Product |
Therapeutic category |
US-DMF |
CEP |
E-DMF |
Filed |
Approved |
Ready |
Filed |
Meropenem(Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
Meropenem and Sodium carbonate (Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
Imipenem(Sterile) |
Anti-infective |
P |
|
P |
P |
Cilastatin sodium
(sterile Bulk) |
Anti-infective |
P |
|
P |
P |
Imipenem and Cilastatin sodium for Injection (Sterile Bulk) |
Anti-infective |
P |
|
P |
P |
Alendronate sodium |
Bone resorption Inhibitor |
P |
P |
P |
|
Alfuzosin Hydrochloride |
Benign Prostate Hyperplasia |
P |
P |
|
P |
Amisulpiride |
Anti-Psychotic |
|
|
P |
|
Amlodipine Besylate |
Anti- Hypertensive |
P |
P |
|
P |
Amoxicillin Sodium Sterile |
Beta-Lactam antibiotic |
|
|
|
P |
Amoxicillin Trihydrate |
Anti-Infective |
P |
P |
|
P |
Ampicillin + Sulbactam |
Beta-Lactam antibiotic |
P |
|
P |
|
Ampicillin Sodium Sterile |
Anti-Infective |
P |
P |
|
P |
Ampicillin Trihydrate |
Anti-Infective |
P |
P |
P |
|
Ampicillin Trihydrate Sterile (VMF) |
Anti-Infective |
P |
|
P |
|
Aripiprazole |
Anti- Psychotic |
|
|
Q3-2010 |
|
Atazanavir |
HIV Infections |
|
|
Q4-2010 |
|
Atomoxetine Hydrochloride |
Anti- depressant |
P |
|
P |
|
Atorvastatin |
Lipid lowering agent |
|
|
Q3-2010 |
|
Balsalazide |
Anti Ulcerative |
|
|
Q2-2010 |
|
Benazepril Hydrochloride |
Anti- Hypertensive |
P |
P |
P |
|
Betahistine |
Histamine agonist |
|
|
Q4-2010 |
|
Bisoprolol Fumarate |
Beta Blocker-Anti Hypertensive |
P |
P |
P |
|
Bupropion Hydrochloride |
Anti- depressant |
P |
|
P |
|
Candesartan Cilexetil |
Anti- Hypertensive |
|
|
Q3-2010 |
|
Carvedilol Hcl |
Beta Blocker- Antihypertensive |
P |
P |
|
P |
Cefazolin sodium sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
Cefdinir |
Cephalosporin antibiotic |
P |
|
P |
|
Cefepime for Inj |
Cephalosporin antibiotic |
P |
P |
|
P |
Cefixime Trihydrate |
Anti-Infective |
|
P |
|
P |
Cefotaxime Sodium Sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
Cefoxitin Sodium Sterile |
Cephalosporin antibiotic |
P |
|
|
P |
Cefpodoxime Proxetil |
Cephalosporin antibiotic |
P |
|
|
P |
Cefprozil |
Cephalosporin antibiotic |
P |
|
|
P |
Ceftazidime Pentahydrate Sterile |
Cephalosporin antibiotic |
P |
P |
|
P |
Ceftiofur Hydrochloride |
Anti-bacterial (Veterinary) |
P |
|
|
P |
Ceftiofur Sodium Sterile (VMF) |
Anti-bacterial (Veterinary) |
P |
|
|
P |
Ceftriaxone Sodium Sterile |
Cephalosporin antibiotic |
P |
P |
P |
|
Cefuroxime Axetil |
Cephalosporin antibiotic |
P |
P |
|
P |
Cefuroxime Sodium Sterile |
Cephalosporin antibiotic |
P |
|
|
P |
Celecoxib |
Pain Management |
|
|
Q4-2010 |
|
Cephapirin Benzathine (VMF) |
Anti-Infective (Veterinary) |
P |
|
|
|
Citalopram Hbr |
Anti- depressant |
P |
|
|
P |
Clindamycin Hcl |
Amino gycoside antibiotic |
|
|
Q4-2010 |
|
Clindamycin Palmitate Hcl |
Amino gycoside antibiotic |
P |
|
P |
|
Clopidogrel Bisulfate |
Anti Thrombotic |
P |
|
|
P |
Cloxacillin Sodium |
Beta-Lactam antibiotic |
|
P |
P |
|
Darifenacin Hydrobromide |
Urinary Incontinence |
|
|
Q4-2010 |
|
Dicloxacillin Sodium |
Beta-Lactam antibiotic |
P |
|
|
P |
Domperidone Maleate |
Anti- Emetic |
|
P |
|
P |
Donepezil |
Alzheimer's Disease |
P |
|
|
P |
Doxazosin Mesylate |
BPH treatment |
P |
P |
P |
|
Duloxetine |
Anti-depressant |
P |
|
P |
|
Entacapone |
Parkinson's disease |
|
|
Q4-2010 |
|
Escitalopram oxalate |
Anti-depressant |
P |
|
|
P |
Esomeprazole Magnesium |
Anti- Ulcerant |
|
|
Q3-2010 |
|
Famciclovir |
Dermatological Infections |
P |
|
P |
|
Felodipine |
Anti- Hypertensive |
P |
P |
P |
|
Finasteride |
BPH treatment |
P |
P |
|
|
Florfenicol (VMF) |
Anti-bacterial (Veterinary) |
P |
|
|
P |
Flucloxacillin Sodium |
Beta Lactam antibiotic |
|
P |
P |
|
Flucloxacillin Sodium Sterile |
Beta Lactam antibiotic |
|
P |
P |
|
Fluconazole |
Gynecology |
P |
P |
|
P |
Fluvastatin Sodium |
Lipid lowering agent |
P |
P |
P |
|
Fosinopril Sodium |
Anti- Hypertensive |
P |
|
|
P |
Galantamine |
Alzheimer's Disease |
P |
|
P |
|
Ibandronate |
Bone resorption Inhibitor |
P |
|
P |
|
Irbesartan |
Anti- Hypertensive |
P |
|
|
P |
Lamivudine |
HIV Infections |
P |
|
Q2-2010 |
|
Lamotrigine |
Anti epileptic |
P |
P |
|
P |
Levetiracetam |
Anti epileptic |
P |
|
P |
|
Levofloxacin |
Quinolone antibiotic |
P |
|
P |
|
Losartan Potassium |
Anti- Hypertensive |
P |
|
|
P |
Meloxicam |
COX Inhibitor |
P |
P |
|
P |
Mirtazapine |
Anti-depressant |
P |
P |
|
P |
Modafinil |
CNS stimulant |
|
|
Q4-2010 |
|
Moxifloxacin Hydrochloride |
Quinolone |
|
|
Q2-2010 |
|
Nafcillin Sodium for injection |
Beat Lactam Antibiotic |
P |
|
P |
|
Nateglinide |
Anti-diabetic |
|
|
Q2-2010 |
|
Nevirapine Anhydrous |
HIV Infections |
P |
|
P |
|
Olanzapine |
Anti- Psychotic |
P |
|
P |
|
Omeprazole |
Anti- Ulcerative |
P |
P |
P |
|
Omeprazole Magnesium |
Anti- Ulcerative |
P |
P |
P |
|
Ondansetron Hydrochloride |
Nausea & Vomiting |
P |
P |
|
P |
Oxacillin Sodium (Non-sterile) |
Beta Lactam antibiotic |
P |
P |
P |
|
Oxacillin Sodium sterile |
Beta Lactam antibiotic |
P |
|
P |
|
Pantoprazole sodium sesquihydrate |
Anti-Ulcerant |
P |
P |
|
P |
Paroxetine HCl |
Anti-depressant |
P |
P |
|
P |
Perindopril |
Anti- Hypertensive |
P |
P |
|
P |
Pioglitazone |
Anti-diabetic |
P |
|
P |
|
Pramipexole |
Parkinson's disease |
P |
|
P |
|
Pregabalin |
Anti epileptic |
|
|
Q4-2010 |
|
Quetiapine Fumarate |
Anti epileptic |
P |
|
|
P |
Quinapril Hydrochloride |
Anti- Hypertensive |
P |
|
|
P |
Rabeprazole Sodium |
Anti- Ulcerative |
P |
|
P |
|
Raloxifene |
Bone resorption Inhibitor |
|
|
Q2-2010 |
|
Ramipril |
Anti- Hypertensive |
P |
P |
P |
|
Repaglinide |
Anti-diabetic |
P |
P |
P |
|
Ribavirin |
Hepatitis B infections |
P |
P |
|
P |
Risedronate Sodium |
Bone resorption Inhibitor |
P |
|
|
P |
Risperidone |
Anti- depressant |
P |
P |
|
P |
Rivastigmine Tartrate |
Parkinson's disease |
|
|
Q3-2010 |
|
Rizatriptan Benzoate |
Anti-migraine |
P |
|
P |
|
Rosuvastatin |
Lipid lowering agent |
P |
|
P |
|
Sulbactam Sodium Sterile |
Anti-Infective |
P |
P |
|
P |
Sultamicillin Base |
Anti-Infective |
|
|
P |
|
Sultamycillin Tosylate |
Anti-Infective |
|
P |
P |
|
Sumatriptan Succinate |
Anti-migraine |
P |
P |
|
P |
Tadalafil |
Erectile dysfunction |
|
|
P |
|
Tamsulosin Hydrochloride |
Benign Prostate Hyperplasia |
P |
P |
P |
|
Telmisartan |
Anti- Hypertensive |
|
|
Q4-2010 |
|
Terazosin Hydrochloride |
Benign Prostate Hyperplasia |
P |
P |
P |
|
Terbinafine Hydrochloride |
Dermatological Infections |
P |
P |
|
P |
Tolterodine Tartrate |
Urinary Incontinence |
P |
|
P |
|
Topiramate |
Anti epileptic |
P |
|
|
P |
Torasemide |
Diuretic |
P |
P |
P |
|
Trandolapril |
Anti- Hypertensive |
P |
P |
P |
|
Valacyclovir Hydrochloride |
Dermatological Infections |
P |
|
|
P |
Valganciclovir |
Dermatological Infections |
|
|
Q4-2010 |
|
Valsartan |
Anti- Hypertensive |
P |
|
P |
|
Zaleplon |
Insomnia |
P |
|
P |
|
Zidovudine |
HIV Infections |
P |
P |
|
P |
Ziprasidone |
Anti- Psychotic |
P |
|
P |
|
Zolpidem |
Insomnia |
P |
P |
|
P |
PRODUCTS UNDER DEVELOPMENT |
Armodafinil |
CNS stimulant |
|
|
|
|
Bosentan |
Anti-hypertensive |
|
|
|
|
Cinacalcet Hydrochloride |
Hypercalcemia |
|
|
|
|
Deferasirox |
Iron Chelator |
|
|
|
|
Dutasteride |
BPH treatment |
|
|
|
|
Eletriptan Hydrobromide |
Anti-migraine |
|
|
|
|
Entecavir |
Hepatitis B infections |
|
|
|
|
Esomeprazole sodium |
Anti- Ulcerant |
|
|
|
|
Ezetimibe |
Hyper- Cholesterolemia |
|
|
|
|
Fondaparinux sodium |
Anti Thrombotic |
|
|
|
|
Lacosamide |
Anti-epileptic |
|
|
|
|
Olmesartan |
Hypertension |
|
|
|
|
Omeprazole sodium |
Anti- Ulcerant |
|
|
|
|
Palonosetron Hydrochloride |
Anti-emetic |
|
|
|
|
Paliperidone |
Schizophernia |
|
|
|
|
Ranolazine |
Chronic Angina Pectoris |
|
|
|
|
Sildenafil citrate |
Erectile dysfunction |
|
|
|
|
Sitagliptin Phosphate |
Anti-diabetic |
|
|
|
|
Solifenacin Succinate |
Urinary Incontinence |
|
|
|
|
Varenicline Tartrate |
Aid to smoking cessation |
|
|
|
|
Voriconazole |
Anti-fungal |
|
|
|
|