Regulatory Affairs
We possess capabilities for preparing ANDA in eCTD, Technical Dossiers and Drug Master Files (DMFs) for a range of our products. Our facilities are constantly upgraded to comply with European and US Regulatory inspections, making us strategically poised to enter regulated markets. Our facilities have been successfully audited by US-FDA and European Agencies. We have filed and received approval of some for our ANDAs and COS from their respective Regulatory agencies.
Regulatory Filings by Alembic Limited
| Cumulative US DMFs Filed | 53 |
| Cumulative ANDA Filed | 38 |
| Cumulative CoS Filed | 14 |
| ANDA Approval Received | 15 |
Drug Product Manufacturing Facility |
API Facility has been Audited and Approved by |
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Research & Development
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