Active Pharmaceutical Ingredients
To help patients get access to affordable and innovative medicines, Mankind focuses on creating high and quality Active Pharmaceutical Ingredients. Drawing on its expertise and capabilities in innovative research and development, Mankind manufactures NCEs, Generic APIs, advanced Organic Intermediates, Agro-chemicals for domestic, semi-regulated and regulated markets.
Commercial Products
Sr. No. | Category | Product | Pharmacopoeia | Therapeutic Class | USDMF | CEP | EDMF | DMF - ROW |
---|---|---|---|---|---|---|---|---|
1 | Commercial | Atorvastatin Calcium | IP/USP/EP | Antilipemic Agent | Filed - 034844 | Filed (Q1 2022) | - | Available |
2 | Commercial | Baclofen | USP/EP | Muscle relaxant | Filed - 037011 | To be Filed | - | Available |
3 | Commercial | Brivaracetam | IH/IP | Anticonvulsants | - | - | - | Available |
4 | Commercial | Clomipramine HCl | USP/EP | Antidepressant | Filed - 034935 | Approved | Available | Available |
5 | Commercial | Clozapine | USP/EP | Neuroleptic agent | Filed - 037540 | - | - | Available |
6 | Commercial | Cilnidipine | IH | Antihypertensive | - | - | - | Available |
7 | Commercial | Dydrogesterone | USP/EP/IP | Menstrual Disorders & Infertility | To be Filed | To be Filed | - | Under Compilation |
8 | Commercial | Etoricoxib | IH/IP | Antiarthritis | - | - | Available | Available |
9 | Commercial | Haloperidol Base | USP/EP | Antipsychotic | Filed - 034190 | Approved | Available | Available |
10 | Commercial | Haloperidol Decanoate | USP/EP | Antipsychotic | Filed - 034353 | Approved | Available | Available |
11 | Commercial | Lasmiditan Hemisuccinate | IH | Acute Migraine | - | - | - | Available |
12 | Commercial | Lifitegrast | IH | Dry Eyes Syndrome | - | - | - | Available |
13 | Commercial | Luliconazole | IH | Antifungal | - | - | - | Available |
14 | Commercial | Nitrofurantoin Macrocrystals | USP/EP/IP | Antibiotic | Filed - 033523 | Approved | Available | Available |
15 | Commercial | Nitrofurantoin Monohydrate | IH/USP/IP | Antibiotic | Filed - 033351 | - | Available | Available |
16 | Commercial | Obeticholic Acid | IH | Primary biliary cholangitis | - | - | - | Available |
17 | Commercial | Pantoprazole Sodium Sesquihydrate | IP/USP/EP | Proton Pump Inhibitor | Filed - 035357 | Approved | Available | Available |
18 | Commercial | Propranolol HCl | USP/EP | Cardiovascular | Filed - 035635 | Approved | Available | Available |
19 | Commercial | Ranolazine | IH | Antianginal | Filed - 034571 | - | - | Available |
20 | Commercial | Revefenacin | IH | Anticholinergics | Filed - 036771 | - | - | Available |
21 | Commercial | Rosuvastatin Calcium | USP/EP | Antilipemic Agent | Filed - 036493 | Approved | - | Available |
22 | Commercial | Sacubitril Sodium | IH | Cardiovascular | Filed - 036204 | - | Available | Available |
23 | Commercial | Sacubitril Valsartan Trisodium (Amorphous) | IH | Cardiovascular | Filed - 036637 | - | Available | Available |
24 | Commercial | Sitagliptin Phosphate Anhydrous | IH | Anti-Diabetic | Filed - 035702 | - | - | Available |
25 | Commercial | Sugammadex Sodium | IH | CNS Agent | Filed - 033864 | - | - | Available |
26 | Commercial | Succinylcholine Chloride | IH | CNS Agent | Filed - 037245 | - | - | Available |
27 | Commercial | Telmisartan | IP/USP/EP | Acute Migraine | Filed - 036807 | To be Filed | - | Available |
28 | Commercial | Ticagrelor | IH/EP | Platelet Aggregation Inhibitor | Filed - 036711 | Approved | - | Available |
29 | Commercial | Ursodeoxycholic Acid | IP/USP/BP/EP | Anticholelithic | - | - | - | Available |
30 | Commercial | Valsartan Disodium | IH | Cardiovascular | Filed - 036203 | - | Available | Available |
*Please reach out to us for details related to filings in China, Brazil and Korea
Under Development/Validation Products
Sr. No. | Category | Product | Pharmacopoeia | Therapeutic Class/Indication | Initial Development | Lab Validation | Lab Sample | Plant Validation | DMF |
---|---|---|---|---|---|---|---|---|---|
1 | Under Development/Validation | Sitagliptin Phosphate Monohydrate | IH | Anti-Diabetic | ✓ | ✓ | ✓ | TBD | TBD |
2 | Under Development/Validation | Midodrine HCl | IH | Treatment of orthostatic hypotension | ✓ | ✓ | ✓ | Q2 2024 | Q1 2024 |
3 | Under Development/Validation | Rocuronium bromide | IH/USP/ EP | Non-depolarizing neuro-muscular drug | ✓ | ✓ | ✓ | Q1 2024 | Q1 2024 |
4 | Under Development/Validation | Cisatracuriu m Besylate | IH | Non-depolarizing neuro-muscular drug | ✓ | - | - | Q2 2024 | Q3 2024 |
5 | Under Development/Validation | L-Glutamine | IH | Sickle-cell anaemia | ✓ | - | ✓ | Q1 2024 | Q2 2024 |
6 | Under Development/Validation | Empagliflozin | IH | Anti-Diabetic | ✓ | ✓ | ✓ | Q4 2024 | Q1 2025 |
7 | Under Development/Validation | Netarsudil | IH | Treatment of intraocular hypertension | ✓ | - | Q1 2024 | Q1 2025 | Q2 2025 |
8 | Under Development/Validation | Latanoprost | IH | Treatment of intraocular hypertension | ✓ | - | - | Q2 2025 | Q3 2025 |
9 | Under Development/Validation | Latanoprost ene Bunod | IH | Treatment of intraocular hypertension | ✓ | ✓ | ✓ | Q2 2025 | Q3 2025 |
10 | Under Development/Validation | Fezolinetant | IH | Reduce symptoms of Menopause | ✓ | - | Q2 2024 | Q2 2025 | Q4 2025 |
11 | Under Development/Validation | Perfluorohex yloctane | IH | Dry eye Syndrome | ✓ | - | Q2 2024 | Q2 2025 | Q4 2025 |
12 | Under Development/Validation | Sacubitril Valsartan Trisodium (Crystalline) | IH | Cardiovascular | ✓ | - | ✓ | Q3 2024 | Q4 2024 |
*Please reach out to us for details related to filings in China, Brazil and Korea
Disclaimer: Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to development and submission of information under law regulating the manufacture, use or sale of drugs. It is within the buyer's responsibility and liability to check the patent situation of the product in the imported market (s)