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    01 2Abacavir

    02 2Abacavir Sulfate

    03 1Abemaciclib

    04 3Abiraterone Acetate

    05 2Acyclovir

    06 2Afatinib

    07 1Alectinib Hydrochloride

    08 1Alfuzosin HCl

    09 1Allopurinol

    10 1Alogliptin Benzoate

    11 1Amifampridine Phosphate

    12 1Aminocaproic Acid

    13 8Amlodipine Besylate

    14 1Anastrozole

    15 2Apalutamide

    16 1Apixaban

    17 1Apremilast

    18 2Aprepitant

    19 1Arginine Vasopressin

    20 5Aripiprazole

    21 1Asciminib

    22 2Atazanavir Sulfate

    23 1Atogepant

    24 7Atomoxetin Hydrochloride

    25 4Atorvastatin

    26 2Atovaquone

    27 1Avacopan

    28 1Avanafil

    29 1Avatrombopag Maleate

    30 1Axitinib

    31 1Azacitidine

    32 1Azilsartan

    33 1Belumosudil

    34 1Belzutifan

    35 1Bempedoic Acid

    36 1Bendamustine Hydrochloride

    37 1Berotralstat Hydrochloride

    38 1Bexarotene

    39 2Bicalutamide

    40 1Bictegravir

    41 1Bictegravir Sodium

    42 2Bortezomib

    43 1Bosentan Hydrate

    44 1Bosutinib

    45 1Bosutinib Monohydrate

    46 1Brexpiprazole

    47 1Brivaracetam

    48 1Bupropion Hydrobromide

    49 2Bupropion Hydrochloride

    50 1Busulfan

    51 1Cabazitaxel

    52 1Candesartan Cilexetil

    53 1Capecitabine

    54 1Carbamazepine

    55 1Carbidopa

    56 1Carboplatin

    57 1Carfilzomib

    58 1Cefprozil

    59 1Celecoxib

    60 1Cilazapril

    61 2Cinacalcet Hydrochloride

    62 1Cisplatin

    63 2Citalopram Hydrobromide

    64 1Clopidogrel

    65 1Crizotinib

    66 1Cyclobenzaprine

    67 1Cyclophosphamide

    68 1Dabigatran Etexilate Mesylate

    69 1Daclatasvir

    70 1Darolutamide

    71 2Darunavir

    72 2Darunavir Ethanolate

    73 2Dasatinib

    74 1Desloratadine

    75 1Desogestrel

    76 1Desvenlafaxine Succinate

    77 1Deutetrabenazine

    78 2Dexlansoprazole

    79 1Diclofenac Diethylamine

    80 1Diclofenac Potassium

    81 1Diclofenac Sodium

    82 1Didanosine

    83 1Diltiazem

    84 1Diltiazem Hydrochloride

    85 1Dimethyl Fumarate

    86 1Divalproex Sodium

    87 2Docetaxel

    88 2Dolutegravir Sodium

    89 5Donepezil

    90 2Doravirine

    91 2Dorzolamide Hydrochloride

    92 1Doxylamine Succinate

    93 1Droxidopa

    94 3Duloxetine Hydrochloride

    95 2Dutasteride

    96 1Edaravone

    97 1Edoxaban Tosylate

    98 4Efavirenz

    99 2Elagolix Sodium

    100 1Eletriptan Hydrobromide

    101 2Eliglustat

    102 2Eltrombopag

    103 1Empagliflozin

    104 2Emtricitabine

    105 1Entacapone

    106 1Entecavir

    107 1Entecavir Monohydrate

    108 1Enzalutamide

    109 1Eplerenone

    110 1Eprosartan Mesylate

    111 1Erlotinib Hydrochloride

    112 8Escitalopram Oxalate

    113 10Esomeprazole Magnesium

    114 1Esomeprazole Sodium

    115 1Ethinyl Estradiol

    116 1Etilevodopa

    117 1Etoricoxib

    118 3Etravirine

    119 4Ezetimibe

    120 1Famciclovir

    121 1Famotidine

    122 1Febuxostat

    123 1Felbamate

    124 1Fenofibrate

    125 1Ferric Carboxymaltose

    126 1Ferric Citrate

    127 1Ferumoxytol

    128 1Fesoterodine

    129 1Fexofenadine Hydrochloride

    130 2Finasteride

    131 1Fosaprepitant

    132 1Fosinopril

    133 2Fostamatinib Disodium Hexahydrate

    134 2Gabapentin

    135 1Gatifloxacin

    136 1Gefitinib

    137 2Gemcitabine

    138 1Glimepiride

    139 1Glycerol Phenylbutyrate

    140 2Hydralazine Hydrochloride

    141 1Hydroxychloroquine Sulphate

    142 1Ibrutinib

    143 3Imatinib Mesylate

    144 1Indomethacin

    145 2Irbesartan

    146 2Irinotecan Hydrochloride

    147 1Iron Sucrose

    148 1Isotretinoin

    149 2Itraconazole

    150 1Ivabradine Hydrochloride

    151 1Ivacaftor

    152 1Lacosamide

    153 3Lamivudine

    154 4Lansoprazole

    155 1Lapatinib Ditosylate

    156 1Ledipasvir

    157 2Lenacapavir

    158 4Lenalidomide

    159 1Lenvatinib

    160 1Lenvatinib Mesylate

    161 2Lercanidipine

    162 1Letrozole

    163 4Levetiracetam

    164 1Levofloxacin

    165 3Levofloxacin Hemihydrate

    166 1Levonorgestrel

    167 1Lidocaine Hydrochloride

    168 3Lisinopril

    169 3Lopinavir

    170 1Loratadine

    171 2Losartan Potassium

    172 1Lurasidone Hydrochloride

    173 2Maraviroc

    174 1Melphalan Hydrochloride

    175 10Memantine Hydrochloride

    176 1Metaxalone

    177 2Metoprolol Succinate

    178 1Mexiletine

    179 1Micafungin

    180 1Midostaurin

    181 1Milnacipran HCl

    182 1Milnacipran Hydrochloride

    183 2Mirabegron

    184 2Mirtazapine

    185 1Montelukast Sodium

    186 2Moxifloxacin Hydrochloride

    187 1Nabumetone

    188 1Naproxen

    189 1Naproxen Sodium

    190 3Nebivolol

    191 2Nevirapine

    192 1Nilotinib

    193 2Nintedanib Esylate

    194 1Obeticholic Acid

    195 2Olanzapine

    196 1Olaparib

    197 1Olmesartan Medoxomil

    198 2Omeprazole

    199 1Omeprazole Magnesium

    200 1Opicapone

    201 3Oseltamivir Phosphate

    202 3Osimertinib Mesylate

    203 1Oxaliplatin

    204 1Paclitaxel

    205 2Palbociclib

    206 1Pantoprazole Magnesium

    207 2Pantoprazole Sodium

    208 1Pazopanib Hydrochloride

    209 1Pemetrexed Disodium

    210 1Perindopril Erbumine

    211 3Pioglitazone Hydrochloride

    212 1Pitavastatin

    213 1Plerixafor

    214 1Pomalidomide

    215 1Pralatrexate

    216 2Pramipexole Dihydrochloride

    217 1Prasugrel Hydrochloride

    218 2Pregabalin

    219 1Progesterone

    220 1Proguanil

    221 5Quetiapine Hemifumarate

    222 1Rabeprazole Sodium

    223 1Raloxifene Hydrochloride

    224 3Raltegravir Potassium

    225 2Ramipril

    226 1Regorafenib

    227 1Relugolix

    228 1Rifaximin

    229 1Rilpivirine

    230 1Rilpivirine Hydrochloride

    231 1Riluzole

    232 2Risedronate Sodium

    233 4Ritonavir

    234 1Rivaroxaban

    235 1Rivastigmine

    236 1Rizatriptan Benzoate

    237 1Roflumilast

    238 1Rosuvastatin Calcium

    239 1Rufinamide

    240 2Saquinavir Mesylate

    241 1Saxagliptin Hydrochloride

    242 1Selenious Acid

    243 4Sertraline Hydrochloride

    244 2Sevelamer Carbonate

    245 1Sevelamer Hydrochloride

    246 2Sildenafil Citrate

    247 1Silodosin

    248 2Simvastatin

    249 1Sodium Zirconium Cyclosilicate

    250 1Sofosbuvir

    251 1Solifenacin Succinate

    252 1Solriamfetol Hydrochloride

    253 2Sorafenib

    254 1Sotorasib

    255 1Stavudine

    256 2Sunitinib

    257 2Telmisartan

    258 1Temozolomide

    259 3Tenofovir Alafenamide Fumarate

    260 3Tenofovir Disoproxil Fumarate

    261 2Terbinafine Hydrochloride

    262 1Testosterone

    263 1Tetrabenazine

    264 1Thalidomide

    265 1Tipiracil Hydrochloride

    266 1Tizanidine Hydrochloride

    267 1Tolterodine Tartrate

    268 2Tolvaptan

    269 2Topiramate

    270 2Torsemide

    271 1Trandolapril

    272 1Trifluridine

    273 1Trilaciclib Dihydrochloride

    274 2Valacyclovir Hydrochloride

    275 2Valganciclovir Hydrochloride

    276 4Valsartan

    277 2Varenicline Tartrate

    278 1Velpatasvir

    279 1Venetoclax

    280 1Venlafaxine Hydrochloride

    281 1Vericiguat

    282 2Vigabatrin

    283 1Vismodegib

    284 2Voriconazole

    285 2Vortioxetine Hydrobromide

    286 1Zafirlukast

    287 3Zidovudine

    288 1Ziprasidone Hydrochloride

    289 2Zoledronic Acid

    290 1Zolmitriptan

    291 3Zonisamide

    292 10Blank

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    01

    Anastrozole

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

    Pharmex
    Not Confirmed
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    Anastrozole

    India

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

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    Pharmex
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-02

    Pay. Date : 2014-02-18

    DMF Number : 22231

    Submission : 2008-12-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-172 - Rev 01

    Issue Date : 2020-12-15

    Type : Chemical

    Substance Number : 2406

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10140

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-08-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0026

    Start Marketing Date : 1995-12-27

    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

    Aripiprazole

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

    Pharmex
    Not Confirmed
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    Aripiprazole

    India

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

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    Pharmex
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-21

    DMF Number : 22563

    Submission : 2009-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-361 - Rev 02

    Issue Date : 2025-05-16

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10017

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 68554-0020

    Start Marketing Date : 2002-11-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Unimed Pharmaceutical Co., Ltd.

    Registration Date : 2020-06-22

    Registration Number : 20190314-209-J-189(4)

    Manufacturer Name : Hetero Labs Limited(Unit-I)

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Andhra Pradesh, INDIA

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    03

    Atomoxetin Hydrochloride

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

    Pharmex
    Not Confirmed
    arrow

    Atomoxetin Hydrochloride

    India

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

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    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20246

    Submission : 2007-02-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-128 - Rev 01

    Issue Date : 2022-08-29

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10156

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-08-08

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 68554-0149

    Start Marketing Date : 2002-11-26

    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 : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : No. 3838-3-ND(7)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, INDIA

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    04

    Atorvastatin

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

    Pharmex
    Not Confirmed
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    Atorvastatin

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-07

    Pay. Date : 2012-12-11

    DMF Number : 26122

    Submission : 2012-06-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-049 - Rev 03

    Issue Date : 2025-05-19

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10202

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2017-11-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0065

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 65977-0127

    Start Marketing Date : 2004-07-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Neo Co., Ltd.

    Registration Date : 2023-07-19

    Registration Number : 20200318-132-H-354-44(3)

    Manufacturer Name : Hetero Labs Limited (Unit-IX)

    Manufacturer Address : Plot No.2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531 081, Andhra Pradesh, India

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    05

    Bicalutamide

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

    Pharmex
    Not Confirmed
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    Bicalutamide

    India

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

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    Pharmex
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18496

    Submission : 2005-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-254 - Rev 03

    Issue Date : 2025-04-07

    Type : Chemical

    Substance Number : 2196

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10046

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2014-02-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0001

    Start Marketing Date : 1995-10-04

    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

    Capecitabine

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

    Pharmex
    Not Confirmed
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    Capecitabine

    India

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

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    Pharmex
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-12-18

    Pay. Date : 2013-06-21

    DMF Number : 22140

    Submission : 2008-10-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-355 - Rev 04

    Issue Date : 2025-05-20

    Type : Chemical

    Substance Number : 2762

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10215

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2016-11-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0033

    Start Marketing Date : 1998-04-30

    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 : 2021-03-10

    Registration Number : 20210310-209-J-685

    Manufacturer Name : Hetero Labs Limited(Unit-1)

    Manufacturer Address : Sy.No.10, IDA,Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, India

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    07

    Celecoxib

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

    Pharmex
    Not Confirmed
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    Celecoxib

    India

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

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    Pharmex
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-12-05

    Pay. Date : 2013-10-01

    DMF Number : 24557

    Submission : 2011-01-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-037 - Rev 02

    Issue Date : 2025-06-13

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10025

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telangana, INDIA

    Initial Date of Registration : 2019-02-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-09-30

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0066

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0052

    Start Marketing Date : 1998-12-31

    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 : 2024-12-23

    Registration Number : 20241223-209-J-1735

    Manufacturer Name : Hetero Drugs Limited Unit IX

    Manufacturer Address : Plot No.1, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District-531081, Andhra Pradesh, India

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    08

    Dutasteride

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

    Pharmex
    Not Confirmed
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    Dutasteride

    India

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

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    Pharmex
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-04

    Pay. Date : 2013-12-10

    DMF Number : 27774

    Submission : 2013-12-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-126 - Rev 00

    Issue Date : 2022-07-26

    Type : Chemical

    Substance Number : 2641

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 231MF10024

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2019-02-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0079

    Start Marketing Date : 2001-11-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2020-02-03

    Registration Number : No. 473-21-ND(1)

    Manufacturer Name : Hetero Labs Limited(Unit-I)

    Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Andhra Pradesh, INDIA

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    09

    Eplerenone

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

    Pharmex
    Not Confirmed
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    Eplerenone

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-10-16

    Pay. Date : 2019-09-24

    DMF Number : 33832

    Submission : 2019-05-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-263 - Rev 02

    Issue Date : 2024-03-05

    Type : Chemical

    Substance Number : 2765

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10031

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2022-02-10

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0116

    Start Marketing Date : 2002-09-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Escitalopram Oxalate

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

    Pharmex
    Not Confirmed
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    Escitalopram Oxalate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-17

    Pay. Date : 2013-03-07

    DMF Number : 17960

    Submission : 2004-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-080 - Rev 06

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2733

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10125

    Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0136

    Start Marketing Date : 2002-08-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmawon Co., Ltd.

    Registration Date : 2021-04-21

    Registration Number : 20180604-209-J-223(8)

    Manufacturer Name : Hetero Labs Limited

    Manufacturer Address : Survey. No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State India

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    Hetero is a supplier offers 419 products (APIs, Excipients or Intermediates).

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    Find a price of Eletriptan Hydrobromide bulk with DMF, JDMF, WC offered by Hetero

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    Find a price of Erlotinib Hydrochloride bulk with DMF, JDMF, WC offered by Hetero

    Find a price of Escitalopram Oxalate bulk with DMF, CEP, JDMF offered by Hetero

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