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    01 1Albendazole

    02 1Alendronate Sodium

    03 1Alfuzosin HCl

    04 1Alogliptin Benzoate

    05 1Amlodipine

    06 10Amlodipine Besylate

    07 1Anagrelide Hydrochloride

    08 1Anastrozole

    09 1Apalutamide

    10 1Apixaban

    11 1Apremilast

    12 1Aprindine Hydrochloride

    13 1Aripiprazole

    14 1Arsenic Trioxide

    15 1Aspirin

    16 1Atenolol

    17 2Atomoxetin Hydrochloride

    18 5Atorvastatin

    19 1Atovaquone

    20 1Azathioprine

    21 3Azelastine Hydrochloride

    22 1Azelnidipine

    23 2Azilsartan

    24 2Benazepril Hydrochloride

    25 1Benzoyl Peroxide

    26 1Bosentan Hydrate

    27 1Brexpiprazole

    28 1Brivaracetam

    29 2Bupropion Hydrochloride

    30 1Buspirone Hydrochloride

    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 1Letermovir

    99 2Letrozole

    100 1Levofloxacin

    101 1Levofloxacin Hemihydrate

    102 1Levomilnacipran

    103 1Linagliptin

    104 1Linezolid

    105 12Loratadine

    106 1Lorcaserin HCl

    107 1Lornoxicam

    108 2Losartan Potassium

    109 1Lumateperone Tosylate

    110 1Lurasidone Hydrochloride

    111 1Macitentan

    112 2Meloxicam

    113 2Memantine Hydrochloride

    114 2Mesalazine

    115 1Metoprolol Succinate

    116 2Midodrine

    117 1Milnacipran HCl

    118 1Mirabegron

    119 1Naftopidil

    120 1Nateglinide

    121 5Nebivolol

    122 1Nicorandil

    123 2Olanzapine

    124 1Olmesartan Medoxomil

    125 2Omeprazole

    126 2Ondansetron Hydrochloride

    127 1Oseltamivir Phosphate

    128 1Otilonium Bromide

    129 1Oxaliplatin

    130 1Paliperidone

    131 3Pantoprazole Sodium

    132 3Paroxetine Hydrochloride

    133 1Pentoxifylline

    134 1Perampanel

    135 1Phentermine Hydrochloride

    136 1Pimavanserin Tartrate

    137 1Pioglitazone Hydrochloride

    138 1Pitavastatin

    139 1Pitavastatin Magnesium

    140 2Podophyllotoxin

    141 1Policresulen

    142 2Pramipexole Dihydrochloride

    143 3Pregabalin

    144 1Proguanil

    145 1Promethazine Hydrochloride

    146 1Propafenone Hydrochloride

    147 1Quetiapine Hemifumarate

    148 2Rabeprazole Sodium

    149 2Ranolazine

    150 2Rifaximin

    151 1Risperidone

    152 1Rivastigmine

    153 1Roflumilast

    154 1Rosuvastatin Calcium

    155 1Rupatadine Fumarate

    156 1Salmeterol Xinafoate

    157 1Saxagliptin

    158 1Semaglutide

    159 1Sertraline Hydrochloride

    160 1Silodosin

    161 3Simvastatin

    162 3Sitagliptin Phosphate

    163 1Sofosbuvir

    164 1Solifenacin Succinate

    165 1Succinylcholine Chloride

    166 1Suvorexant

    167 2Tamsulosin

    168 1Telmisartan

    169 1Terazosin HCl

    170 1Teriflunomide

    171 1Tirofiban

    172 1Tizanidine Hydrochloride

    173 1Tofacitinib Citrate

    174 2Topiramate

    175 2Tramadol Hydrochloride

    176 1Trazodone Hydrochloride

    177 2Urapidil Hydrochloride

    178 1Valacyclovir Hydrochloride

    179 2Valsartan

    180 3Venlafaxine Hydrochloride

    181 1Vilazodone Hydrochloride

    182 1Vildagliptin

    183 1Viloxazine Hydrochloride

    184 2Vortioxetine Hydrobromide

    185 1Voxelotor

    186 1Warfarin Sodium

    187 1Zaleplon

    188 2Ziprasidone Hydrochloride

    189 1Zolpidem Tartrate

    190 1Zonisamide

    191 8Blank

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    01

    Mesalazine

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

    FCE Pharma
    Not Confirmed
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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 2024-395 - Rev 00

    Issue Date : 2024-11-13

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
    ✖

    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-WCarrow-down
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    Date of Issue : 2022-11-11

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC arrow-down
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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

    KDMF VMF Others AUDIT
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    02

    Paroxetine Hydrochloride

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

    FCE Pharma
    Not Confirmed
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    Paroxetine Hydrochloride

    India

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

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    FCE Pharma
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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
    ✖

    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-WCarrow-down
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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

    KDMF arrow-down
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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

    FCE Pharma
    Not Confirmed
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    Tramadol Hydrochloride

    India

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

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    FCE Pharma
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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
    ✖

    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-WCarrow-down
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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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    04

    Losartan Potassium

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

    FCE Pharma
    Not Confirmed
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    Losartan Potassium

    India

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

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    FCE Pharma
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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-WCarrow-down
    ✖

    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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    05

    Valsartan

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

    FCE Pharma
    Not Confirmed
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    Valsartan

    India

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

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    FCE Pharma
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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-WCarrow-down
    ✖

    Date of Issue : 2022-11-04

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Amlodipine Besylate

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

    FCE Pharma
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    FCE Pharma
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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
    ✖

    Certificate Number : R1-CEP 2007-280 - Rev 08

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF EU-WCarrow-down
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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 : 65841-014

    Start Marketing Date : 2024-09-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : (주)애거슨바이오

    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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    07

    Aripiprazole

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

    FCE Pharma
    Not Confirmed
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    Aripiprazole

    India

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

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    FCE Pharma
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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-WCarrow-down
    ✖

    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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    08

    Atenolol

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

    FCE Pharma
    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
    ✖

    Certificate Number : R1-CEP 2004-169 - Rev 04

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 703

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

    NDC arrow-down
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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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    09

    Atomoxetin Hydrochloride

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

    FCE Pharma
    Not Confirmed
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    Atomoxetin Hydrochloride

    India

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

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    FCE Pharma
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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
    ✖

    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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    10

    Atorvastatin

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    Atorvastatin

    India

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18822

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-079 - Rev 02

    Issue Date : 2024-08-29

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-11-04

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : (주)에스지바이오켐

    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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