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    01 1Albendazole

    02 1Alfuzosin HCl

    03 1Alogliptin Benzoate

    04 1Amlodipine

    05 9Amlodipine Besylate

    06 1Anagrelide Hydrochloride

    07 1Anastrozole

    08 1Apalutamide

    09 1Apixaban

    10 1Apremilast

    11 1Aprindine Hydrochloride

    12 1Aripiprazole

    13 1Arsenic Trioxide

    14 1Aspirin

    15 1Atenolol

    16 2Atomoxetin Hydrochloride

    17 5Atorvastatin

    18 1Atovaquone

    19 1Azathioprine

    20 3Azelastine Hydrochloride

    21 1Azelnidipine

    22 2Azilsartan

    23 1Benazepril Hydrochloride

    24 1Benzoyl Peroxide

    25 1Bosentan Hydrate

    26 1Brexpiprazole

    27 1Brivaracetam

    28 2Bupropion Hydrochloride

    29 1Buspirone Hydrochloride

    30 1CAS 66376-36-1

    31 1Calcium Gluconate

    32 1Canagliflozin

    33 2Candesartan Cilexetil

    34 1Capecitabine

    35 5Carvedilol

    36 19Celecoxib

    37 1Cetilistat

    38 2Chlorthalidone

    39 1Cinacalcet Hydrochloride

    40 1Clindamycin Hydrochloride

    41 1Clindamycin Phosphate

    42 1Clonidine

    43 6Clopidogrel

    44 3Clopidogrel Besylate

    45 1Colestipol

    46 1Dabigatran Etexilate Mesylate

    47 1Daclatasvir

    48 1Dapagliflozin

    49 1Dapagliflozin Propanediol Monohydrate

    50 1Daptomycin

    51 1Darunavir

    52 1Deferiprone

    53 1Desloratadine

    54 2Desvenlafaxine Succinate

    55 1Diclofenac Epolamine

    56 1Dimethyl Fumarate

    57 1Diroximel fumarate

    58 1Donepezil

    59 3Duloxetine Hydrochloride

    60 1Edoxaban Tosylate

    61 1Eltrombopag

    62 1Empagliflozin

    63 1Entecavir

    64 2Enzalutamide

    65 2Erlotinib Hydrochloride

    66 2Escitalopram Oxalate

    67 2Esomeprazole Magnesium

    68 1Esomeprazole Sodium

    69 1Ethacrynic Acid

    70 1Etodolac

    71 1Etoricoxib

    72 2Exemestane

    73 1Famotidine

    74 1Febuxostat

    75 1Fesoterodine

    76 2Fimasartan

    77 1Fingolimod Hydrochloride

    78 2Fluconazole

    79 8Fluoxetine Hydrochloride

    80 1Fluvastatin Sodium

    81 1Gabapentin Enacarbil

    82 2Gatifloxacin

    83 1Gemcitabine

    84 1Glibenclamide

    85 9Glimepiride

    86 1Grapiprant

    87 1Hydrochlorothiazide

    88 2Hydroxychloroquine Sulphate

    89 3Imatinib Mesylate

    90 1Indacaterol Maleate

    91 2Irbesartan

    92 1Irinotecan Hydrochloride

    93 1Ivabradine Hydrochloride

    94 1Labetalol Hydrochloride

    95 1Lacosamide

    96 1Lamotrigine

    97 1Lansoprazole

    98 1Lenalidomide

    99 1Letermovir

    100 2Letrozole

    101 1Levofloxacin

    102 1Levofloxacin Hemihydrate

    103 1Levomilnacipran

    104 1Linagliptin

    105 1Linezolid

    106 12Loratadine

    107 1Lorcaserin HCl

    108 1Lornoxicam

    109 2Losartan Potassium

    110 1Lumateperone Tosylate

    111 1Lurasidone Hydrochloride

    112 1Macitentan

    113 2Meloxicam

    114 2Memantine Hydrochloride

    115 2Mesalazine

    116 1Metoprolol Succinate

    117 2Midodrine

    118 1Milnacipran HCl

    119 1Mirabegron

    120 1Naftopidil

    121 1Nateglinide

    122 5Nebivolol

    123 1Nicorandil

    124 2Olanzapine

    125 1Olmesartan Medoxomil

    126 2Omeprazole

    127 2Ondansetron Hydrochloride

    128 1Oseltamivir Phosphate

    129 1Otilonium Bromide

    130 1Oxaliplatin

    131 1Paliperidone

    132 3Pantoprazole Sodium

    133 3Paroxetine Hydrochloride

    134 1Pentoxifylline

    135 1Perampanel

    136 1Phentermine Hydrochloride

    137 1Pimavanserin Tartrate

    138 1Pioglitazone Hydrochloride

    139 1Pitavastatin

    140 1Pitavastatin Magnesium

    141 2Podophyllotoxin

    142 1Policresulen

    143 2Pramipexole Dihydrochloride

    144 3Pregabalin

    145 1Proguanil

    146 1Promethazine Hydrochloride

    147 1Propafenone Hydrochloride

    148 1Quetiapine Hemifumarate

    149 2Rabeprazole Sodium

    150 2Ranolazine

    151 2Rifaximin

    152 1Risperidone

    153 1Rivastigmine

    154 1Roflumilast

    155 1Rosuvastatin Calcium

    156 1Rupatadine Fumarate

    157 1Salmeterol Xinafoate

    158 1Saxagliptin

    159 1Semaglutide

    160 1Sertraline Hydrochloride

    161 1Silodosin

    162 3Simvastatin

    163 3Sitagliptin Phosphate

    164 1Sofosbuvir

    165 1Solifenacin Succinate

    166 1Succinylcholine Chloride

    167 1Suvorexant

    168 2Tamsulosin

    169 1Telmisartan

    170 1Terazosin HCl

    171 1Teriflunomide

    172 1Tirofiban

    173 1Tizanidine Hydrochloride

    174 1Tofacitinib Citrate

    175 2Topiramate

    176 2Tramadol Hydrochloride

    177 1Trazodone Hydrochloride

    178 2Urapidil Hydrochloride

    179 1Valacyclovir Hydrochloride

    180 2Valsartan

    181 3Venlafaxine Hydrochloride

    182 1Vilazodone Hydrochloride

    183 1Vildagliptin

    184 1Viloxazine Hydrochloride

    185 2Vortioxetine Hydrobromide

    186 1Voxelotor

    187 1Warfarin Sodium

    188 1Zaleplon

    189 2Ziprasidone Hydrochloride

    190 1Zolpidem Tartrate

    191 1Zonisamide

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    01

    Mesalazine

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

    APGA Annual Conference
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    Mesalazine

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-08

    Pay. Date : 2012-12-18

    DMF Number : 22999

    Submission : 2009-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2019-009 - Rev 02

    Issue Date : 2024-07-05

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10044

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-03-15

    Latest Date of Registration :

    EU-WCInactive-api
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    Date of Issue : 2022-11-11

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    NDC Package Code : 65841-186

    Start Marketing Date : 2024-12-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    02

    Paroxetine Hydrochloride

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

    APGA Annual Conference
    Not Confirmed
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    Paroxetine Hydrochloride

    India

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

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    APGA Annual Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16680

    Submission : 2003-06-27

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2004-239 - Rev 07

    Issue Date : 2024-10-28

    Type : Chemical

    Substance Number : 2018

    Status : Valid

     JDMF arrow-down
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    Registration Number : 222MF10207

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2010-07-26

    Latest Date of Registration :

    EU-WCInactive-api
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    Date of Issue : 2022-08-25

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

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    NDC Package Code : 65841-177

    Start Marketing Date : 2024-12-19

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Nuri Pharm Tech

    Registration Date : 2021-11-30

    Registration Number : 20211130-209-J-1162

    Manufacturer Name : Zydus Lifesciences Limited

    Manufacturer Address : 291, GIDC, Estate, Ankleshwar, Gujarat, 393002, India

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    03

    Tramadol Hydrochloride

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

    APGA Annual Conference
    Not Confirmed
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    Tramadol Hydrochloride

    India

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

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    APGA Annual Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17037

    Submission : 2004-02-17

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2004-098 - Rev 05

    Issue Date : 2024-07-16

    Type : Chemical

    Substance Number : 1681

    Status : Valid

     JDMF arrow-down
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    Registration Number : 301MF10065

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2019-09-17

    Latest Date of Registration :

    EU-WCInactive-api
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    Date of Issue : 2022-11-11

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0095

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    04

    Atomoxetin Hydrochloride

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

    APGA Annual Conference
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20364

    Submission : 2007-03-22

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2019-236 - Rev 01

    Issue Date : 2022-07-11

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10088

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-06-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 65841-155

    Start Marketing Date : 2018-01-12

    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 : Pharmapia Co., Ltd.

    Registration Date : 2016-03-30

    Registration Number : No. 4749-10-ND(1)

    Manufacturer Name : Cadila Pharmaceuticals Limited

    Manufacturer Address : 294, GIDC Estate, City: Ankleshwar-393 002, Dist: Bharuch, India.

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    05

    Losartan Potassium

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

    APGA Annual Conference
    Not Confirmed
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    Losartan Potassium

    India

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

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    USDMF Inactive-api
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18153

    Submission : 2005-03-04

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-133 - Rev 09

    Issue Date : 2025-02-28

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2011-08-30

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC KDMF arrow-down
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    Registrant Name : Goodwills Co., Ltd.

    Registration Date : 2011-01-10

    Registration Number : 20110110-122-G-94-29

    Manufacturer Name : Cadila Healthcare Limited

    Manufacturer Address : 291, GIDC Industrial Estate Ankleswar-393 002, Gujarat INDIA

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    06

    Valsartan

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

    APGA Annual Conference
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    Valsartan

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22684

    Submission : 2009-03-31

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-221 - Rev 00

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 2423

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 225MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2013-07-23

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-11-04

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

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    07

    Amlodipine Besylate

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

    APGA Annual Conference
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    APGA Annual Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18827

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2007-280 - Rev 08

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-11-11

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    NDC Package Code : 65841-014

    Start Marketing Date : 2024-09-16

    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 : Agerson Bio Co., Ltd.

    Registration Date : 2021-08-28

    Registration Number : 20130213-130-H-158-43(10)

    Manufacturer Name : Cadila Pharmaceuticals Limited

    Manufacturer Address : 294, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gujarat State, India

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    08

    Aripiprazole

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

    APGA Annual Conference
    Not Confirmed
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    Aripiprazole

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19841

    Submission : 2006-10-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-002 - Rev 01

    Issue Date : 2022-07-11

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

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    NDC Package Code : 65841-140

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Atenolol

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

    APGA Annual Conference
    Not Confirmed
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    Atenolol

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-04-01

    Pay. Date : 2016-03-22

    DMF Number : 14210

    Submission : 1999-06-14

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2004-169 - Rev 04

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 703

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

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    NDC Package Code : 65841-101

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Atorvastatin

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    Atorvastatin

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18822

    Submission : 2005-09-30

    Status : Active

    Type : II

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    Certificate Number : CEP 2021-079 - Rev 02

    Issue Date : 2024-08-29

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-11-04

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

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    Registrant Name : SG Biochem Co., Ltd.

    Registration Date : 2025-01-14

    Registration Number : 20250114-132-H-433-51

    Manufacturer Name : Zydus Lifesciences Limited

    Manufacturer Address : Unit-Ⅱ, Plot No:5/1-B, GIDC Estate, City-Ankleshwar-393 002, Dist-Bharuch Gujarat State, India

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