date : 2014-12-23

    DMF Number : 28879

    Submission : 2015-01-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-131 - Rev 00

    Issue Date : 2024-11-18

    Type : Chemical

    Substance Number : 3087

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0007

    Start Marketing Date : 2011-07-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2018-03-26

    Registration Number : No. 4579-16-ND(2)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Village, Nakkapalli Mandal, Anakapalli District-531081, Andhra Pradesh, India

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    09

    Vildagliptin

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

    AACR Annual meeting
    Not Confirmed
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    Vildagliptin

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36545

    Submission : 2022-01-03

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 230MF10116

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2018-08-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0028

    Start Marketing Date : 2017-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Apixaban

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

    AACR Annual meeting
    Not Confirmed
    arrow

    Apixaban

    India

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

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    AACR Annual meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-07-05

    Pay. Date : 2016-04-26

    DMF Number : 30461

    Submission : 2016-05-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69037-0023

    Start Marketing Date : 2012-12-28

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2020-05-04

    Registration Number : Su331-9-ND(2)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure Ltd., SEZ, N.Narasapuram Village, Nakkapalli Mandal, Anakapalli District, Andhra Pradesh, India

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    Honour Lab is a supplier offers 149 products (APIs, Excipients or Intermediates).

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