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    01 1Abacavir Sulfate

    02 1Abaloparatide

    03 1Abametapir

    04 1Abemaciclib

    05 2Acyclovir

    06 1Adefovir Dipivoxil

    07 1Adenine

    08 1Alendronate Sodium

    09 1Allopurinol

    10 1Almotriptan Malate

    11 1Alprazolam

    12 1Ambrisentan

    13 1Amiloride Hydrochloride

    14 3Amlodipine Besylate

    15 1Apalutamide

    16 1Apixaban

    17 1Apremilast

    18 2Aripiprazole

    19 1Armodafinil

    20 1Asenapine Maleate

    21 2Atazanavir Sulfate

    22 1Atenolol

    23 1Atomoxetine

    24 3Atorvastatin

    25 1Atovaquone

    26 1Atropine Sulfate

    27 1Avatrombopag Maleate

    28 1Azacitidine

    29 1Azathioprine

    30 1Azelastine Hydrochloride

    31 1Azilsartan Medoxomil Potassium

    32 1Azithromycin

    33 1Azithromycin Dihydrate

    34 1Baclofen

    35 1Baricitinib

    36 1Bedaquiline

    37 1Betrixaban Maleate

    38 1Bexarotene

    39 1Bicalutamide

    40 1Bictegravir Sodium

    41 1Bilastine

    42 1Blonanserin

    43 1Bortezomib

    44 1Bosentan Hydrate

    45 1Brexpiprazole

    46 1Brigatinib

    47 1Bromfenac Sodium

    48 1Busulfan

    49 2Canagliflozin

    50 1Candesartan Cilexetil

    51 1Capecitabine

    52 1Carfilzomib

    53 1Carvedilol

    54 1Carvedilol Phosphate

    55 1Celecoxib

    56 1Cetirizine

    57 2Cetirizine Dihydrochloride

    58 1Cevimeline Hydrochloride

    59 1Chlorthalidone

    60 1Ciprofloxacin

    61 2Ciprofloxacin Hydrochloride

    62 1Citalopram

    63 2Citalopram Hydrobromide

    64 3Clarithromycin

    65 1Clindamycin Palmitate

    66 1Clobetasone Butyrate

    67 1Clofarabine

    68 1Clopidogrel

    69 1Clozapine

    70 2Cobicistat

    71 1Colestipol

    72 1Dacarbazine

    73 1Daclatasvir

    74 1Darifenacin Hydrobromide

    75 2Darunavir

    76 1Darunavir Ethanolate

    77 1Dasatinib

    78 3Deferasirox

    79 1Desloratadine

    80 1Desmopressin Acetate

    81 1Desvenlafaxine Succinate

    82 1Deutetrabenazine

    83 2Dexlansoprazole

    84 1Dextromethorphan

    85 1Didanosine

    86 1Diflunisal

    87 1Dimethyl Fumarate

    88 1Diphenoxylate Hydrochloride

    89 1Dipyridamole

    90 1Disulfiram

    91 1Dofetilide

    92 2Dolutegravir Sodium

    93 1Doravirine

    94 1Doxazosin Mesylate

    95 1Dronedarone Hydrochloride

    96 1Droxidopa

    97 1Duloxetine Hydrochloride

    98 1Edoxaban Tosylate

    99 5Efavirenz

    100 1Efinaconazole

    101 2Eletriptan Hydrobromide

    102 2Elvitegravir

    103 1Empagliflozin

    104 3Emtricitabine

    105 1Enrofloxacin

    106 1Enzalutamide

    107 1Epinephrine

    108 1Epinephrine Bitartrate

    109 1Eprosartan

    110 1Eprosartan Mesylate

    111 2Erlotinib Hydrochloride

    112 1Escitalopram Oxalate

    113 3Esomeprazole Magnesium

    114 1Eszopiclone

    115 1Ethacrynic Acid

    116 1Etoricoxib

    117 1Etravirine

    118 1Exemestane

    119 1Ezetimibe

    120 1Febantel

    121 1Febuxostat

    122 2Felbamate

    123 1Ferric Carboxymaltose

    124 1Fexofenadine Hydrochloride

    125 1Fingolimod Hydrochloride

    126 1Fluconazole

    127 1Fludrocortisone Acetate

    128 1Fluocytosine

    129 1Fluticasone Propionate

    130 1Fomepizole

    131 1Fondaparinux Sodium

    132 1Formoterol Fumarate

    133 1Fosamprenavir

    134 1Frovatriptan

    135 1Frovatriptan Succinate Hydrate

    136 1Gabapentin

    137 1Garenoxacin

    138 1Gatifloxacin

    139 1Gemcitabine

    140 1Ibandronate Sodium

    141 1Ibrutinib

    142 1Icatibant Acetate

    143 1Idelalisib

    144 1Iloperidone

    145 1Imatinib Mesylate

    146 1Indinavir

    147 1Irbesartan

    148 1Iron Dextran

    149 2Iron Sucrose

    150 1Isosulfan Blue

    151 1Itraconazole

    152 1Labetalol Hydrochloride

    153 3Lamivudine

    154 1Lamotrigine

    155 1Lanreotide Acetate

    156 1Lansoprazole

    157 2Lanthanum Carbonate

    158 1Larotrectinib

    159 1Latanoprost

    160 1Ledipasvir

    161 1Lenalidomide

    162 1Letrozole

    163 1Leuprolide Acetate

    164 1Levetiracetam

    165 1Levofloxacin

    166 1Linaclotide

    167 1Linagliptin

    168 1Linezolid

    169 1Liraglutide

    170 1Lisinopril

    171 2Lopinavir

    172 2Loratadine

    173 1Losartan Potassium

    174 1Lumacaftor

    175 1Lurasidone Hydrochloride

    176 1Macitentan

    177 2Mafenide

    178 1Maraviroc

    179 1Memantine Hydrochloride

    180 1Mesalazine

    181 1Miglustat

    182 1Milnacipran Hydrochloride

    183 2Mirtazapine

    184 1Modafinil

    185 1Molindone

    186 1Montelukast Sodium

    187 1Moxifloxacin Hydrochloride

    188 1Nabumetone

    189 1Nadolol

    190 1Naproxen

    191 1Naproxen Sodium

    192 1Nelfinavir Mesylate

    193 2Nepafenac

    194 1Netupitant

    195 3Nevirapine

    196 1Nifedipine

    197 1Nintedanib Esylate

    198 1Nitrofurantoin

    199 1Octreotide Acetate

    200 1Olanzapine

    201 1Olmesartan Medoxomil

    202 1Olsalazine

    203 1Omeprazole Magnesium

    204 1Oseltamivir Phosphate

    205 1Osimertinib Mesylate

    206 1Oxybutynin Hydrochloride

    207 1Ozanimod

    208 1Palbociclib

    209 1Paliperidone

    210 2Paliperidone Palmitate

    211 2Pantoprazole Sodium

    212 1Parecoxib Sodium

    213 2Paroxetine Hydrochloride

    214 1Pemetrexed Disodium

    215 1Penciclovir

    216 1Pentosan Polysulfate Sodium

    217 1Pentostatin

    218 1Perindopril Erbumine

    219 1Phenoxybenzamine HCl

    220 1Phentolamine Mesylate

    221 1Pioglitazone Hydrochloride

    222 1Pirfenidone

    223 1Pitavastatin

    224 1Plecanatide

    225 1Plerixafor

    226 2Pomalidomide

    227 1Ponatinib

    228 1Pramipexole Dihydrochloride

    229 2Prasugrel

    230 1Prasugrel Hydrochloride

    231 3Pregabalin

    232 1Pretomanid

    233 1Primaquine Diphosphate

    234 1Procarbazine Hydrochloride

    235 1Proguanil

    236 1Propafenone Hydrochloride

    237 1Pyrazinamide

    238 1Quetiapine Hemifumarate

    239 1Quinapril

    240 1Rabeprazole Sodium

    241 2Raltegravir Potassium

    242 1Rasagiline Mesylate

    243 1Regadenoson Monohydrate

    244 1Regorafenib

    245 1Ribociclib

    246 1Rilpivirine Hydrochloride

    247 1Risedronate Sodium

    248 2Risperidone

    249 2Ritonavir

    250 1Rivaroxaban

    251 2Rivastigmine

    252 1Rivastigmine Tartrate

    253 1Rizatriptan Benzoate

    254 1Roflumilast

    255 1Romidepsin

    256 1Rosiglitazone

    257 1Rosuvastatin Calcium

    258 1Rotigotine

    259 1Roxadustat

    260 1Rucaparib Camsylate

    261 2Sacubitril Sodium

    262 1Sacubitril-Valsartan

    263 1Safinamide Methanesulfonate

    264 1Salmeterol Xinafoate

    265 1Saxagliptin

    266 1Saxagliptin Hydrochloride

    267 1Selegiline Hydrochloride

    268 1Selexipag

    269 1Semaglutide

    270 1Sertraline Hydrochloride

    271 1Sevelamer Carbonate

    272 1Sevelamer Hydrochloride

    273 1Sibutramine Hydrochloride

    274 2Sildenafil Citrate

    275 1Simvastatin

    276 1Sincalide

    277 1Sitagliptin Hydrochloride

    278 1Sitagliptin Phosphate

    279 1Sodium Nitroprusside

    280 1Sodium ferric gluconate

    281 1Sofosbuvir

    282 1Sotagliflozin

    283 3Stavudine

    284 1Sugammadex Sodium

    285 1Sumatriptan

    286 1Sunitinib

    287 1Suvorexant

    288 2Tadalafil

    289 1Telbivudine

    290 1Telmisartan

    291 1Temazepam

    292 2Tenofovir Alafenamide Fumarate

    293 2Tenofovir Disoproxil Fumarate

    294 1Terbinafine Hydrochloride

    295 2Tetrabenazine

    296 1Thalidomide

    297 1Thiotepa

    298 1Tiaprofenic Acid

    299 1Ticagrelor

    300 1Tizanidine Hydrochloride

    301 1Tofacitinib Citrate

    302 1Tolmetin Sodium

    303 2Tolterodine Tartrate

    304 1Trametinib

    305 1Trazodone Hydrochloride

    306 1Treprostinil Diolamine

    307 1Trientine Hydrochloride

    308 1Trifluridine

    309 1Upadacitinib

    310 1Vadadustat

    311 3Valacyclovir Hydrochloride

    312 1Valbenazine Tosylate

    313 2Valganciclovir Hydrochloride

    314 1Valsartan

    315 1Vardenafil Hydrochloride

    316 1Varenicline Tartrate

    317 1Velpatasvir

    318 1Venetoclax

    319 1Venlafaxine Hydrochloride

    320 1Verapamil Hydrochloride

    321 1Vilazodone Hydrochloride

    322 1Vildagliptin

    323 1Vonoprazan Fumarate

    324 1Voriconazole

    325 1Vorinostat

    326 1Vortioxetine Hydrobromide

    327 3Zidovudine

    328 1Zileuton

    329 1Zofenopril Calcium

    330 1Zoledronic Acid

    331 1Zolmitriptan

    332 1Zolpidem Tartrate

    333 1Zonisamide

    334 4Blank

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    01

    Lanthanum Carbonate

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

    Bioprocess International Europe
    Not Confirmed
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    Lanthanum Carbonate

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21958

    Submission : 2008-09-05

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10230

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2016-12-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    02

    Sildenafil Citrate

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

    Bioprocess International Europe
    Not Confirmed
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    Sildenafil Citrate

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-10-20

    Pay. Date : 2025-10-14

    DMF Number : 19097

    Submission : 2006-01-10

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 224MF10197

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2012-09-11

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2020-10-08

    Registration Number : 20200602-209-J-644(1)

    Manufacturer Name : Tianish Laboratories Private Limited (Unit-9)

    Manufacturer Address : Plot No. 5, Road No. 12, Tadi(V) JNPharma City, Parawada(M), Visakhapatnam District Andrea Pradesh, India

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    03

    Valsartan

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

    Bioprocess International Europe
    Not Confirmed
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    Valsartan

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-11

    Pay. Date : 2013-06-26

    DMF Number : 18253

    Submission : 2005-04-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF10153

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2014-09-01

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    04

    Ritonavir

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

    Bioprocess International Europe
    Not Confirmed
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    Ritonavir

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-30

    DMF Number : 19800

    Submission : 2006-09-26

    Status : Active

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2014-209 - Rev 00

    Issue Date : 2015-11-12

    Type : Chemical

    Substance Number : 2136

    Status : Withdrawn by Holder

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    05

    Abacavir Sulfate

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

    Bioprocess International Europe
    Not Confirmed
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    Abacavir Sulfate

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-11

    DMF Number : 18229

    Submission : 2005-03-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

    Address of the Firm :

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    06

    Acyclovir

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

    Bioprocess International Europe
    Not Confirmed
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    Acyclovir

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-12-26

    Pay. Date : 2012-11-19

    DMF Number : 13277

    Submission : 1998-10-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10974

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2006-12-01

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Bukwang Pharmaceutical Co., Ltd.

    Registration Date : 2018-05-04

    Registration Number : 20050831-33-A-83-09(3)

    Manufacturer Name : Mylan Laboratories Limited

    Manufacturer Address : 14, 99 & 100, Industrial Development Area Pashamylaram, Phase-II, Patancheru, 502 307, Medak District, Telangana, India

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    07

    Alendronate Sodium

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

    Bioprocess International Europe
    Not Confirmed
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    Alendronate Sodium

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20402

    Submission : 2007-04-02

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 220MF10178

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2008-07-31

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    08

    Allopurinol

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

    Bioprocess International Europe
    Not Confirmed
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    Allopurinol

    U.S.A

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

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    Bioprocess International Europe
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16409

    Submission : 2003-04-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10578

    Registrant's Address : Plot No. 14, 99 and 100, IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District - 502307, Telangana, India

    Initial Date of Registration : 2005-09-14

    Latest Date of Registration :

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    09

    Ambrisentan

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

    Bioprocess International Europe
    Not Confirmed
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    Ambrisentan

    U.S.A

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-10-20

    Pay. Date : 2014-04-15

    DMF Number : 24505

    Submission : 2010-12-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2023-05-10

    Valid Till : 2026-05-10

    Written Confirmation Number : WC-0015

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    Atazanavir Sulfate

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

    Bioprocess International Europe
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    Atazanavir Sulfate

    U.S.A

    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 : 20419

    Submission : 2007-03-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2023-05-10

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