Regulatory Affairs ensures compliance with national and international regulatory requirements.

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 the regulated markets. Our facilities have been successfully audited by US-FDA and European Agencies. We have filed and received approval of some of our ANDAs and COS from respective Regulatory agencies.