pharma actd dossierspharma Regulatory documentationpharmaPharma ACTD DossiersdossiersDossiers

Products List Of Ready Dossiers

 




 

Sr. No Product Name Strength Region Format Module BE Study
251 Metoprolol tartrate 100mg 50mg Tablet 100 mg 50mg tablet EU Available
252 Metoprolol tartrate SR 200 mg 200mg SR Tablet EU Available
253 Metoprolol tratarate & Hydrochlorothiazide 100/50 mg, 100/25, 50/25 mg EU Available
254 Metronidazole Gel Ethiopia Reference Data
255 Metronidazole 5 mg/ml Solution for Infusion 5 mg/ml Solution for Infusion EU Module 1 2 3
256 Metronidazole Capsule USP 375 mg US Available
257 Metronidazole Dental Gel 1 Ethiopia Reference Data
258 Metronidazole Tablets USP 500 mg, 250 mg US Available
259 Metronidazole-gel gel EU Ethiopia
260 Mitomycin Solution for Injection 40mg/ml EU Reference Data
261 Mitoxantrone Concentrate Sol for Infu 2 mg/ml EU Reference Data
262 Mitoxantrone hydrochloride Conc Sol inj 2 mg/ml EU Reference Data
263 Modafinil Tablets USP 200mg, 100 mg US Available
264 Montelukast 10 mg tablet US Available
265 Montelukast Sodium Chewable tab 10 mg Tanzania
266 Moxifloxacin FCT 400mg GCC Available
267 Mycophenolic Acid Tablets 360 mg US Available
268 Nebivolol Tablets 20 mg, 10mg, 5mg, 2.5 mg Mayanmar Reference Data
269 Nicorandil Tablet 20mg, 10mg EU Available
270 Nicotin Chewing gum
271 Nisoldipine ER Tablets 34 mg, 25mg, 17.5mg,8.5mg US Available
272 Nitisinone Capsule 2mg, 5mg, 10mg cap US Avilable (M1 M3 M5)
273 Ofloxacin eye drops, solution 3mg/ml EU Reference data
274 Ofloxacin 0.5 ml single dose 0.5 ml EU Reference data
275 Olanzapine Film Coated Tablet 10 mg, 5mg EU Available
276 Olmesartan & Hydrochlorothiazide Tablets 40/25 mg, 40/12.5, 20/25, 20/12.5 mg US Available
277 Olmesartan Medoxomil Tablets 40 mg, 20mg, 10mg EU Available
278 Olopatadine Ophthalmic solution USP 0.1 % ‘0.1 % US Reference data
279 Omega-3-Acid Ethyl Esters 90 Momaja 1000mg Soft Gel Capsules 1000mg EU Available
280 Omeprazol Capsule 40mg, 20mg,10 mg EU Available
281 Omeprazole powder for soln for i 40mg EU Reference data
282 Ondansetron hcl dehydrate Sol for Inj 8mg/4 ml EU Reference data
283 Ondansetron hcl dehydrate Sol for Inj 4 mg/2 ml EU Reference data
284 Orlistat capsules 120mg EU Available
285 Ornidazole-Injection 500mg / 100ml Injection Ethiopia
286 Oxaliplatin Powder for Sol for Inf 5 mg/ml EU Reference Data
287 Oxycodone Hcl + Naloxone Hcl Prolonged release Tablet 5/2.5, 10/5, 20/10, 30/15, 40/20 mg EU Available
288 Paclitaxel Infusion 30 mg/5 ml; 100 mg/16.7 ml; 150 mg/25 ml; 300 mg/50 ml
289 Palonosetron Hcl 250 micro soln for inj 250 micro gram EU Reference Data
290 Pamidronate disodium 3 mg/ml EU Reference Data
291 Pantoprazole gastro-resistant tablets 20 mg 40 mg Tablets EU Available
292 Pantoprazole Powder injection 40mg EU Reference Data
293 Paracetamol 500mg tablet 500mg EU Reference Data
294 Paracetamol , CPM, phenylephrine & caffine 500/2/25/30 Tajikistan
295 Paracetamol IV Injection 10 mg/ml Myanmar Reference Data
296 Paracetamol Tablet 1000mg EU Available
297 Paricalcitol 2 microgram/ml injection 5 microgram/ml, 2 microgram/ml EU Reference Data
298 Paroxetine Hcl Extended release Tablet 37.5 mg, 25mg, 12.5g EU Available
299 Phloroglucinol 40 mg /4 ml Solution 40mg/4 ml soution for injection EU Reference Data
300 Phloroglucinol 80 mg Orodispersible 80 mg Orodispersible Tablets EU Biowaver
301 Pioglitazone Hcl USP Tablet 15, 30, 45 mg immediate release oral tablets. US Available
302 Piperacillin + Tazobactam 2G/0.25 g Powder for soln 4g/0.50g, 2g/0.25g EU Reference Data
303 Polyvalent Mechanical Bacterial Lysate (PMBL) 50 mg Tablets GCC Reference Data
304 Pramipexole Tablet 0.18, 0.70, 0.35, 0.7, 0.18, 0.088 mg EU Reference Data
305 Pramipexole Dihydrochloride Extended-Release Tablets 4.5 , 3.75, 3, 2.25, 1.5, 0.75, 0.375 mg EU Available
306 Pramipexole Prolonged release Tablets 3.15, 2.62, 2.1, 1.57, 1.05, 0.52, 0.26mg US Available
307 Pregabaline hard capsule 300, 225, 200, 150, 100, 75, 50, 25 mg EU Available
308 Purified gamma globulin (IgG) antibodies to Rho (D) antigen. 3 , 6 20 ml Vail GCC Reference data
309 Quetiapine FCT 300mg, 200mg, 150mg, 100 mg, 25mg/td> EU Available
310 Quetiapine Prolonged Release Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg EU Available
311 Ramipril Tablets 10mg, 5mg, 2.5mg, 1.25 mg EU Available
312 Rasagiline 1 mg tablets 1mg EU Available
313 Rebeprazole delayed release
314 Remefentanil 1mg/ml powder for inj 5, 2, 1mg/ml for inj EU Reference data
315 Resperidone Tablet
316 Riluzole 5 mg/ml oral suspension 5 mg/ml oral suspension EU Available
317 Risedronate Sodium Tablets 35 mg US Available
318 Risperidone USP Tablet 4, 3, 2, 1, 0.5, 0.25 mg US Available
319 Rivaroxaban Tablets 10mg US Available
320 Rocuronium Solution for Injection 10 mg/ml EU Reference data
321 Ropinirol Hcl Prolonged Release 8mg, 6mg, 4mg,3mg,2mg Tablet EU Available
322 Rosuvastatin Calcium Tabelts 40 mg, 20mg, 10mg, 5 US Available
323 Sevelamer carbonate 800 mg FCT 800 mg FCT EU Available
324 SevofluraneCadiasun 100% Inhal vap liq EU Reference data
325 Sildenafil film-coated tablets 100 mg, 50mg, 25mg EU Available
326 Simvastatin FCT
327 Sitagliptin phosphate Tab 25 50, 100 mg tab US Available
328 Solifenacin Succinate 5mg 10 mg Tablet US Available
329 Solifenacin Succinate 5mg 10 mg Tablet US Available
330 Stopropbarm tabletes 30mg,15 mg EU Reference Data
331 Stricil Solution for Injection 50 mg/ml EU Reference Data
332 Stritarabine Solution 20 mg/ml EU Reference Data
333 Subunit Keyhole limpet Hemocyanin (KLH) 20mg/ml vail EU Reference Data
334 Tadalafil Tablets 1 US Available
335 Tadalafil Tablets 25 mg, 20mg, 10mg, 5mg EU Available
336 Telmisartan 80mg,40mg, 20mg EU Available
337 Telmisartan and Amlodipine Tablets 80/10 mg, 80/5, 40/10, 40/5 mg EU Available
338 Tenofovir Disoproxil FCT 204mg, 163 mg,123mg FCT EU Available
339 Terbinafine Tablet
340 Thiopental 1000 mg powder for in 1000 mg for inj, 500mg EU Reference Data
341 Tianeptine Sodium film coated Tablet 12.5mg EU Available
342 Ticagrelor Tablets 90 mg 90 mg/td> US Available
343 Timolol maleate eye drops 0.50% Eye Drop EU Reference Data
344 Tobramycin 40 mgml 40 mg/ml EU Reference Data
345 Tramadol/Paracetamol FCT 37.5mg/325mg EU Reference Data
346 Trimetazidine modified release tablets 35mg EU Available
347 Ursodeoxycholic acid 25MG eu Reference Data
348 Valsartan 160mg, 80mg, 40 mg EU Available
349 Valsartan & Hydrochlorothiazide Tab 320/25, 320/12.5, 160/25, 160/12.5, 80/12.5 mg US Available
350 Vancomycin Hard gelatin cap. 250mg, 125 mg EU Reference data
351 Vardenafil Hcl Orally Disintegrated 10 mg Tablet US Available
352 Vardinafil Hcl orally Disintegrating Tab 10 mg US Available
353 Venlafaxine HCl Extended release cap 225mg,150 mg, 75mg EU Available
354 Venovit capsules hard 180 mg EU Reference data
355 Vinorelbine infusion 10mg/ml EU Reference data
356 Vitamin A palmitate eye ointment Eye Ointment EU Module 3
357 Vitamin D3 50000IU Reference data
358 Voriconazole powder sol for infu 200 mg EU Reference data
359 WET-COMOD, eye drops Eye drop EU Reference data
360 Xylometazoline hydrochloride nasal spray solution 1 mg nasal spray solution EU Reference data
361 Zoledronic acid 0.8 mg/ml EU Reference data
362 Zoledronic acid 5 mg/100ml EU Reference data
363 Zolmitriptan Tablets 5 mg, 2.5 mg US Available
364 Zolpidem tartrate 10mg 10 mg Tablet EU Available
365 Zonisamide Tablets 100mg 100 mg Tablet EU Module 3
366 Tacrolimus Capsules 0.5 mg 1mg, 0.5 mg Cap CTD Reference Data
367 Iron Sucrose Injection USP 20mg/ml 3 mg/ml CTD Reference Data
368 Ivabradine Tablets 5mg 5 mg tablet CTD Reference Data
369 Pimecrolimus Cream 1% w/w Cream 1% w/w CTD Reference Data
370 Abacavir Sulfate and Lamivudine Tablets Tablets, 60 mg/30 mg EU Reference Data
371 Abacavir sulfate Tablets Tablets 60 mg EU Reference Data
372 Abacavir sulfate Tablets Tablets 300 mg EU Reference Data
373 AcamprosateCalcium delayed release tablets Tablets 333 mg EU Reference Data
374 Alprazolam Tablets Tablets 0.5 mg EU Reference Data
375 Alprazolam Tablets Tablets 1 mg CTD Reference Data
376 Alprazolam Tablets Tablets 2mg CTD Reference Data
377 Abacavir Sulfate,Lamivudine and Zidovudine Tablets Tablets 300,150,300 mg CTD Reference Data
378 Amlodipine Besylate and Atorvastatin Tablets Tablets 2.5/10,2.5/20,2.5/40,5/10,5/20,5/40,5/80,10/10,10/20,10/40 and 10/80 mg CTD Reference Data
379 Amlodipine Besylate and Olmesartan medoxomil Tablets Tablets 5/20 and 10/40 mg CTD Reference Data
380 Amlodipine Besylate and Valsartan Tablets Tablets 10/320 mg,5/160,5/320 and 10/160 mg EU Reference Data
381 Armodafinil Tablets Tablets 50/150/250 mg EU Reference Data
382 Atazanavir Sulfate Capsules Capsules 150 mg and 300 mg EU Reference Data
383 Atovaquone and Proguanil HCl Tablets Tablets 62.5/25 mg and 250/100 mg EU Reference Data
384 Atorvastatin Tablets Tablets 10,20,40,80 mg EU Reference Data
385 Baclofen Tablets Tablets USP 10 mg and 20 mg CTD Reference Data
386 Candesartan Cilexetil/HCTZ Tablets Tablets 16/12.5, 32/12.5 CTD Reference Data
387 Candesartan Cilexetil Tablets Tablets 4,8,16 and 32 mg CTD Reference Data
388 Carvedilol Tablets Tablets USP 3.125 , 6.25 , 12.5 , 25 CTD Reference Data
389 Clindamycin HCl Capsules Capsules USP75/150/300 mg CTD Reference Data
390 Darunavir Tablets 75/150/300/400/600 mg Tablets 75/150/300/400/600 mg EU Reference Data
391 Desmopressin Acetate Tablets Tablets 0.1/0.2 mg EU Reference Data
392 Didanosine delayed release capsule capsule 125 mg,200 mg,250 mg & 400 mg EU Reference Data
393 Donepezil HCl Tablets Tablets 5/10 mg EU Reference Data
394 Donepezil Hydrochloride Tablets Tablets 23 mg CTD Reference Data
395 Efavirenz Tablets Tablets 50/100/200 mg CTD Reference Data
396 Efavirenz Tablets Tablets 600 mg CTD Reference Data
397 Entacapone Tablets Tablets 200 mg CTD Reference Data
398 Entecavir Tablets Tablets 0.5 mg and 1 mg CTD Reference Data
399 Esomeprazole Capsule Capsule 20/40 mg EU Reference Data
400 Ezetimibe and Simvastatin Tablets Tablets 10/10,20,40,80 mg EU Reference Data
401 Ezetimibe Tablets Tablets 10 mg EU Reference Data
402 Famciclovir tablets Tablets 125/250/500 mg EU Reference Data
403 Fenofibrate Capsule Capsule 100 /300 mg EU Reference Data
404 Fenofibrate Tablets Tablets 40/120 mg EU Reference Data
405 Fosamprenavir Calcium Tablets Tablets 700 mg CTD Reference Data
406 Frovatriptan Succinate Tablets Tablets 2.5 mg CTD Reference Data
407 Gabapentin Tablets Tablets 300/600mg CTD Reference Data
408 Itraconazole capsules Tablets 100 mg CTD Reference Data
409 Lamivudine Tablets Tablets 100 mg CTD Reference Data
410 Minocycline HCl ER Tablets Tablets 65/115 mg EU Reference Data
411 Metoprolol Succinate ER tablets Tablets USP 25/50/100/200 mg EU Reference Data
412 Naratriptan Tablets Tablets 1/2.5 mg EU Reference Data
413 Olanzapine ODT Tablets Tablets 5/10/15/20 mg EU Reference Data
414 Pioglitazone HCl & Metformin HCl ER Tablets Tablets 15/1000 ,30/1000 EU Reference Data
415 Riluzole tablets Tablets USP 50mg CTD Reference Data
416 Voriconazole tablets Tablets 50/200 mg CTD Reference Data
417 Levitiracetam Tablets Tablets 250 mg CTD Reference Data
418 Lithium Carbonate Extended Release Tablets Tablets USP, 300 mg CTD Reference Data
419 Losartan Potassium Tablets Tablets 25/50/100 mg CTD Reference Data
420 Nauserin Injection Injection CTD Reference Data
421 METFORMIN HCI 500MG/5 ML ORAL SOLUTION, 1000 mg Film Tablet EU Available
422 ACARBOSE 50, 100 MG TABLET US Available
423 MEMANTINE HCI 10 MG, 20 MG FILM TABLET, 10 MG/GR ORAL DROP EU Available
424 IMIPENEM+CILASTATIN 500 MG/500 MG IV VIAL(FLACON) GCC Reference data
425 MOMETASONE FUROATE 50 MCG/PÜSKÜRTME, % 0.05 NASAL SPREY EU Available
426 LEVETIRACETAM 250 MG, 500 MG, 750 MG, 1000 MG FILM TABLET EU Available
427 LEVETIRACETAM 500 MG, 750MG XR TABLET EU Available
428 VALSARTAN+HCTZ 80/12.5 MG, 160/12.5 MG, 320/12.5 MG, 160/25 MG, 320/25 MG FILM TABLET EU Available
429 CALCIUM DOBESILAT 500 MG CAPSULE
430 CEFPODOXIME PROXETIL 50 MG/ 5 ML, 100 MG/ 5 ML SÜSPANSİYON,200 MG, 100 MG FILM TABLET, EU Reference data
431 DEKSKETOPROFEN TROMETAMOL 25 MG FILM TABLET, 50 MG / 2 ML AMPOULE
432 CEFDINIR 125 MG/5 ML, 250 MG/5 ML DRY POWDER FOR SUSPANSION, 300 MG CAPSULE EU Available
433 CALCIUMCARBONAT+D3VITAMIN 1000 MG + 880IU EFERVECENT TABLET US Available
434 TERBINAFIN 1 % ONCE CUTANEUS SOLUTION US Available
435 FENOFIBRATE 250 MG SR PELLET CAPSULE US Available
436 FE+3 SUCROSE 100 MG/5 ML IV AMPULE EU Reference data
437 TERBNAFIN+DIFLUROCORTOLNE Available
438 ALENDRONATE SODIUM+D3 70 MG/5600 IU, 70 MG/2800 IU TABLET US Available
439 ENTECAVIR 1 MG, 0.5 MG TABLET, 0.05 MG/ML ORAL SOLUTION EU Available
440 ESOMEPRAZOLE HEMIMAGNSIUM 20 MG, 40 MG ENTERIC COATED PELLET CAPSULE, 10 MG SACHET EU Reference data
441 VENLAFAXIN HCI 37.5 MG, 75 MG, 150 MG XR DELAYED RELEASE CAPSULE EU Available
442 PIOGLITASONE HCI 15 MG, 30 MG, 45 MG TABLET
443 SALMON KALSITONIN 200 IU/2ML/14 DOSE NASAL SPREY US Available
444 GLICLAZIDE 30 MG, 60 MG MR TABLET US Available
445 ADEFOVIR DIPIVOKSIL 10 MG TABLET US Available
446 AMLODIPIN+VALSARTAN-AR-25 5 + 160 MG, 10 + 320 MG FILM TABLET EU Reference Data
447 MOXIFLOXACIN HCI-AR-26 400MG/250ML IV INFUSION SOLUTION, 400 MG FILM TABLET EU Reference Data
448 MEROPENEM TRIHYDRATE-AR-27 500 MG IV, 1000 MG IV DRY POWDER VIAL (FLACON) EU Reference Data
449 STRONTIUM RANELATE-AR-28 2 GR DRY GRANULE SAŞE EU Reference Data
450 SALBUTMOL+ITRAROPIUMBRMÜR-AR-29 100 mcg/20 mcg 200 DOSE AEROSOL INHALER US Available
451 BUDESNID+FORMETROLFUMRATE-AR-30 400mcg + 12 mcg, 400mcg + 12 mcg DRY POWDER INHALER EU Available
452 BUDESNID+FORMETROLFUMRATE-AR-30 80 mcg/4.5 mcg, 120 DOSE PEDIATRIC DRY POWDER(deva:100mcg/6mcg),160 mcg/4.5 mcg, 120 DOSE DRY POWER(deva:200mcg/6mcg) EU Available
453 SLMTROLXINAFOATFLUTCSNPRO-AR-31 25 mcg/50 mcg, 25 mcg/125 mcg, 25 mcg/250 mcg DOSE AEROSOL INHALER EU Available
454 SLMTROLXINAFOATFLUTCSNPRO-AR-31 50mcg / 100mcg 50mcg / 250mcg, 50mcg / 500mcg DRY POWDER INHALER EU Available
455 BECLOMETHASONE 50 mcg/DOSE AUTOHALER AEROSOL INHALER
456 ITRAPROPIUM BROMIDE-AR 20 mcg/ DOSE 200 DOSE INHALER AEROSOL EU Reference Data
457 SALBUTAMOL SÜLFAT-AR 100 mcg/doz, 200 DOZ INHALER AEROSOL EU Available
458 INHALER-AEROSOL GENEL US Available
459 CICLESONIDE 80 mcg, 160 mcg INHALATION SOLUTION, 60 dose EU Reference Data
460 CALCITRIOL 1 mcg / ML AMPULE, 2 mcg / ML AMPULE EU Reference Data
461 ITRACONAZOLE 10 MG/ML AMPOULE EU Reference Data
462 FLUCONAZOLE 2 MG/ ML IV INFUSION (FLACON) EU Available
463 TEICOPLANIN 200MG, 400 mg IM/ IV VIAL (FLACON) eu Reference Data
464 PANTOPRAZOL NA 40 MG IV LIOPHILIZED FLACON EU Available
465 ESOMEPRAZOLE-AR 40 MG IV INFUSION /INJ DRY POWDER VIAL (FLACON) US Available
466 ENOXAPARIN NA-AR 40 MG, 60 MG, 80 MG, 120 MG READY TO USE INJECTOR EU Reference data
467 LEVO-CARNITIN 1 GR/ 5 ML AMPOULE US Available
468 PARİ-KALSİTOL 5 mcg / ML- 1 ML, 5 mcg / ML- 2 ML, 2 mcg / ML- 1 ML AMPOULE US Available
469 ROCURONIUM BROMIDE 50 MG/5 ML IV FLACON EU Available
470 IDARUBICIN 20 MG LYOPHILISED VIAL (FLACON) EU Reference data
471 PIPERACILLIN +TAZOBACTAM 2.25 MG, 4.5 MG LIOPHILIZED FLACON EU Reference data
472 SULBCTAM NA+CEFAPERAZON 1G/ 1G IM/IV, 500 MG/ 500 MG IM/IV POWDER FOR INJECTION VIAL (FLACON) EU Module 3
473 FLURBIPROFEN 200 MG SR CAPSULE Reference data
474 CEFIXIME 400 MG ODT EU Reference data
475 CEFIXIME 400 MG ODT EU Reference data
476 PARACETAMOL 1000 MG/100 ML INFUSION (FLACON) EU Reference data
477 SODYUM VALPROAT 400 MG IV LYOFLYIZED POWDER EU Reference data
478 KETOPROFEN 1 MG/ML SYRUP EU Reference data
479 CHLORHEXIDIN+BENZIDAMIN % 2 (% 0.15 + % 0.12) ORAL SPRAY, % 2 (% 0.15 + % 0.12) GARGLE US Available
480 TERBUTALIN+GUAYIFENESIN 1.5 MG +66.5 MG /5 ML SYRUP EU Available
481 ASPARTAM 18 MG TABLET EU Module 3
482 HAMEMELIS % 0.75 OINMENT, % 0.64 CREAM CTD Reference Data
483 DKSTRMTRFN+PSÖD+KLRFNIRMN 10 MG + 20 MG + 2 MG/5 ML SYRUP CTD Reference Data
484 IBANDRONİK ASİT 6MG/6ML IV INFUSION CTD Reference Data
485 METOPROLOL 5 MG/5ML IV AMPOULE CTD Reference Data
486 FENİTOİN 250 MG/5 ML AMPOULE EU Reference Data
487 PALENOSETRON 250 MCG/5ML IV INJECTABLE FLACON EU Reference Data
488 CIPROFLOXACIN %0.3 OPHTALMIC DROP EU Reference Data
489 DIMENHYDRATE 50MG/ML AMPOULE EU Reference Data
490 TIMOLOL-DERZOLOMIDE 5MG + 20MG/5 ML STERILE OPHTALMIC SOLUTION EU Reference Data
492 BETHAMETHASONE 3 MG / ML AMPOULE CTD Reference Data
493 MULTIVITAMİN PRONATAL FILM TABLET CTD Reference Data
494 PREGABALIN 25 MG, 50 MG, 75 MG, 100 MG, 150 MG, 200 MG, 225 MG, 300 MG CAPSULE CTD Reference Data
495 CEFPROZIL 500 MG TABLET, 250 MG/5ML DRY POWDER FOR SUSPENSION CTD Reference Data
496 ESCITALOPRAM OXALAT 5MG, 10MG, 20MG FILM TABLET CTD Reference Data
497 PEG-FILGRASTIM PEG-FILGRASTIM (6 MG / 0,6 ML) EU Reference Data
498 INTERFRON ALFA2A 3 MIU/ 0,5 ML, 4,5 MIU/ 0,5 ML, 6 MIU/ 0,5 ML, 9 MIU/ 0,5 ML, 8 MIU/ 0,5 ML EU Reference Data
499 PEG-INTERFERON ALFA2A 135 mcg, 180 mcg / 0,5 ML EU Reference Data
500 DICLOFENAC 50 MG/ML, 75 MG MR PELLET CAPSULE (25 enteric+50 sr pellet) EU Reference Data

Products List

Translate »
Pharma