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    01 1Adapalene

    02 1Alfuzosin HCl

    03 1Alogliptin Benzoate

    04 2Amiodarone Hydrochloride

    05 4Apixaban

    06 1Apremilast

    07 4Aprepitant

    08 1Arformoterol Tartrate

    09 1Atomoxetin Hydrochloride

    10 2Atovaquone

    11 2Azelaic Acid

    12 1Bilastine

    13 1Bisoprolol Fumarate

    14 1Bosentan Hydrate

    15 1Brivaracetam

    16 1Bupropion Hydrobromide

    17 1Bupropion Hydrochloride

    18 1Carvedilol

    19 1Choline Fenofibrate

    20 2Cilazapril

    21 2Cilostazol

    22 1Colistimethate Sodium

    23 1Crofelemer

    24 2Dabigatran Etexilate Mesylate

    25 1Daclatasvir

    26 1Dapagliflozin

    27 1Darifenacin Hydrobromide

    28 2Deferasirox

    29 1Deoxycholic Acid

    30 2Desloratadine

    31 1Dimethyl Fumarate

    32 1Dipyridamole

    33 1Diroximel fumarate

    34 1Dronedarone Hydrochloride

    35 1Efinaconazole

    36 1Elagolix Sodium

    37 1Enzalutamide

    38 9Esomeprazole Magnesium

    39 1Esomeprazole Sodium

    40 1Eszopiclone

    41 2Etoricoxib

    42 9Ezetimibe

    43 1Finerenone

    44 1Fingolimod Hydrochloride

    45 2Fluconazole

    46 1Fluvoxamine

    47 2Fosaprepitant

    48 3Frovatriptan Succinate Hydrate

    49 1Gabapentin Enacarbil

    50 6Glimepiride

    51 1Hydralazine Hydrochloride

    52 2Imiquimod

    53 1Iron Sucrose

    54 1Isavuconazonium Sulfate

    55 1Itraconazole

    56 1Ivacaftor

    57 1Labetalol Hydrochloride

    58 1Lacosamide

    59 2Lercanidipine

    60 1Levocetirizine Dihydrochloride

    61 2Lifitegrast

    62 3Linagliptin

    63 2Linezolid

    64 2Lithium Carbonate

    65 1Lomitapide

    66 1Loratadine

    67 1Lornoxicam

    68 1Luliconazole

    69 1Lurasidone Hydrochloride

    70 1Milnacipran Hydrochloride

    71 5Mirabegron

    72 1Moexipril

    73 1Nintedanib Esylate

    74 1Olaparib

    75 2Olmesartan Medoxomil

    76 1Olopatadine Hydrochloride

    77 1Omeprazole

    78 1Ospemifene

    79 1Oxcarbazepine

    80 1Palbociclib

    81 1Paliperidone

    82 1Paliperidone Palmitate

    83 1Palonosetron

    84 1Perindopril

    85 1Perindopril Arginine

    86 2Perindopril Erbumine

    87 1Pirfenidone

    88 1Potassium Chloride

    89 1Prasugrel

    90 1Prasugrel Hydrochloride

    91 1Pregabalin

    92 1Proguanil

    93 1Propranolol Hydrochloride

    94 1Raloxifene Hydrochloride

    95 1Ranolazine

    96 5Rasagiline Mesylate

    97 1Rasagiline Tartrate

    98 1Relugolix

    99 2Riluzole

    100 1Rivaroxaban

    101 1Rizatriptan Benzoate

    102 1Roflumilast

    103 1Ropinirole Hydrochloride

    104 4Rosuvastatin Calcium

    105 1Rufinamide

    106 1Ruxolitinib Phosphate

    107 1Saxagliptin

    108 1Sertaconazole Nitrate

    109 3Sitagliptin Phosphate

    110 1Sodium Bicarbonate

    111 4Solifenacin Succinate

    112 1Solriamfetol Hydrochloride

    113 1Strontium Ranelate

    114 2Sucralfate

    115 2Tadalafil

    116 1Tafamidis

    117 1Tafamidis Meglumine

    118 1Tavaborole

    119 1Tazarotene

    120 1Telaprevir

    121 3Telmisartan

    122 1Teneligliptin Hydrobromide

    123 2Terbinafine Hydrochloride

    124 1Teriflunomide

    125 1Ticagrelor

    126 1Tivozanib

    127 4Tofacitinib Citrate

    128 3Topiramate

    129 1Trandolapril

    130 1Trazodone Hydrochloride

    131 1Trospium Chloride

    132 1Ursodeoxycholic Acid

    133 1Verapamil Hydrochloride

    134 1Vilazodone Hydrochloride

    135 1Vildagliptin

    136 2Voriconazole

    137 1Zolmitriptan

    138 2Zolpidem Tartrate

    139 2Zonisamide

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    01

    Adapalene

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

    IOPC
    Not Confirmed
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    Adapalene

    India

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

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    IOPC
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-08

    Pay. Date : 2012-11-26

    DMF Number : 18756

    Submission : 2005-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-207 - Rev 02

    Issue Date : 2025-04-03

    Type : Chemical

    Substance Number : 2445

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10072

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2014-03-11

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-801

    Start Marketing Date : 2005-09-12

    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

    Esomeprazole Magnesium

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

    IOPC
    Not Confirmed
    arrow

    Esomeprazole Magnesium

    India

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

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    IOPC
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-05

    Pay. Date : 2013-03-08

    DMF Number : 20222

    Submission : 2007-01-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-258 - Rev 03

    Issue Date : 2025-04-07

    Type : Chemical

    Substance Number : 2787

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10113

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2021-07-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2026-11-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-892

    Start Marketing Date : 2013-01-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : (주)에스지바이오켐

    Registration Date : 2023-12-27

    Registration Number : 20230925-127-H-416-46(1)

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC Industrial Estate Ankleshwar - 393 002, Dist. Bharuch, Gujarat State, India

     VMF Others AUDIT
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    03

    Rizatriptan Benzoate

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

    IOPC
    Not Confirmed
    arrow

    Rizatriptan Benzoate

    India

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

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    IOPC
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22676

    Submission : 2009-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-108 - Rev 03

    Issue Date : 2025-04-04

    Type : Chemical

    Substance Number : 2585

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10064

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2016-02-24

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-835

    Start Marketing Date : 2009-03-31

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Ropinirole Hydrochloride

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

    IOPC
    Not Confirmed
    arrow

    Ropinirole Hydrochloride

    India

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

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    IOPC
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-11-16

    Pay. Date : 2022-11-14

    DMF Number : 20593

    Submission : 2007-06-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-242 - Rev 02

    Issue Date : 2025-03-18

    Type : Chemical

    Substance Number : 2604

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10031

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2015-01-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-853

    Start Marketing Date : 2007-06-12

    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

    Solifenacin Succinate

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

    IOPC
    Not Confirmed
    arrow

    Solifenacin Succinate

    India

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

    arrow
    IOPC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-17

    Pay. Date : 2012-12-07

    DMF Number : 22418

    Submission : 2009-01-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-249 - Rev 03

    Issue Date : 2025-04-09

    Type : Chemical

    Substance Number : 2779

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10112

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2024-08-22

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-858

    Start Marketing Date : 2009-01-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Astellas Pharma Korea Co., Ltd.

    Registration Date : 2024-09-04

    Registration Number : No. 4692-7-ND(3)

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109-C, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gurajat State, India

     VMF Others AUDIT
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    06

    Tadalafil

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

    IOPC
    Not Confirmed
    arrow

    Tadalafil

    India

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

    arrow
    IOPC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22530

    Submission : 2009-02-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-040 - Rev 01

    Issue Date : 2025-04-09

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10055

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2026-11-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-921

    Start Marketing Date : 2015-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    Registration Date : 2014-02-07

    Registration Number : 20140207-203-I-371-06

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar. City : Ankleshwar - 393 002, Dist : Bharuch, Gujarat State, India

     VMF Others AUDIT
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    07

    Telmisartan

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

    IOPC
    Not Confirmed
    arrow

    Telmisartan

    India

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

    arrow
    IOPC
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-25

    Pay. Date : 2014-05-23

    DMF Number : 27804

    Submission : 2014-05-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-184 - Rev 01

    Issue Date : 2025-04-10

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10093

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2013-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Voriconazole

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

    IOPC
    Not Confirmed
    arrow

    Voriconazole

    India

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

    arrow
    IOPC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-14

    Pay. Date : 2013-12-13

    DMF Number : 24717

    Submission : 2011-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-102 - Rev 03

    Issue Date : 2025-04-14

    Type : Chemical

    Substance Number : 2576

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10092

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2013-05-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2026-11-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-876

    Start Marketing Date : 2011-08-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2020-07-21

    Registration Number : 20200721-209-J-382

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109, GIDC Industrial Estate, Ankleshwar City : Ankleshwar - 393 002, Dist : Bharuch, Gujarat State, India

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    09

    Zolpidem Tartrate

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

    IOPC
    Not Confirmed
    arrow

    Zolpidem Tartrate

    India

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

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    IOPC
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-31

    Pay. Date : 2013-01-04

    DMF Number : 18164

    Submission : 2005-03-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-102 - Rev 05

    Issue Date : 2025-04-14

    Type : Chemical

    Substance Number : 1280

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 227MF10236

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2015-09-24

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-06-25

    Written Confirmation Number : WC-0057n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-810

    Start Marketing Date : 2005-03-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Telmisartan

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

    IOPC
    Not Confirmed
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    Telmisartan

    India

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

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    IOPC
    Not Confirmed
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    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20575

    Submission : 2007-05-25

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-028 - Rev 07

    Issue Date : 2025-04-09

    Type : Chemical

    Substance Number : 2154

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10025

    Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India

    Initial Date of Registration : 2016-02-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2026-11-28

    Written Confirmation Number : WC-0310

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 66039-895

    Start Marketing Date : 2014-05-23

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2018-05-09

    Registration Number : 20180509-209-J-30

    Manufacturer Name : Glenmark Life Sciences Limited

    Manufacturer Address : Plot No. 3109-GIDC Industrial Estate ANKLESHWAR-393002 Dist. Bharuch, Gujarat, India

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