Enquiry/Quote

Available CTD Dossier List

March 22, 2022

Sr. No Product Name Strength BE Study Region
1 Acetylsalicylic acid 100 mg / Atorvastatin 20 mg / Ramipril 2.5/5/10 mg HardCapsule Avilable GCC
2 Aciclovir powder for soln for infusion 500, 250 mg Reference data EU
3 Acyclovir ointment 5 % USP 5 % Reference data US
4 Albumin Macro Aggregated inj 10ml   TGA
5 Alfacalcidol soft gel capsules 1, 0.5, 0.25 micro Avilable EU
6 Alfuzosin Prolonged release 10mg    
7 Alizapride hydrochloride 50 mg 2ml Ampule Reference Data GCC
8 Allopurinol 200 mg tablets 200 mg tablets Available EU
9 Amantadine Hydrochloride Capsules USP, 100 mg Available US
10 Ambroxol Hcl Effervecent Tablet 60 mg Reference data EU
11 Amlodipine & Valsartan Tablets 10/320 mg, 5/320, 10/160, 5/160, 5/80, 5/160. Available US
12 Amlodipine 5mg 10mg Tablets 5mg 10mg Tablets Available EU
13 Amoxicillin Clavulanate Powder for inj 500 mg 100mg inj, 1000 mg 200mg inj Reference data EU
14 Amoxicillin clavulanic acid potassium Tablet    
15 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Black current Lozenges Reference Data EU
16 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Honeylemon Lozenges Reference Data EU
17 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Lemon Lozenges Reference Data EU
18 Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Orange Lozenges Reference Data EU
19 Anastrozole Film Coated Tablet 1mg Avilable EU
20 Apixaban Tablet 2.5, 5mg 2.5, 5mg    
21 Argatroban 100 mg/ml infusion 100 mg/ml infu Reference data EU
22 Aripiprazole 10 mg 5 mg, 10 mg, 15, 20, 30 mg Tablet Avialable EU
23 Aripiprazole 1mg/ml oral solution     EU
24 Asenapine Sublingul Tablets 10 mg 5mg. Available US
25 Atenolol BP Tablet 100mg Reference Data Malaysia
26 Atorvastatin tablet 20 mg Avilable Ethiopia
27 Atovaquone & Proguanil HCl Film-Coated Tablets 62.5mg/25mg & 250mg/100mg FCT Module 2, 3  
28 Azithromycin 250mg Capsule 250mg Capsule Reference Data EU
29 Azithromycin Dispersible tablet 100 mg   Uganda
30 Baclofen Injection 0.05 mg, 0.5mg, 1 mg 2 mg 3 mg/ ml Reference Data EU
31 Beclometasone nasal Spray 50 mic Reference data EU
32 Bendamustine Hcl 2.5 mg/ml Powder for Injection 2.5 mg/ml (100 mg/vial) Reference Data EU
33 Benfotiamine 300 mg film-coated tablet Not Applicable EU
34 Betahistine Tablet 16 mg, 8mg Avilable GCC
35 Betaxolol hydrochloridum Tablet 20 mg Tablet Available EU
36 Bicalutamide 150mg FCT 150 mg, 50mg Avilable EU
37 Bisoprolol Tablet Tablet Available EU
38 Bosentan FCT 125 mg, 62.5 mg Avilable EU
39 Botulinum Toxin Type A Lyopilized 50 U, 100 U Soln for inj Available EU
40 Brintellix Film-coated tablets 5 mg, 1 0 mg, 15 mg and 20 mg FCT Available EU
41 Buccal Oral Insulin Spray Inhalation Reference Data GCC
42 Budesonide Entric coated Tablet 3 mg Avilable US
43 Bupivacaine Solution for Injection 2.5 mg/ml, 5 mg/ml Injection    
44 Buprenorphine Patches 5mcg/h 10mcg/h Available EU
45 Buprenorphine Hcl + Naloxone Hcl Sublingual 8mh/2mg, 2mg/0.5mg Tablet Avilable US
46 Bupropion Tablets USP 100 mg, 75mg Available EU
47 Bupropion Tablets USP (Modified Delayed Release) 300 mg, 150 mg Available US
48 Buspirone hydrochloride 5 mg, 10mg Reference data EU
49 Calcium folinate Powder Soln for Inj 200 Mg, 100mg Avilable EU
50 Calcium Levofolinate Soln for Inj 10 mg/ml Reference data EU
51 Candesartan Cilexetil & Hydrochlorothiazide 32/25 mg, 32/12.5 mg, Available EU
52 Candesartan Cilexetil Tablets 32 mg, 16mg, 8mg, 4mg Available CA
53 Capecitabine Film-coated Tablets 500mg, 300mg, 100 mg Avilable EU
54 Capsicum 0.05% cream 0.05% cream Reference Data EU
55 Carbamazepine USP 200mg Tablet 200mg Tablet Avilable US
56 Carboxyl Nethyl Celulose Eye Drops 0.5 w/v   Mosambique
57 Carvidelol Tablet 12.5 mg , 25mg Avilable EU
58 Caspofungin Acetate powder sol for inf 70 mg, 50mg Reference Data EU
59 Cefazolin Injection 2 G, 1G Reference Data EU
60 Cefepime Hcl injection 1G, 2G Vail Reference Data EU
61 Cefotaxime injection 0.5G, 1G, 2G vail Reference Data EU
62 Ceftazidime inj 0.5, 1, 2g.   EU
63 Ceftriaxone 1G powder for Injection 2G, 1G, 500mg Injection Reference data EU
64 Celecoxib cap 200 mg, 100 mg Available EU
65 Celecoxib Cap 200mg Available US
66 Celecoxib capsule 200mg Avilable GCC
67 CETIRIZINE 1mg/ml ORAL SOLUTION 1mg/ml ORAL SOLUTION Reference Data EU
68 Cetirizine Dihydrochloride 10 mg Tablets Avilable EU
69 Chlorohexidine, Benzocaine lozenges 5 mg/5mg Reference data EU
70 Chlorohexidine, Benzocaine Strong lozenges 5mg/5mg Reference data EU
71 Chlorthalidone USP 25 mg Tablet 50mg,25 mg Tablet Avilable US
72 Cholecalciferol oral drops solution 10,000 IU/ml, 25,000 IU/2.5 ml oral solution oral drops solution Reference Data EU
73 Cilnidipine Tablets 5mg Reference Data Jordan
74 Cilnidipine Tablets 5 mg 5mg Tablets   Philippines
75 Cinacalcet Hydrochloride Tablets 90 mg, 60 mg, 30 mg  Avilable US
76 Ciprofloxacin tablets USP 250 mg, 500mg   Uganda
77 Cisatracurium soln for inj/inf 20mg, 10mg, 5mg, 1mg/ml Reference data EU
78 Citalopram 10mg, 20mg & 40mg Tablets 10mg, 20mg & 40mg Tablets Avilable EU
79 Cladribine 1mg/ml Reference data EU
80 Clarithromycin HEC 500 mg Avilable EU
81 Clopidrogrel Tablet USP 75mg Avilable US
82 Colecalciferol 800 IU soft Cap 800 IU soft Cap Reference data EU
83 Colestyramine light powder 4g oral suspension Available EU
84 Cyamemazine 100mg 25 mg tablet 100mg 25 mg Tablet Avilable EU
85 Cyclofosfamide Sol for Injection 2g, 1g, 500 mg Reference data EU
86 Cytarabine 20 mgml 20 mg ml Reference data EU
87 DAP-Penicillin powder sol for inj 0.4mg/0.5mg Reference data EU
88 Desflurane 100% Volatile liq for Inh. Inhalation   EU
89 Desloratadine- Film-coated Tablets 5 mg Avilable EU
90 Desogestrel and Ethinylestradiol tablets 150 micrograms and 20 micrograms Available EU
91 Desogestrel FCT 750 mcg Available EU
92 Desvenlafaxine Extended-Release Tablets 100 mg, 50mg Available US
93 Dexamethasone 4mg/ml 4mg/ml Reference data EU
94 Dexketoprofen Injection 50 mg/2ml Reference Data EU
95 Dextromethorphan hydrobromide monohydrate 15 mg and 30 mg tablets Avilable EU
96 Diazepam 5 mg tablet 5 mg tablet Avilable EU
97 Diazepam 5 mg/ml solution for injection 5 mg/ml solution for injection Reference Data EU
98 Diclofenac Eye Drop 1mg/ml Singe use 0.5ml   Reference Data EU
99 Diclofenac Sodium Gel 1% gel Reference Data Myanmar
100 Diclofenac Sodium injection 25 mg/ml Reference Data Belarus
101 dienogest 2.0 mg/ estradiol valerate 1.0 mgFCT 2.0 mg/1.0 mg FCT Available EU
102 DIGEODREN Granules Granules Reference Data EU
103 Dipyridamol Modified release Cap Hard 200 mg Avilable EU
104 Disodium pamidronate inj 90mg, 60mg 30 mg Referece Data EU
105 Docetaxel 20 mg/ml 20 mg/ml Reference data EU
106 Donepezil hydrochloride Tablet 10 mg, 5mg Avilable CA
107 Drospirenone 3.0 mg/Ethinylestradiol 0.020mgFCT 3.0 mg/ 0.020 mg Film-coated tablets, 3.0 mg/ 0.030 mg Avialable EU
108 Duloxetine HCl DR Cap 60 mg, 40, 30, 20, mg Available EU
109 Duloxetine hcl Gastro resistant cap 60 mg, 30 mg   EU
110 DUTASTERIDE 0.5 mg SOFT CAPSULES 0.5mg Soft Cap Available EU
111 Dutasteride soft capsules 0.5mg Avilable EU
112 Efavirenz Film coated Tab 600mg Fct Avilable EU
113 Emitricitabine and Tenofovir disoproxil 200mg/245mg Tablet Available EU
114 Enoxaparin 150, 100 mg/ml Avilable EU
115 Enoxaparine 300 mg/3ml Avilable EU
116 Enoxaperine 6K 8K 10K, 4k,2k 10,000 IU Reference data EU
117 Epirubicin hydrochloride 2 mg/ml solution for injection Reference Data EU
118 Eplerenone Film Coated Tablet 50 mg 25mg Avilable EU
119 Eptifibatide solution 2mg/ml, 0.75mg/ml Reference data EU
120 Erlotinib FCT 150 mg, 100mg, 25mg Reference data EU
121 Ertapenem Injection 1G injection Reference EU
122 Escitalopram film coated Tablets 20, 15, 10, 5 mg Avilable EU
123 Esomeprazole Powder for sol inj/infu 40 mg Reference data EU
124 Etoposide 20 mg/ml 20 mg/ml Reference data EU
125 Etoricoxib film-coated tablets 120mg, 90, 60, 30 mg Avilable EU
126 Etoricoxib film-coated tablets* 60, 90, 120 mg* Avilable EU*
127 Everolimus 2.5 mg, 5 mg 10mg tablets   Available EU
128 Exemestane FCT 25 mg Avilable EU
129 FAMCICLOVIR FILM-COATED TABLETS TABLETS 125mg/250mg/500mg/750mg Avilable EU
130 Famotidine USP Tablets 40 mg, 20mg   US
131 Febuxostat Tablet 120 mg , 60mg Available EU
132 Fenofibrate Tablets, 54 160 mg USP 54 and 160 mg Tablets Available US
133 Fenofibric Acid Capsule 135mg 135 mg capsule Reference EU
134 Fenofibric acid DR cap USP 135 mg, 45mg Available US
135 Fingolimod cap 0.5 mg Available EU
136 Flucloxacillin Powder for Solution for Injection 250 mg, 500mg, 1000 mg Injection Reference Data EU
137 Fluconazole infusion 100 mg per vail Referece Data EU
138 Fluconazole injection   Reference Data Ethiopia
139 Fluconazole soln for injection 100mg /50ml Reference Data EU
140 Flumazenil 0.1mgmL Solution 0.1mg/mL Reference data EU
141 Fluorouracil Solution for Injection 50 mg/ml Reference data EU
142 Fluoxetine capsule Hard 20 mg Reference data EU
143 Fluoxetine Tablets USP 30 mg, 10mg Available US
144 Fluticasone Propionate & Salmeterol CFC Free Inhaler 250/25 mic Avilable EU
145 Fosfomycin Trometamol 3 g granules 3 G oral solution Reference Data EU
146 Gabapentine 100mg cap 400mg, 300mg, 100mg cap Avilable EU
147 Gadopentetate Dimeglumine injection   Reference Data Malaysia
148 Galantamine 4mg/ml oral solution. 4mg/ml Reference Data EU
149 Ganciclovir 500mg 500mg Reference data EU
150 Geftinib FCT 250 mg FCT Avilable EU
151 Gemcitabine 10 mgml 10 mg/ml Reference data EU
152 Gemifloxacin 320 mg FCT 320 mg FCT Avilable GCC
153 Gliclazid sustain release 30mg Avilable EU
154 HeliCap 37 kBq, capsules 37 kBq Capsule Clinical Report EU
155 Heparin Solution for injection 5000 UI ml Refeference data EU
156 Hydrocortisone powder for solution 250 mg, 100mg Reference Data EU
157 Ibandronic Acid 3mg3ml 3mg/3ml Reference data EU
158 Ibuprofen chewable soft gelatin capsules 100 mg 50 mg Soft Gel chewable Available EU
159 Ibuprofen Solution for Infusion 600mg/ 100ml Reference data EU
160 Ibuprofen 200 mg oral suspension Sachet 200 mg, 400mg Avilable EU
161 Ibuprofen 400 mg FCT Tablets 400 mg FCT, 600mg Avilable EU
162 Ibuprofen Lysine 342 mgFCT 684mg, 342 mg FCT Available EU
163 Ibuprofen Solution for Infusion 400mg/100ml Reference data EU
164 Ibuprofen/Paracetamol 200 mg/325 mg tablets 200 mg/325 mg tablets Reference Data EU
165 Imatinib Capsule 400 mg, 100 mg Avilable EU
166 Imatinib Tablet 100mg 400mg 100mg 400mg Avilable EU
167 Imipenem + Cilastatin Powder for Sol 500mg+ 500mg, 250mg + 250 mg Reference data EU
168 Iodixanol 320 mg I/ml Solution for injection   Reference Data EU
169 Iohexol Intravenous 300 Contras Media    
170 Iopamidol Injection USP 300 370 mg Reference Data EU
171 Irbesartan Film Coated Tablet 300 mg, 150mg, 75mg Avilable EU
172 Irinotecan Hcl trihydrate Infusion 100mg/5ml Reference data EU
173 Irinotecan Hcl trihydrate Infusion 40mg/2ml Reference data EU
174 Irinotecan Hcl trihydrate Infusion 20mg/ml Reference data EU
175 ISMIGEN 50mg Sublingual Tablet   Available GCC
176 Itraconazole Capsules 100 mg Available US
177 Ketamine hydrochloride Inj 50 mg/ml    
178 Ketorolac Trometamol 10 mg/ml Solution for Injection 10 mg/mL Reference Data EU
179 Lacidipine FCT 2mg, 4mg, 6mg FCT Available EU
180 Lamivudine Tablet 150mg Avilable US
181 Lamoterigine extended release tablet 50 mg Avilable EU
182 Lamotrigine Tablets USP 200 mg, 150mg, 100mg, 25mg Available US
183 Lefunomide Tablets USP 20 mg, 10mg Available US
184 Letrozole film coated 2.5mg Avilable EU
185 Levetiracetam Tablets 1000mg, 750mg, 500mg,250mg Avilable EU
186 Levobupivacaine soln for infusion 1.25 mg/ml Reference data EU
187 Levobupivacaine soln for infusion 7.5, 5, 2.5, 0.625 mg/ml Reference data EU
188 Levodopa/Carbidopa/Entacapone FCT 50+12.5+200 , 100+25+200, 150+37.5+200, 200+50+200 mg Avilable EU
189 Levofloxacin 5mg/ml soln for infu. 5mg/ml Reference data EU
190 Levofloxacin Film Coated Tablet 500 mg, 250 mg Avilable EU
191 Levonorgestrel Tablet 1.5mg 1.5 mg Tablet Available EU
192 Lidocaine 10mg/ml soln for infu. 50mg, 20 mg, 10mg/ml Reference data EU
193 Linezolid film tablet 600 mg Reference data EU
194 Linezolid sol for inj 2mg/ml Reference data EU
195 Linezolid Tablet 600 mg Available EU
196 Losartan Potassium & Hydrochlorothiazide Tablets USP 100/25 mg, 100/12.5, 50/12.5 mg Available US
197 Macrogol powder for oral solution 6.86 g/13.72 g Reference data EU
198 Megestrol acetate oral solution 40mg/ml Avilable EU
199 Memantine film-coated tablets 20mg, 10 mg Reference data EU
200 Memantine HCl Tablets USP 20 mg, 10 mg Available US
201 Meprobamate Tablets USP 400 mg, 200 mg Reference Data US
202 Meropenem  powder for Sol 1000 mg Inj, 500 mg Reference data EU
203 Metformin FCT 1000mg, 850 mg, 500 mg Avilable EU
204 Methotrexate Oral Soln 2mg/ml Oral Solutin Avilable EU
205 Methylprednisolone powder sol for inj 125mg, 40mg Reference data EU
206 Metoprolol tartrate 100mg 50mg Tablet 100 mg 50mg tablet Available EU
207 Metoprolol tartrate SR 200 mg 200mg SR Tablet Avilable EU
208 Metoprolol tratarate & Hydrochlorothiazide 100/50 mg, 100/25, 50/25 mg Available EU
209 Metronidazole Gel   Reference Data Ethiopia
210 Metronidazole 5 mg/ml Solution for Infusion 5 mg/ml Solution for Infusion Module 1 2 3 EU
211 Metronidazole Capsule USP 375 mg Available US
212 Metronidazole Dental Gel   Reference Data Ethiopia
213 Metronidazole Tablets USP 500 mg, 250 mg Available US
214 Metronidazole-gel Gel   Ethiopia
215 Mitomycin Solution for Injection 40mg/ml Reference data EU
216 Mitoxantrone Concentrate Sol for Infu 2 mg/ml Reference data EU
217 Mitoxantrone hydrochloride Conc Sol inj 2 mg/ml Reference data EU
218 Modafinil Tablets USP 200mg, 100 mg Available US
219 Montelukast 10 mg tablet Avilable US
220 Montelukast Sodium Chewable tab 10 mg   Tanzania
221 Moxifloxacin FCT 400mg Avilable GCC
222 Mycophenolic Acid Tablets 360 mg Avilable US
223 Nebivolol Tablets 20 mg, 10mg, 5mg, 2.5 mg Reference Data Mayanmar
224 Nicorandil Tablet 20mg, 10mg Avilable EU
225 Nicotin Chewing gum      
226 Nisoldipine ER Tablets 34 mg, 25mg, 17.5mg,8.5mg Available US
227 Nitisinone Capsule 2mg, 5mg, 10mg cap Avilable (M1 M3 M5) US
228 Ofloxacin eye drops, solution 3mg/ml Reference data EU
229 Ofloxacin 0.5 ml single dose 0.5 ml Reference data EU
230 Olanzapine Film Coated Tablet 10 mg, 5mg Avilable EU
231 Olmesartan & Hydrochlorothiazide Tablets 40/25 mg, 40/12.5, 20/25, 20/12.5 mg Available US
232 Olmesartan Medoxomil Tablets 40 mg, 20mg, 10mg Available EU
233 Olopatadine Ophthalmic solution USP 0.1 % 0.1 % Refercee Data US
234 Omega-3-Acid Ethyl Esters 90 Momaja 1000mg Soft Gel Capsules 1000mg Avilable EU
235 Omeprazol Capsule 40mg, 20mg,10 mg Avilable EU
236 Omeprazole powder for soln for inf 40 mg Reference Data EU
237 Ondansetron hcl dehydrate Sol for Inj 8mg/4 ml Reference Data EU
238 Ondansetron hcl dehydrate Sol for Inj 4 mg/2 ml Reference Dta EU
239 Orlistat capsules 120 mg Available EU
240 Ornidazole-Injection 500mg / 100ml Injection   Ethiopia
241 Oxaliplatin Powder for Sol for Inf 5 mg/ml Reference data EU
242 Oxycodone Hcl + Naloxone Hcl Prolonged release Tablet 5/2.5, 10/5, 20/10, 30/15, 40/20 mg Avilable EU
243 Paclitaxel Infusion 30 mg/5 ml; 100 mg/16.7 ml; 150 mg/25 ml; 300 mg/50 ml    
244 Palonosetron Hcl 250 micro soln for inj 250 micro gram Reference data EU
245 Pamidronate disodium 3 mg/ml Reference data EU
246 Pantoprazole gastro-resistant tablets 20 mg 40 mg Tablets Available EU
247 Pantoprazole Powder injection 40mg Reference data EU
248 Paracetamol 500mg tablet 500mg Reference data EU
249 Paracetamol , CPM, phenylephrine & caffine 500/2/25/30   Tajikistan
250 Paracetamol IV Injection 10 mg/ml Reference Data Myanmar
251 Paracetamol Tablet 1000mg Avilable EU
52 Paricalcitol 2 microgram/ml injection 5 microgram/ml, 2 microgram/ml Reference data EU
253 Paroxetine Hcl Extended release Tablet 37.5 mg, 25mg, 12.5g Avilable EU
254 Phloroglucinol 40 mg /4 ml Solution 40mg/4 ml soution for injection Reference Data EU
255 Phloroglucinol 80 mg Orodispersible Tablets 80 mg Orodispersible Tablets Biowaver EU
256 Pioglitazone Hcl USP Tablet 15, 30, 45 mg immediate release oral tablets. Available US
257 Piperacillin + Tazobactam 2G/0.25 g Powder for soln 4g/0.50g, 2g/0.25g Reference data EU
258 Polyvalent Mechanical Bacterial Lysate (PMBL) 50 mg Tablets Reference Data GCC
259 Pramipexole Tablet 0.18, 0.70, 0.35, 0.7, 0.18, 0.088 mg Reference data EU
260 Pramipexole Dihydrochloride Extended-Release Tablets 4.5 , 3.75, 3, 2.25, 1.5, 0.75, 0.375 mg Available EU
261 Pramipexole Prolonged release Tablets 3.15, 2.62, 2.1, 1.57, 1.05, 0.52, 0.26mg Available US
262 Pregabaline hard capsule 300, 225, 200, 150, 100, 75, 50, 25 mg Available EU
263 Purified gamma globulin (IgG) antibodies to Rho (D) antigen. 3 , 6 20 ml Vail Reference Data GCC
264 Quetiapine FCT 300mg, 200mg, 150mg, 100 mg, 25mg Avilable EU
265 Quetiapine Prolonged Release Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg Avilable EU
266 Ramipril Tablets 10mg, 5mg, 2.5mg, 1.25 mg Avilable EU
267 Rasagiline 1 mg tablets 1 mg Avilable EU
268 Rebeprazole delayed release      
269 Remefentanil 1mg/ml powder for inj 5, 2, 1mg/ml for inj Reference data EU
270 Resperidone Tablet      
271 Riluzole 5 mg/ml oral suspension 5 mg/ml oral suspension Available EU
272 Risedronate Sodium Tablets 35 mg Avilable US
273 Risperidone USP Tablet 4, 3, 2, 1, 0.5, 0.25 mg Avilable US
274 Rivaroxaban Tablets 10 mg Available US
275 Rocuronium Solution for Injection 10 mg/ml Reference data EU
276 Ropinirol Hcl Prolonged Release 8mg, 6mg, 4mg,3mg,2mg Tablet Avilable EU
277 Rosuvastatin Calcium Tabelts 40 mg, 20mg, 10mg, 5mg  Avilable US
278 Sevelamer carbonate 800 mg FCT 800 mg FCT Avilable EU
279 SevofluraneCadiasun 100% Inhal vap liq   Reference data EU
280 Sildenafil film-coated tablets 100 mg, 50mg, 25mg Avilable EU
281 Simvastatin FCT      
282 Sitagliptin phosphate Tab 25 50, 100 mg tab Available US
283 Sodium hyaluronate ophthalmic solution 20, 40 mg Eye Drop Refernce Data EU
284 Solifenacin Succinate 5mg 10 mg Tablet   Available US
285 Stopropbarm tabletes 30mg,15 mg Reference data EU
286 Stricil Solution for Injection 50 mg/ml Reference data EU
287 Stritarabine Solution 20 mg/ml Reference data EU
288 Subunit Keyhole limpet Hemocyanin (KLH) 20mg/ml vail Reference EU
289 Tadalafil Tablets   Avilable US
290 Tadalafil Tablets 25 mg, 20mg, 10mg, 5mg Available EU
291 Telmisartan 80mg,40mg, 20mg Avilable EU
292 Telmisartan and Amlodipine Tablets 80/10 mg, 80/5, 40/10, 40/5 mg Available EU
293 Tenofovir Disoproxil FCT 204mg, 163 mg,123mg FCT Available EU
294 Terbinafine Tablet      
295 Thiopental 1000 mg powder for inj 1000 mg for inj, 500mg Reference data EU
296 Tianeptine Sodium film coated Tablet 12.5mg Avilable EU
297 Ticagrelor Tablets 90 mg 90 mg Available US
298 Timolol maleate eye drops 0.50% Eye Drop Reference Data EU
299 Tobramycin 40 mgml 40 mg/ml Reference data EU
300 Tramadol/Paracetamol FCT 37.5mg/325mg Reference data EU
301 Trimetazidine modified release tablets 35mg Avilable EU
302 Ursodeoxycholic acid 250mg. Reference data EU
303 Valsartan 160mg, 80mg, 40 mg Avilable EU
304 Valsartan & Hydrochlorothiazide Tab 320/25, 320/12.5, 160/25, 160/12.5, 80/12.5 mg Avilable US
305 Vancomycin Hard gelatin cap. 250mg, 125 mg Reference data EU
306 Vardenafil Hcl Orally Disintegrated 10 mg Tablet   Available US
307 Vardinafil Hcl orally Disintegrating Tab 10 mg Available US
308 Venlafaxine HCl Extended release cap 225mg,150 mg, 75mg Available EU
309 Venovit capsules hard 180 mg Reference data EU
310 Vinorelbine infusion 10mg/ml Reference data EU
311 Vitamin A palmitate eye ointment Eye Ointment Module 3 EU
312 Vitamin D3 50000IU Reference data  
313 Voriconazole powder sol for infu 200 mg Reference data EU
314 WET-COMOD, eye drops Eye Drop Reference Data EU
315 Xylometazoline hydrochloride nasal spray solution 1 mg nasal spray solution Reference Data EU
316 Zoledronic acid 0.8 mg/ml Reference data EU
317 Zoledronic acid 5 mg/100ml Reference data EU
318 Zolmitriptan Tablets 5 mg, 2.5 mg Available US
319 Zolpidem tartrate 10mg 10 mg Tablet Available EU
320 Zonisamide Tablets 100mg 100 mg Tablet Module 3 EU
  Tacrolimus Capsules 0.5 mg 1mg, 0.5 mg Cap Reference CTD
  Iron Sucrose Injection USP 20mg/ml 20mg/ml Reference CTD
  Ivabradine Tablets 5mg 5 mg tablet Reference CTD
  Pimecrolimus Cream 1% w/w Cream 1% w/w Reference CTD

What is Common Technical Document (CTD) ?

A collection of requirements for a dossier for the registration of medications is known as the Common Technical Document (CTD). The Therapeutic Goods Administration (TGA) approved the CTD in 2004 after the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) formulated it.

The introduction of appropriate review practises in Pharma industry has been made possible by the way CTD has revolutionised the regulatory review processes and led to a standardised electronic submission. For businesses, it has removed the requirement to alter the data before submitting it to the various ICH regulatory bodies.

There are five modules in the CTD. Modules 2, 3, and 4 are meant to be universal for all regions, while Module 1 is region-specific. The CTD became the preferred format for NDAs submitted to the FDA in the United States and the EU in July 2003, and it is now required for new drug applications in Japan and the EU.

What is Dossier?

The information required to support the quality, safety, and effectiveness of a prescription drug is contained in or referred to in a dossier. The supporting data consists of the first dossier, any subsequent dossiers submitted to the TGA that are cited in the application, and any other supporting information submitted after the initial application filing constitute the supporting data.

Frequently Asked Questions

Disclaimer: The information presented in this article is for informational and educational purposes only. While every effort has been made to ensure data accuracy and reliability, readers are advised to independently verify all figures, regulations, and market insights before making any business or investment decisions.
PharmaTradZ Logo

Advertise on PharmaTradZ

Reach verified pharma buyers, suppliers & decision makers worldwide.

Discover Opportunities
PharmaTradZ Logo

Explore Pharma Investment Opportunities

Connect with partners, startups & ventures driving the future of pharma.

Discover Opportunities
PharmaTradZ Logo

Grow Your Pharma Brand

Advertise on the fastest-growing B2B pharma marketplace.

Start Advertising

Subscribe to Our Newsletter

Stay updated on pharma trends and marketplace opportunities.

Please enter the correct answer.
Join WhatsApp Group for Latest Updates
This website uses cookies to ensure you get the best experience. By using our site, you agree to our Privacy Policy.