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list of Ready Dossiers

 



Sr. No Product Name Strength Region Format Module BE Study
1 Famotidine USP Tablets 20, 40 mg US eCTD M1,M2,M3 Available
2 Metronidazole Capsule USP 375 mg US CTD M1,M2,M3,M5 Original with data
3 Metronidazole Tablets USP 250, 500 mg US CTD M1,M2,M3,M5 Original with data
4 Metronidazole ER Tablets USP 750 mg US CTD M1,M2,M3,M5 Original with data
5 Fluoxetine Capsule USP 10, 20, 40 mg US CTD M1,M2,M3,M5 Original with data
6 Ropinirole Tablets USP 0.25, 0.5, 1, 2, 3, 4, 5 mg US CTD M1,M2,M3,M5 Original with data
7 Lamotrigine Tablets USP 25, 100, 150, 200 mg US CTD M1,M2,M3,M5 Original with data
8 Valsartan tablets USP 40, 80, 160, 320 mg US CTD M1,M2,M3,M5 Original with data
9 Lefunomide Tablets USP 10, 20 mg US CTD M1,M2,M3,M5 Original with data
10 Losartan Potassium & Hydrochlorothiazide Tablets USP 50/12.5, 100/12.5 & 100/25 US CTD M1,M2,M3,M5 Original with data
11 Rivastigmine Tartrate cap USP 1.5, 3, 4.5, 6 mg US CTD M1,M2,M3,M5 Original with data
12 Memantine HCl Tablets USP 10, 20 mg US CTD M1,M2,M3,M5 Original with data
13 Lamotrigine Tablets USP Dispercible Tablets 5, 25 mg US CTD M1,M2,M3,M5 Original with data
14 Zolmitriptan Tablets 2.5, 5 mg US CTD M1,M2,M3,M5 Original with data
15 Asenapine Sublingual Tablets 5, 10 mg US CTD M1,M2,M3,M5 Original with data
16 Nisoldipine ER Tablets 17.5, 25, 34 mg US CTD M1,M2,M3,M5 Original with data
17 Vardenafil HCl Orally Disintegrating Tablets 10 mg US CTD M1,M2,M3,M5 Original with data
18 Rivaroxaban Tablets 10 mg US CTD M1,M2,M3,M5 Original with data
19 Ticagrelor Tablets 90 mg US CTD M1,M2,M3,M5 Original with data
20 Fluoxetine Tablets USP 10, 30 mg US CTD M1,M2,M3,M5 Original with data
21 Fenofibric acid DR cap USP 45, 135 mg EU CTD M1,M2,M3,M5 Original with data
22 Pramipexole Prolonged release Tablets 0.26, 0.52, 1.05, 1.57, 2.1, 2.62, & 3.15 mg EU CTD M1,M2,M3,M5 Original with data
23 Olmesartan Medoxomil Tablets 10, 20, 40 mg EU CTD M1,M2,M3,M5 Original with data
24 Olmesartan & Hydrochlorothiazide Tablets 20/12.5. 20/25, 40/12.5, 40/25 EU CTD M1,M2,M3,M4,M5 Original with data
25 Duloxetine HCl DR Cap 30, 60 mg EU CTD M1,M2,M3,M4,M5 Original with data
26 Duloxetine HCl DR Cap 20, 40 mg EU CTD M1,M2,M3,M4,M5 Original with data
27 Tadalafil Tablets 5,10,20,25 mg EU CTD M1,M2,M3,M4,M5 Original with data
28 Celecoxib cap 100, 200 mg EU CTD M1,M2,M3,M5 Original with data
29 Olopatadine Ophthalmic solution USP 0.1 % 0.1 % EU CTD M1,M2,M3,M5 Original with data
30 Bosentan Tablets 62.5, 125 mg IH CTD M1,M2,M3,M5 Reference
31 Bupropion Tablets USP 75, 100 mg EU CTD M1,M2,M3,M5 Original with data
32 Bupropion Tablets USP (Modified Delayed Release) 150, 300 mg EU CTD M1,M2,M3,M5 Original with data
33 Candesartan Cilexetil Tablets 4,8,16,32 mg EU CTD M1,M2,M3,M5 Original with data
34 Pramipexole Tablets 0.088,0.18, 0.7 mg EU CTD M1,M2,M3,M5 Original with data
35 Etoricoxib Tablets 30,60,90,120 mg EU CTD M1,M2,M3,M4,M5 Original with data
36 Venlafaxine HCl Prolonged release Tablets 225 mg EU CTD M1,M2,M3,M4,M5 Original with data
37 Tadalafil Tablets 20 mg EU CTD M1,M2,M3,M4,M5 Original with data
38 Aripiprazole Tablets 5,10,20,30 mg EU CTD M1,M2,M3,M4,M5 Original with data
39 Amlodipine & Valsartan Tablets 5/160, 10/160 mg EU CTD M1,M2,M3,M4,M5 Original with data
40 Azithromycin Dispersible 100 mg Tablets 100 mg EU CTD M1,M2,M3,M4,M5 Original with data
41 Montelukast Sodium 10 mg Tablets 10 mg EU CTD M1,M2,M3,M4,M5 Original with data
42 Carboxy Methyl Cellulose Sodium Eye drops 0.5 % w/v EU CTD M1,M2,M3,M4,M5 Reference
43 Telmisartan 40 mg Tablets USP 40 mg EU CTD M1,M2,M3,M4,M5 Original with data
44 Telmisartan 80 mg Tablets USP 80 mg EU CTD M1,M2,M3,M4,M5 Original with data
45 Candesartan Cilexetil & Hydrochlorothiazide Tablets 16/12.5, 32/12.5, 32/25 EU CTD M1,M2,M3,M5 Original with data
46 Venlafaxine HCl Extended release cap 75, 150 mg EU CTD M1,M2,M3,M4,M5 Original with data
47 Acetylsalicylic acid 100 mg / Atorvastatin 20 mg / Ramipril 2.5/5/10 mg HardCapsule GCC CTD M1,M2,M3,M4,M5 Avilable
48 Aciclovir powder for soln for infusion 500, 250 mg EU CTD M1,M2,M3,M4,M5 Reference data
48 Acyclovir ointment 5 % USP ‘5 % US CTD M1,M2,M3,M4,M5 Reference data
49 Albumin Macro Aggregated inj 10ml TGA CTD M1,M2,M3,M4,M5
50 Alfacalcidol soft gel capsules 1, 0.5, 0.25 micro EU CTD M1,M2,M3,M4,M5 Avilable
51 Alfuzosin Prolonged release 10mg
52 Alizapride hydrochloride 50 m 2ml Ampule GCC Reference Data
53 Allopurinol 200 mg tablets 200 mg tablets EU Reference Data
54 Amantadine Hydrochloride Capsules USP, 100 mg US Available
54 Amantadine Hydrochloride Capsules USP, 100 mg US Available
55 Ambroxol Hcl Effervecent Tablet 60 mg EU Reference Data
56 Ambroxol Hcl Effervecent Tablet 10/320 mg, 5/320, 10/160, 5/160, 5/80, 5/160. US Available
57 Amlodipine 5mg 10mg Tablets 5mg 10mg Tablets EU Available
58 Amoxicillin Clavulanate Powder for inj 500 mg 100mg inj, 1000 mg 200mg inj EU Reference Data
59 Amoxicillin clavulanic acid potassium Tablet
60 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Black current Lozenges EU Reference Data
61 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Honeylemon Lozenges EU Reference Data
62 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Lemon Lozenges EU Reference Data
63 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Orange Lozenges EU Reference Data
64 Anastrozole Film Coated Tablet 1mg EU Avilable
65 Apixaban Tablet 2.5, 5mg 2.5, 5mg
66 Argatroban 100 mg/ml infusion 100 mg/ml infu EU Reference Data
67 Aripiprazole 10 mg 5 mg, 10 mg, 15, 20, 30 mg Tablet EU Avilable
68 Aripiprazole 1mg/ml oral solution EU
69 Asenapine Sublingul Tablets 10 mg 5mg. Avilable
70 Atenolol BP Tablet 100mg Malaysia Reference Data
71 Atorvastatin tablet 20mg Ethiopia Avilable
72 Atovaquone & Proguanil HCl Film-Coated Tablets 62.5mg/25mg & 250mg/100mg FCT Module 2, 3
73 Azithromycin 250mg Capsule 250mg Capsule EU Reference Data
74 Azithromycin Dispersible tablet 100mg Uganda
75 Baclofen Injection 0.05 mg, 0.5mg, 1 mg 2 mg 3 mg/ mltd EU Reference Data
76 Beclometasone nasal Spray 50 mic EU M1,M2,M3 Reference data
77 Bendamustine Hcl 2.5 mg/ml Powder for Injection 2.5 mg/ml (100 mg/vial) EU M1,M2,M3,M5 Reference data
78 Benfotiamine 300 mg film-coated tablet EU M1,M2,M3,M5 Not Applicable
79 Betahistine Tablet 16 mg, 8mg GCC M1,M2,M3,M5 Available
80 Betaxolol hydrochloridum Tablet 20 mg Tablet EU M1,M2,M3,M5 Available
81 Bicalutamide 150mg FCT 150 mg, 50mg EU M1,M2,M3,M5 Available
82 Bisoprolol Tablet Tablet EU M1,M2,M3,M5 Available
83 Bosentan FCT 125 mg, 62.5 mg EU M1,M2,M3,M5 Available
84 Botulinum Toxin Type A Lyopilized 50 U, 100 U Soln for inj EU M1,M2,M3,M5 Available
85 Brintellix Film-coated tablets 5 mg, 1 0 mg, 15 mg and 20 mg FCT EU M1,M2,M3,M5 Available
86 Buccal Oral Insulin Spray Inhalation ECC M1,M2,M3,M5 Reference Data
87 Budesonide Entric coated Tablet 3 mg US M1,M2,M3,M5 Avilable
88 Bupivacaine Solution for Injection 2.5 mg/ml, 5 mg/ml Injection
89 Buprenorphine Patches 5mcg/h 10mcg/h EU M1,M2,M3,M5 Available
90 Buprenorphine Hcl + Naloxone Hcl Sublingual 8mh/2mg, 2mg/0.5mg Tablet US M1,M2,M3,M5 Available
91 Bupropion Tablets USP 100 mg, 75mg EU M1,M2,M3,M5 Available
92 Bupropion Tablets USP (Modified Delayed Release) 300 mg, 150 mg US M1,M2,M3,M5 Available
93 Buspirone hydrochloride 5 mg, 10mg EU M1,M2,M3,M5 Reference data
94 Calcium folinate Powder Soln for Inj 200 Mg, 100mg EU M1,M2,M3,M5 Available
95 Calcium Levofolinate Soln for Inj 10 mg/ml EU M1,M2,M3,M5 Reference data
96 Candesartan Cilexetil & Hydrochlorothiazide 32/25 mg, 32/12.5 mg EU M1,M2,M3,M5 Available
97 Candesartan Cilexetil Tablet 32 mg, 16mg, 8mg, 4mg CA M1,M2,M3,M5 Available
98 Capecitabine Film-coated Tablets 500mg, 300mg, 100 mg EU M1,M2,M3,M5 Available
99 Capsicum 0.05% cream 0.05% cream EU M1,M2,M3,M4,M5 Reference Data
100 Carbamazepine USP 200mg Tablet 200mg Tablet US M1,M2,M3,M4,M5 Available
101 Carboxyl Nethyl Celulose Eye Drops 20.5 w/v M1,M2,M3,M4,M5 Mosambique
102 Carvidelol Tablet 12.5 mg , 25mg EU M1,M2,M3,M4,M5 Available
103 Caspofungin Acetate powder sol for info 70 mg, 50mg EU M1,M2,M3,M5 Reference Data
104 Cefazolin Injection 2 G, 1G EU M1,M2,M3,M5 Reference Data</td
105 Cefepime Hcl injection 1G, 2G Vail EU M1,M2,M3,M5 Reference Data
106 Cefotaxime injection 0.5G, 1G, 2G vail EU M1,M2,M3,M5 Reference Data
107 Ceftazidime inj 0.5, 1, 2g. EU M1,M2,M3,M5
108 Ceftriaxone 1G powder for Injection 2G, 1G, 500mg Injection EU M1,M2,M3,M5 Reference Data
109 Celecoxib cap 200 mg, 100 mg EU M1,M2,M3,M5 Available
110 Celecoxib cap 200 mg, US M1,M2,M3,M4,M5 Available
111 Celecoxib capsule 225 mg GCC M1,M2,M3,M4,M5 Available
112 CETIRIZINE 1mg/ml ORAL SOLUTION 1mg/ml ORAL SOLUTION EU M1,M2,M3,M4,M5 Reference Data
113 Cetirizine Dihydrochloride 10 mg Tablets EU M1,M2,M3,M4,M5 Available
114 Chlorohexidine, Benzocaine lozenges 5 mg/5mg EU M1,M2,M3,M4,M5 Reference Data
115 Chlorohexidine, Benzocaine Strong lozenges 5mg/5mgtd> EU M1,M2,M3,M4,M5 Reference Data
116 Chlorthalidone USP 25 mg Tablet 50mg,25 mg Tablet US M1,M2,M3,M4,M5 Reference Data
117 Cholecalciferol oral drops solution 10,000 IU/ml, 25,000 IU/2.5 ml oral solution oral drops solution EU M1,M2,M3,M4,M5 Reference Data
118 Cilnidipine Tablets 5mg Jordan M1,M2,M3,M4,M5 Reference Data
119 Cilnidipine Tablets 5 mg 5mg Tablets Philippines M1,M2,M3,M4,M5 Original with data
120 Cinacalcet Hydrochloride Tablets 90 mg, 60 mg, 30 mg US M1,M2,M3,M5 Available
121 Ciprofloxacin tablets USP 250 mg, 500mg Uganda M1,M2,M3,M4,M5
122 Cisatracurium soln for inj/info 20mg, 10mg, 5mg, 1mg/ml EU M1,M2,M3,M4,M5 Reference data
123 Citalopram 10mg, 20mg & 40mg Tablets 10mg, 20mg & 40mg Tablets EU M1,M2,M3,M4,M5 Available
125 Cladribine 1mg/ml EU M1,M2,M3,M4,M5 Reference data
126 Clarithromycin HEC 500 mg EU M1,M2,M3,M4,M5 Available
127 Clopidrogrel Tablet USP 75mg US CTD M1,M2,M3,M4,M5 Available
128 Colecalciferol 800 IU soft Cap 800 IU soft Cap EU Reference data
129 Colestyramine light powder 4g oral suspension EU Available
130 Cyamemazine 100mg 25 mg tablet 100mg 25 mg Tablet EU Available
131 Cyclofosfamide Sol for Injection 102g, 1g, 500 mg EU Reference data
132 Cytarabine 20 mgml 20 mg ml EU Reference data
133 DAP-Penicillin powder sol for inj 0.4mg/0.5mg EU Reference Data
134 Desflurane 100% Volatile liq for Inh. Inhalation EU
135 Desloratadine- Film-coated Tablets 5mg EU Available
134 Desogestrel and Ethinylestradiol tablets 150 micrograms and 20 micrograms EU Available
135 Desogestrel FCT 750MG EU Available
136 Desvenlafaxine Extended-Release Tablets 100 mg, 50mg US Available
137 Dexamethasone 4mg/ml 4mg/ml EU Reference Data
138 Dexketoprofen Injection 50 mg/2ml EU Reference Data
139 Dextromethorphan hydrobromide monohydrate 15 mg and 30 mg tablets EU Available
140 Diazepam 5 mg tablet 5 mg tablet EU Available
141 Diazepam 5 mg/ml solution for injection 5 mg/ml solution for injection EU Reference Data
142 Diclofenac Eye Drop 1mg/ml Singe use 0.5ml EU Reference Data
143 Diclofenac Sodium Gel 1% gel Myanmar Reference Data
144 Diclofenac Sodium injection 25 mg/ml Belarus Reference Data
145 dienogest 2.0 mg/ estradiol valerate 1.0 mgFCT 2.0 mg/1.0 mg FCT. EU Available
146 DIGEODREN Granules Granules EU Reference Data
147 Dipyridamol Modified release Cap Hard 200 mg EU Available
148 Disodium pamidronate inj 90mg, 60mg 30 mg EU Reference Data
149 ADocetaxel 20 mg/ml 20 mg/ml EU Reference Data
150 Donepezil hydrochloride Table 10 mg, 5mg CA Available
151 Drospirenone 3.0 mg/Ethinylestradiol 0.020mgFCT 3.0 mg/ 0.020 mg Film-coated tablets, 3.0 mg/ 0.030 mg EU Available
152 Duloxetine HCl DR Cap 60 mg, 40, 30, 20, mg EU Available
153 Duloxetine hcl Gastro resistant cap 60 mg, 30 mg EU
154 DUTASTERIDE 0.5 mg SOFT CAPSULES 0.5mg Soft Cap EU Available
155 Dutasteride soft capsule 0.5mg EU Available
156 Efavirenz Film coated Tab 600mg Fct EU Available
157 Emitricitabine and Tenofovir disoproxil 200mg/245mg Tablet EU Available
158 Enoxaparin Enoxaparin 150, 100 mg/ml EU Available
159 Enoxaparin 300 mg/3ml EU Available
160 Enoxaperine 6K 8K 10K, 4k,2k 10,000 IU EU Reference data
161 Epirubicin hydrochloride 2 mg/ml solution for injection EU Reference data
162 Eplerenone Film Coated Tablet 50 mg 25mg EU Available
163 Eptifibatide solution 2mg/ml, 0.75mg/ml EU Reference data
164 Erlotinib FCT 150 mg, 100mg, 25mg EU Reference data
165 Ertapenem Injection 1G injection EU Reference data
166 Escitalopram film coated Tablets 20, 15, 10, 5 mg EU Available
167 Esomeprazole Powder for sol inj/inf 40 mg EU Reference data
168 Etoposide 20 mg/ml 20 mg/ml EU Reference data
169 Etoricoxib film-coated tablets 120mg, 90, 60, 30 mg EU Available
170 Etoricoxib film-coated tablets* Etoricoxib film-coated tablets* EU Available
171 Everolimus 2.5 mg, 5 mg 10mg tablets EU Available
172 Exemestane FCT 25 mg EU Available
173 FAMCICLOVIR FILM-COATED TABLETS TABLETS 125mg/250mg/500mg/750mg EU Available
174 Famotidine USP Tablets 40 mg, 20mg US
175 Febuxostat Tablet 120 mg , 60mg EU Available
176 CFenofibrate Tablets, 54 160 mg USP 54 and 160 mg Tablets US Available
177 Fenofibric Acid Capsule 135mg 135 mg capsule EU Reference Data
178 CFenofibric acid DR cap USP 12135 mg, 45mg US Available
179 Fingolimod cap 0.5 mg EU M1,M2,M3,M5 Available
180 Flucloxacillin Powder for Solution for Injection 250 mg, 500mg, 1000 mg Injection EU M1,M2,M3,M5 Reference Data</td
181 Fluconazole infusion 100 mg per vail EU Reference Data
182 Fluconazole infusion Ethiopia Reference Data
183 Fluconazole soln for injection 100mg /50ml EU Reference Data
184 Flumazenil 0.1mgmL Solution 2G0.1mg/mL EU Reference Data
185 Fluorouracil Solution for Injection 50 mg/ml EU Reference Data
186 Fluoxetine capsule Hard 20 mg, EU Reference Data
187 Fluoxetine Tablets USP 30 mg, 10mg US Available
188 EFluticasone Propionate & Salmeterol CFC Free Inhaler 250/25 mic EU Available
189 Fosfomycin Trometamol 3 g granules 3 G oral solution EU Reference Data
190 Gabapentine 100mg cap 400mg, 300mg, 100mg cap EU Reference Data
191 Gadopentetate Dimeglumine injection 5mg/5mgtd> Malaysia Reference Data
192 Galantamine 4mg/ml oral solution 4mg/ml EU Reference Data
193 Ganciclovir 500mg 500mg EU Reference Data
194 Geftinib FCT 250 mg FCT EU Available
195 Gemcitabine 10 mgml 10 mg/ml EU Reference Data
196 Gemifloxacin 320 mg FCT 320 mg FCT GCC Available
197 Gliclazid sustain release 30mg EU Available
198 HeliCap 37 kBq, capsules 37 kBq Capsule EU Clinical Report
199 Heparin Solution for injection 5000 UI ml EU Reference data
200 Hydrocortisone powder for solution 250 mg, 100mg EU Reference data
201 Ibandronic Acid 3mg3ml 3mg/3ml/td> EU Reference data
202 Ibuprofen chewable soft gelatin capsules 100 mg 50 mg Soft Gel chewable EU Available
203 Ibuprofen Solution for Infusion 600mg/ 100ml EU Reference data
204 Ibuprofen 200 mg oral suspension Sachet 200 mg, 400mg EU Available
205 Ibuprofen 400 mg FCT Tablets 400 mg FCT, 600mg EU Available
206 Ibuprofen Lysine 342 mgFCT 684mg, 342 mg FCT EU Available
207 Ibuprofen Solution for Infusion 400mg/100ml EU Reference data
208 Ibuprofen/Paracetamol 200 mg/325 mg tablets 200 mg/325 mg tablets EU Reference Data
209 Imatinib Capsule 400 mg, 100 mg EU Available
210 Imatinib Tablet 100mg 400mg 100mg 400mg EU Available
211 Imipenem + Cilastatin Powder for Sol 500mg+ 500mg, 250mg + 250 mg EU Available
212 Iodixanol 320 mg I/ml Solution for injection 750MG EU Reference Data
213 Desvenlafaxine Extended-Release Tablets EU Reference Data
214 Iohexol Intravenous 300 Contras Media
215 Iopamidol Injection USP 300 370 mg EU Reference Data
216 Irbesartan Film Coated Tablet 300 mg, 150mg, 75mg EU Available
217 Irinotecan Hcl trihydrate Infusion 100mg/5ml EU Reference Data
218 Irinotecan Hcl trihydrate Infusion 40mg/2ml EU Reference Data
219 Irinotecan Hcl trihydrate Infusion 20mg/ml EU Reference Data
220 ISMIGEN 50mg Sublingual Tablet 1% gel GCC Available
221 Itraconazole Capsules 100 mg US Available
222 Ketamine hydrochloride Inj 50 mg/ml. EU
146 DIGEODREN Granules Granules EU Reference Data
223 Ketorolac Trometamol 10 mg/ml Solution for Injection 10 mg/mL EU Reference Data
224 Lacidipine FCT 2mg, 4mg, 6mg FC EU Available
225 Lamivudine Tablet 150mg US Available
226 Lamoterigine extended release tablet 50 mg EU Available
227 Lamotrigine Tablets USP 200 mg, 150mg, 100mg, 25mg US Available
228 Lefunomide Tablets USP 20 mg, 10mg US Available
229 Letrozole film coated 2.5mg EU Available
230 Levetiracetam Tablets 1000mg, 750mg, 500mg,250mg EU Available
231 Levobupivacaine soln for infusion 1.25 mg/ml EU Reference data
232 Levobupivacaine soln for infusion 7.5, 5, 2.5, 0.625 mg/ml EU Reference data
233 Levodopa/Carbidopa/Entacapone FCT 50+12.5+200 , 100+25+200, 150+37.5+200, 200+50+200 mg EU Available
234 Levofloxacin 5mg/ml soln for infu. 5mg/ml EU Reference data
235 Levofloxacin Film Coated Tablet 500 mg, 250 mg EU Available
236 Levonorgestrel Tablet 1.5mg 1.5 mg Tablet EU Available
237 Lidocaine 10mg/ml soln for infu. 50mg, 20 mg, 10mg/ml EU Reference data
238 Linezolid film tablet 600 mg EU Reference data
239 Linezolid sol for inj 2mg/ml EU Reference data
240 Linezolid Tablet 600 mg EU Available
241 Losartan Potassium & Hydrochlorothiazide Tablets USP US Available
242 Macrogol powder for oral solution 6.86 g/13.72 g EU Reference data
243 Megestrol acetate oral solution 40 mg/ml EU Available
244 Memantine film-coated tablets 20mg, 10 mg EU Reference data
245 Memantine HCl Tablets USP 20 mg, 10 mg US Available
246 Meprobamate Tablets USP 400 mg, 200 mg US Reference Data
247 Meropenem  powder for Sol 1000 mg Inj, 500 mg EU Reference data
248 Metformin FCT 1000mg, 850 mg, 500 mg EU Available
249 Methotrexate Oral Soln 2mg/ml Oral Solutin EU Available
250 Methylprednisolone powder sol for inj 125mg, 40mg EU Reference data

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