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Office Address

SDS BUSINESS HUB Corporate Business Park, 508, Vihav Trade Center, Near Waves Club, Bhayali Canal Ring Road, Bhayali, Vadodara. Gujarat, India. 390012.

Phone Number

+91 7600661605

Email Address

care@sdsbusinesshub.com

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