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    01 2Abacavir

    02 2Abacavir Sulfate

    03 1Abemaciclib

    04 3Abiraterone Acetate

    05 2Acyclovir

    06 2Afatinib

    07 1Alectinib Hydrochloride

    08 1Alfuzosin Hydrochloride

    09 2Allopurinol

    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 6Aripiprazole

    21 1Asciminib

    22 2Atazanavir Sulfate

    23 1Atogepant

    24 7Atomoxetine

    25 4Atorvastatin

    26 2Atovaquone

    27 1Avacopan

    28 1Avanafil

    29 1Avatrombopag Maleate

    30 1Axitinib

    31 1Azacitidine

    32 1Azilsartan Medoxomil Potassium

    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 1Caspofungin

    59 1Cefprozil

    60 1Celecoxib

    61 1Cilazapril

    62 2Cinacalcet Hydrochloride

    63 1Cisplatin

    64 2Citalopram Hydrobromide

    65 1Clopidogrel

    66 1Crizotinib

    67 1Cyclobenzaprine

    68 1Cyclophosphamide

    69 1Dabigatran Etexilate Mesylate

    70 1Daclatasvir

    71 1Darolutamide

    72 2Darunavir

    73 2Darunavir Ethanolate

    74 2Dasatinib

    75 1Desloratadine

    76 1Desogestrel

    77 1Desvenlafaxine Succinate

    78 1Deutetrabenazine

    79 2Dexlansoprazole

    80 1Diclofenac Diethylamine

    81 1Diclofenac Potassium

    82 1Diclofenac Sodium

    83 1Didanosine

    84 1Diltiazem

    85 1Diltiazem Hydrochloride

    86 1Dimethyl Fumarate

    87 1Divalproex Sodium

    88 2Docetaxel

    89 2Dolutegravir Sodium

    90 5Donepezil

    91 2Doravirine

    92 2Dorzolamide Hydrochloride

    93 1Doxylamine Succinate

    94 1Droxidopa

    95 3Duloxetine Hydrochloride

    96 2Dutasteride

    97 1Edaravone

    98 1Edoxaban Tosylate

    99 4Efavirenz

    100 2Elagolix Sodium

    101 1Eletriptan Hydrobromide

    102 2Eliglustat

    103 2Eltrombopag

    104 1Empagliflozin

    105 2Emtricitabine

    106 1Entacapone

    107 1Entecavir

    108 1Entecavir Monohydrate

    109 1Enzalutamide

    110 2Eplerenone

    111 1Eprosartan Mesylate

    112 1Erlotinib Hydrochloride

    113 9Escitalopram Oxalate

    114 9Esomeprazole Magnesium

    115 1Esomeprazole Sodium

    116 1Ethinyl Estradiol

    117 1Etoricoxib

    118 3Etravirine

    119 4Ezetimibe

    120 1Famciclovir

    121 2Famotidine

    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 5Imatinib Mesylate

    144 1Indomethacin

    145 2Irbesartan

    146 2Irinotecan Hydrochloride

    147 1Iron Sucrose

    148 1Isotretinoin

    149 3Itraconazole

    150 1Ivabradine Hydrochloride

    151 1Ivacaftor

    152 1Lacosamide

    153 3Lamivudine

    154 4Lansoprazole

    155 1Lapatinib Ditosylate

    156 1Ledipasvir

    157 1Lenacapavir

    158 2Lenacapavir Sodium

    159 4Lenalidomide

    160 1Lenvatinib

    161 1Lenvatinib Mesylate

    162 1Lercanidipine

    163 2Lercanidipine Hydrochloride

    164 1Letrozole

    165 4Levetiracetam

    166 1Levodopa

    167 1Levofloxacin

    168 2Levofloxacin Hemihydrate

    169 1Levonorgestrel

    170 1Lidocaine Hydrochloride

    171 3Lisinopril

    172 3Lopinavir

    173 2Losartan Potassium

    174 3Lurasidone Hydrochloride

    175 2Maraviroc

    176 1Melphalan Hydrochloride

    177 12Memantine Hydrochloride

    178 1Metaxalone

    179 2Metoprolol Succinate

    180 1Mexiletine

    181 1Micafungin

    182 1Midostaurin

    183 1Milnacipran HCl

    184 1Milnacipran Hydrochloride

    185 2Mirabegron

    186 2Mirtazapine

    187 1Mitapivat

    188 1Montelukast Sodium

    189 2Moxifloxacin Hydrochloride

    190 1Nabumetone

    191 1Naproxen

    192 1Naproxen Sodium

    193 3Nebivolol

    194 2Nevirapine

    195 1Nilotinib

    196 1Nintedanib Esylate

    197 1Obeticholic Acid

    198 2Olanzapine

    199 1Olaparib

    200 2Olmesartan Medoxomil

    201 2Omeprazole

    202 1Omeprazole Magnesium

    203 1Opicapone

    204 3Oseltamivir Phosphate

    205 4Osimertinib Mesylate

    206 1Oxaliplatin

    207 1Paclitaxel

    208 1Palbociclib

    209 1Pantoprazole Magnesium

    210 2Pantoprazole Sodium

    211 1Pazopanib Hydrochloride

    212 1Pemetrexed Disodium

    213 1Perindopril Erbumine

    214 3Pioglitazone Hydrochloride

    215 1Pitavastatin

    216 1Plerixafor

    217 1Pomalidomide

    218 1Ponatinib

    219 1Pralatrexate

    220 2Pramipexole Dihydrochloride

    221 1Prasugrel Hydrochloride

    222 2Pregabalin

    223 1Progesterone

    224 1Proguanil

    225 5Quetiapine Hemifumarate

    226 1Rabeprazole Sodium

    227 1Raloxifene Hydrochloride

    228 3Raltegravir Potassium

    229 2Ramipril

    230 1Regorafenib

    231 1Relugolix

    232 1Rifaximin

    233 1Rilpivirine Hydrochloride

    234 1Riluzole

    235 1Rimegepant Sulfate

    236 2Risedronate Sodium

    237 4Ritonavir

    238 1Rivaroxaban

    239 1Rivastigmine

    240 1Rizatriptan Benzoate

    241 1Roflumilast

    242 3Rosuvastatin Calcium

    243 1Rufinamide

    244 1Rupatadine Fumarate

    245 2Saquinavir Mesylate

    246 1Saxagliptin Hydrochloride

    247 1Selenious Acid

    248 4Sertraline Hydrochloride

    249 2Sevelamer Carbonate

    250 1Sevelamer Hydrochloride

    251 2Sildenafil Citrate

    252 1Silodosin

    253 2Simvastatin

    254 1Sodium Zirconium Cyclosilicate

    255 1Sofosbuvir

    256 1Solifenacin Succinate

    257 1Solriamfetol Hydrochloride

    258 2Sorafenib

    259 1Sotorasib

    260 1Stavudine

    261 2Sunitinib

    262 2Telmisartan

    263 1Temozolomide

    264 3Tenofovir Alafenamide Fumarate

    265 2Tenofovir Disoproxil Fumarate

    266 2Terbinafine Hydrochloride

    267 1Testosterone

    268 1Tetrabenazine

    269 1Thalidomide

    270 1Tipiracil Hydrochloride

    271 1Tizanidine Hydrochloride

    272 1Tolterodine Tartrate

    273 2Tolvaptan

    274 2Topiramate

    275 1Torsemide

    276 1Trandolapril

    277 1Trifluridine

    278 1Trilaciclib Dihydrochloride

    279 2Valacyclovir Hydrochloride

    280 2Valganciclovir Hydrochloride

    281 4Valsartan

    282 2Varenicline Tartrate

    283 1Velpatasvir

    284 1Venetoclax

    285 1Venlafaxine Hydrochloride

    286 1Vericiguat

    287 2Vigabatrin

    288 1Vismodegib

    289 2Voriconazole

    290 2Vortioxetine Hydrobromide

    291 1Zafirlukast

    292 1Zanubrutinib

    293 2Zidovudine

    294 1Ziprasidone Hydrochloride

    295 2Zoledronic Acid

    296 1Zolmitriptan

    297 2Zonisamide

    298 4Blank

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    01

    Amlodipine Besylate

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

    PEGS Boston Summit
    Not Confirmed
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    Amlodipine Besylate

    India

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-27

    Pay. Date : 2012-12-17

    DMF Number : 18787

    Submission : 2005-09-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2025-407 - Rev 00

    Issue Date : 2025-12-04

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10106

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

    Initial Date of Registration : 2011-07-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Novartis Korea

    Registration Date : 2022-10-18

    Registration Number : 20120120-130-H-183-36(7)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana, India

     VMF Others AUDIT arrow-down
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    02

    Anastrozole

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

    PEGS Boston Summit
    Not Confirmed
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    Anastrozole

    India

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

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    PEGS Boston Summit
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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 : CEP 2013-172 - Rev 02

    Issue Date : 2025-10-17

    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 : 2025-09-03

    Valid Till : 2028-08-08

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Aripiprazole

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

    PEGS Boston Summit
    Not Confirmed
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    Aripiprazole

    India

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

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    PEGS Boston Summit
    Not Confirmed
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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 : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0020

    Start Marketing Date : 2002-11-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharma One Co., Ltd.

    Registration Date : 2026-02-11

    Registration Number : 20190314-209-J-189(5)

    Manufacturer Name : Hetero Labs Limited (Unit-I)

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

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    04

    Atomoxetine

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

    PEGS Boston Summit
    Not Confirmed
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    Atomoxetine

    India

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

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    PEGS Boston Summit
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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 : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 68554-0021

    Start Marketing Date : 2002-11-26

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Youngjin Pharmaceutical Co., Ltd.

    Registration Date : 2024-05-01

    Registration Number : Number 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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    05

    Atovaquone

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

    PEGS Boston Summit
    Not Confirmed
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    Atovaquone

    India

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

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    PEGS Boston Summit
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-15

    Pay. Date : 2013-02-26

    DMF Number : 24446

    Submission : 2010-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2025-001 - Rev 01

    Issue Date : 2026-04-23

    Type : Chemical

    Substance Number : 2192

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 307MF10070

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

    Initial Date of Registration : 2025-06-18

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0159

    Start Marketing Date : 1992-11-25

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Bicalutamide

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

    PEGS Boston Summit
    Not Confirmed
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    Bicalutamide

    India

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

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    PEGS Boston Summit
    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 : 2025-09-03

    Valid Till : 2028-08-08

    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    Capecitabine

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

    PEGS Boston Summit
    Not Confirmed
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    Capecitabine

    India

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

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    PEGS Boston Summit
    Not Confirmed
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    USDMF arrow-down
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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 05

    Issue Date : 2026-01-19

    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 : 2025-09-03

    Valid Till : 2028-08-08

    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 : 2026-12-31

    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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    08

    Donepezil

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

    PEGS Boston Summit
    Not Confirmed
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    Donepezil

    India

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

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    PEGS Boston Summit
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    • EDQM
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-10-26

    Pay. Date : 2012-11-29

    DMF Number : 21018

    Submission : 2007-11-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-301 - Rev 02

    Issue Date : 2024-08-01

    Type : Chemical

    Substance Number : 2582

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10202

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

    Initial Date of Registration : 2010-07-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0020

    Start Marketing Date : 1996-11-25

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2018-06-25

    Registration Number : 20120919-158-I-131-10(4)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy.No.213. 214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District-502313, Telangana State, India

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    09

    Duloxetine Hydrochloride

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

    PEGS Boston Summit
    Not Confirmed
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    Duloxetine Hydrochloride

    India

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

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    PEGS Boston Summit
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-24

    Pay. Date : 2013-09-23

    DMF Number : 25280

    Submission : 2011-09-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-305 - Rev 03

    Issue Date : 2025-08-20

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10022

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

    Initial Date of Registration : 2020-02-06

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-19

    Valid Till : 2028-07-03

    Written Confirmation Number : WC-0040

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65977-0035

    Start Marketing Date : 2004-08-03

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Myungin Pharmaceutical Co., Ltd.

    Registration Date : 2018-01-16

    Registration Number : Number 3838-4-ND(2)

    Manufacturer Name : Hetero Drugs Limited

    Manufacturer Address : Sy. No.213. 214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Telangana, India

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    Dutasteride

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

    PEGS Boston Summit
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    Dutasteride

    India

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

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    USDMF arrow-down
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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 : 2025-09-03

    Valid Till : 2028-08-08

    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 : 2026-12-31

    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 : Su473-21-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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    Contact Hetero Drugs and get a quotation

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