
Markets
FY, 2024
Drug Master Files Filed (Emerging Markets)
FY, 2024
Drug Master Files Filed (India)
FY, 2024
| Metrics | FY, 2022 | FY, 2023 | FY, 2024 |
|---|---|---|---|
| Markets | 86 | 85 | 78 |
| Drug Master Files Filed (Emerging Markets) | 544 | 410 | 426 |
| Drug Master Files Filed (India) | 2 | 4 | 3 |
| Drug Master Files Filed (Europe) | 16 | 18 | 47 |
| Drug Master Files Filed (South Africa and Global Access) | 6 | 11 | 6 |
| Drug Master Files Filed (United States) | 12 | 15 | 19 |
| Drug Master Files Filed | 583 | 458 | 503 |
| Dossiers Filed (Australia and New Zealand) | 12 | ||
| Dossiers Approved | 275 | 270 | 333 |
| Dossiers Approved (Emerging Markets) | 87 | 115 | 111 |
| Dossiers Approved (South Africa and Global Access) | 97 | 112 | 85 |
| Dossiers Approved (Europe) | 49 | 30 | 120 |
| Dossiers Approved (United States) | 13 | 6 | 5 |
| Dossiers Filed (South Africa and Global Access) | 195 | 100 | 72 |
| Dossiers Filed (Europe) | 16 | 14 | 14 |
| Dossiers Filed (United States) | 12 | 13 | 13 |
| Dossiers Filed (India) | 38 | 12 | 19 |
| New Drug Application Portfolio (Tentatively Approved) | 12 | 12 | 12 |
| New Drug Application Portfolio (Approved) | 4 | 6 | 6 |
| Dossiers Approved (Australia and New Zealand) | 7 | ||
| Dossiers Approved (India) | 22 | 7 | 12 |
| Manufacturing Capacity (Lyophilised Injections) | 11.5M | 1.6M | 1.9M |
| Manufacturing Capacity (Oral Liquids) | 51.2M | 51.6M | 51.6M |
| Manufacturing Capacity (Aerosol pMDI) | 144.2M | 125.8M | 129.1M |
| Manufacturing Capacity (Respules) | 750M | 773.6M | 726.9M |
| Manufacturing Capacity (Nasal Sprays) | 50.6M | 48M | 43.2M |
| Manufacturing Capacity (Tablets and Capsules) | 32.7B | 30.5B | 28.3B |
| Products | 1.5K | 1.5K | 1.5K |
| Dosage Forms | 50 | 50 | 50 |
| Manufacturing Sites | 47 | 47 | 46 |
| Products Launched (Emerging Markets) | 15 | 27 | 44 |
| Products Launched (India) | 10 | 12 | 14 |
| Products Launched (Europe) | 20 | 20 | 20 |
| Products Launched (South Africa and Global Access) | 32 | 10 | 10 |
| Products Launched (United States) | 16 | 9 | 13 |
| Products Launched Yearly | 93 | 78 | 101 |
| Therapeutic Categories | 65 | 65 | 65 |
| Dossiers Filed | 423 | 270 | 270 |
| Dossiers Filed (Emerging Markets) | 150 | 115 | 151 |
| Suppliers | 8.6K | 8.7K | 8.3K |
| Critical Suppliers (Tier 1) | 433 | 597 | 571 |
| New Drug Application Portfolio (Under Approved) | 3 | 3 | 4 |
| New Drug Application Portfolio | 19 | 21 | 22 |
| Abbreviated New Drug Application Portfolio (Under Approved) | 19 | 71 | 77 |
| Abbreviated New Drug Application Portfolio (Tentatively Approved) | 66 | 19 | 20 |
| Abbreviated New Drug Application Portfolio (Approved) | 165 | 155 | 158 |
| Abbreviated New Drug Application Portfolio | 250 | 245 | 255 |
| Abbreviated New Drug Applications Approved | 12 | 7 | 5 |
| Abbreviated New Drug Applications Filed | 11 | 14 | 12 |
| Drug Master Files Filed (Australia and New Zealand) | 3 | ||
| Manufacturing Capacity (Form Fill Seal Eyedrops) | 2.5M | 2.5M | 700K |
| Clinical Trials Initiated | 23 | 31 | |
| Molecules Evaluated | 50 | 40 | |
| Drug Master Files Filed (China) | 2 | ||
| Clinical Trials Completed | 10 | ||
| Dossiers Filed (China) | 1 |
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Source:CSRHub