Finished Dosage Forms
Our organisation helps to prepare / submit and custom clearance of DOSSIER and final order dispatch.
A dossier is a comprehensive collection of documents submitted to regulatory authorities for the approval of pharmaceutical products in any country. It includes detailed information on the product's composition, manufacturing process, quality control measures, clinical trial data, and safety and efficacy profiles. Dossier compliance ensures that the product meets the stringent regulatory requirements of the target market, facilitating its registration and commercialization.
For example, when registering a new drug in the European Union, a pharmaceutical company must compile a Common Technical Document (CTD) dossier. This dossier is divided into five modules: Administrative and Prescribing Information, Overview and Summaries, Quality, Non-Clinical Study Reports, and Clinical Study Reports. Each module must adhere to specific guidelines to ensure the product's safety, efficacy, and quality standards are met before it can be approved for market entry.
Aceclofenac + Paracetamol Tablet | Aceclofenac Tablets | Amlodipine Tablet |
Amlodipine + Benazepril Capsule | Apixaban Tablet | Apremilast Tablet |
Aripiprazole Tablet | Aspirin + Dipyridamol ER Capsule | Atomoxetine Capsule |
Atorvastatin Tablet | Azithromycin Tablets | Azithromycin Tablets |
Bupropion SR Tablet | Canagliflozin + Metformin Tablet | Canagliflozin Tablet |
Candesartan + HCTZ Tablet | Candesartan Tablet | Carbidopa + Levodopa SR Tablet |
Carbidopa + Levodopa + Entacapone Tablet | Cefepime for Injection | Ceftazidime for Injection |
Ceftriaxone + Sulbactam for Injection | Ceftriaxone + Tazobactam for Injection | Ceftriaxone sodium for Injection |
Celecoxib Capsule | Cevimeline Capsule | Chlorthalidone Tablet |
Cholchicine Tablet | Cholestyramine Sachet | Choline Fenofibrate Capsule |
Cinacalcet Tablet | Clopidogrel + Aspirin Tablet | Clopidogrel Tablet |
Colesevelam Tablet | Cyclobenzaprine ER Capsule | Dabigatran Capsule |
Dapaglaflozin Tablet | Darifenacin ER Tablet | Desvenlafaxine ER Tablet |
Dimethylfumarate Capsule | Dolutegravir Tablet | Donepezil Tablet |
Doxycycline Capsules | Duloxetine ER Capsule | Edoxaban TosilateTablet |
Empaglifozin Tablet | Entacapone Tablet | Erectile Dysfunction |
Escitalopram Oral Solution | Escitalopram Tablet | Esomeprazole Capsule |
Eszopiclone Tablet | Ezetimibe Tablet | Famciclovir Tablet |
Febuxostat Tablet | Fenofibrate Tablet | Hydralazine Tablet |
Ibandronate Tablet | Ibuprofen + Famotidine Tablet | Irbesartan + HCTZ Tablet |
Irbesartan Tablet | Lacosamide tablets | Lamivudine + Abacavir + Dolutagravir Tablet |
Lamivudine +Tenofovir DF + Dolutegravir Tablet | Lansoprazole Capsules | Lansoprazole OD Tablet |
Levocetirizine Tablet | Levofloxacin Oral Solution | Levofloxacin Tablet |
Levofloxacin Tablets | Levothyroxine Tablet | Linagliptin + Empagliflozin Tablet |
Linagliptin Tablet | Linezolid Tablet | Liothyronine Tablet |
Losartan + HCTZ Tablet | Losartan Tablet | Lurasidone Tablet |
Memantine ER + Donepezil Capsule | Memantine ER Capsule | Memantine Oral Solution |
Memantine Tablet | Meropenem for Injection | Metaxalone Tablet |
Metformin Tablet | Methimazole Tablet | Metoprolol ER Tablet |
Milnacipran Tablet | Montelukast + Levocetirizine HCl Tablet | Montelukast Chewable Tablet |
Montelukast Granules | Montelukast Tablet | Montelukast + Levocetirizine Tablet |
Moxifloxacin Tablet | Nebivolol Tablet | Niacin ER Tablet |
Nitrofurantoin Capsule | Nitrofurantoin Suspension | Olanzapine OD Tablet |
Olanzapine Tablet | Olmesartan + Amlodipine + HCTZ Tablet | Olmesartan + Amlodipine Tablet |
Olmesartan + HCTZ Tablet | Olmesartan Tablet | Ondansetron HCl Disintegrating Tablet |
Oseltamivir Capsule | Oxcarbazepine Suspension | Pantoprazole Sodium DR Tablet |
Perphenazine Tablet | Phenytoin SR Capsule | Pindolol Tablet |
Pioglitazone Tablet | Piperacillin + Tazobactam for Injection | Potassium Chloride ER Tablet |
Pramipexole ER Tablet | Pramipexole IR Tablet | Prasugrel Tablet |
Pregabalin Capsule | Pregabalin SR Tablet | Propylthiouracil Tablet |
Quetiapine Tablet | Rabeprazole Tablets | Raloxifene Tablet |
Rasagiline Tablet | Repaglinide Tablet | Risedronate Tablet |
Rivaroxaban Tablet | Rivastigmine Capsule | Rizatriptan OD Tablet |
Rizatriptan Tablet | Rosuvastatin Tablet | Sevelamer Carbonate Suspension |
Sevelamer Carbonate Tablet | Sildenafil Citrate Tablet | Silodosin IR Capsule |
Sitagliptin + Metformin Tablet | Sitagliptin Tablet | Sofosbuvir + Velpatasvir Tablet |
Sofosbuvir Tablet | Solifenacin Tablet | Tadalafil Tablet |
Tamsulosin Capsule | Telmisartan + HCTZ Tablet | Telmisartan Tablet |
Thiocolchicoside + Aceclofenac Tablet | Ticagrelor Tablet | Tolterodine ER Capsule |
Tolterodine IR Tablet | Tramadol + Acetaminophen Tablet | Tramadol ER Tablet |
Tramadol Tablet | Tranexamic acid + Mefenamic acid Tablets | Tranexamic acid Injection |
Tranexamic acid Tablets | Triamterine + HCTZ Tablet | Trospium Tablet |
Valsartan + Amlodipine + HCTZ Tablet | Valsartan + Amlodipine Tablet | Valsartan + HCTZ Tablet |
Valsartan Tablet | Vardenafil IR Tablet | Vardenafil ODT Tablet |
Venlafaxine ER Capsule | Vildagliptin + Metformin Tablet | Warfarin Tablet |
Ziprasidone Capsule | Zolmitriptan Film Coated Tablet | Zolmitriptan OD Tablet |