FINISHED DOSAGE FORMS | ||||
| Sl. No. | Product Name | Strengths | Reference Product, Source | Dossier Status |
|---|---|---|---|---|
| Anti - Ulcerative (PPI) | ||||
| 1 | Esomeprazole GR Tablets | 20 & 40 mg | Nexium Tablets (AstraZenica, Netherlands) | EU CTD Available Registered in UK-MHRA |
| 2 | Esomeprazole Capsules | 20 & 40 mg | Nexium Capsules (AstraZenica, USA) | Mar-24 |
| 3 | Dexlansoprazole DDR Capsules | 30 mg and 60 mg | Dexilant (Takeda) | Feb-24 |
| Anti - Bacterial | ||||
| 4 | Linezolid Tablets | 600 mg | Zyvoxid Tablets (Pfizer, Latvia, EU) | Available |
| 5 | Moxifloxacin Tablets | 400 mg | Avalox Tablets (Bayer, Germany) | Available |
| Anti - Diabetic | ||||
| 6 | Vildagliptin Tablets | 50 mg | Galvus Tablets (Novartis, Spain) | EU CTD Available Under registration in UK-MHRA |
| 7 | Vildagliptin and Metformin Tablets | 50/500 mg, 50/850 mg, 50/1000 mg | Eucreas Tablets (Novartis, Italy) | EU CTD Available Under registration in UK-MHRA |
| 8 | Sitagliptin Phosphate Monohydrate Tablets | 25 mg, 50 mg, 100 mg | Januvia Tablets (MSD, Netherlands) | Available |
| 9 | Sitagliptin Phosphate Monohydrate & Metformin HCl (IR) Tablets | 50/500 mg, 50/850 mg & 50/1000 mg | JanuMet Tablets (MSD), Spain | Under compilation |
| 10 | Sitagliptin Phosphate Monohydrate & Metformin HCl (ER) Tablets | 50/500, 50/1000 & 100/1000 mg | JanuMet XR (MSD) | Jun-24 |
| 11 | Linagliptin Tablets | 2.5 mg & 5 mg | Trajenta (Boehringer Ingelheim) | Jul-24 |
| 12 | Linagliptin & Metformin HCl ER Tablets | 2.5/1000 mg, 2.5/850mg & 2.5/500 mg, | Jentadueto XR (Boehringer Ingelheim) | Sep-24 |
| 13 | Empagliflozin Tablets | 10 & 25 mg | Jardiance (Boehringer Ingelheim) | Feb-24 |
| 14 | Empagliflozin and Metformin Tablets | 5 /1000 mg, 12.5/1000 mg, 5 /850 mg, 12.5 /850 mg" |
Synjardy (Boehringer Ingelheim) | Mar-24 |
| 15 | Empagliflozin and Linagliptin Tablets | 10/5 mg, 5/5 mg | Glyxambi (Boehringer Ingelheim) | Apr-24 |
| Smoking Cessation | ||||
| 16 | Varenicline Tablets | 0.5 & 1.0 mg | Champix Tablets (Pfizer, Germany) | Jan-24 |
| Anti - Coagulant | ||||
| 17 | Dabigatran Etexilate Mesylate Capsules | 75, 110 & 150 mg | Pradaxa (Boehringer Ingelheim, Germany) | Available |
| 18 | Apixaban Tablets | 2.5 mg and 5 mg | Eliquis Tablets ( Mfg BMS, Italy) | Oct-23 |
| 19 | Rivaroxaban Tablets | 2.5 mg, 10 mg, 15 mg and 20 mg | Xarelto Tablets (Janssen) | Mar-24 |
| Anti - Fungal | ||||
| 20 | Itraconazole Capsules | 50 mg | Sporanox(Janseen-Cilag NV, Belgium) | Mar-24 |
| Hypercholesterolemia | ||||
| 21 | Bempedoic Acid Tablets | 180 mg | Nexletol (Escerion) | Dec-24 |
| Anti - Convulsant | ||||
| 22 | Brivaracetam Tablets | 10 mg, 25 mg, 50 mg,75 mg and 100 mg | Briviact (UCB) | Dec-24 |
| 23 | Lacosamide Tablets | 50, 100, 150 & 200 mg | Vimpat (UCB) | Jul-24 |
| Anti - Platelet | ||||
| 24 | Ticagrelor Tablets | 60 mg and 90 mg | Brilinta (Astrazeneca) | Mar-24 |
| Attention-deficit hyperactivity disorder (ADHD) | ||||
| 25 | Viloxazine Hydrochloride SR capsules | 100 mg, 150 mg and 200 mg | Qelbree, EU | May-24 |
| Angiotensin Receptor Neprilsrin Inhibitor (ARNI) | ||||
| 26 | Sacubitril, Valsartan Tablets/Capsules | 24 mg/26 mg, 49 mg/51mg,97 mg/103 mg | Entresto, tablets, Germany, EU | Dec-24 |