Active Pharmaceutical Ingredients, engineered with process discipline.
Our API division synthesises bulk active ingredients under stringent process controls, backed by full analytical DMF documentation to support regulatory filings in India and international markets.
Regulatory Ready Dossiers
DMF Filing SupportFull analytical validation, impurity profiling, and ICH stability packages prepared to support your market filings.
Process capabilities built for regulated bulk supply.
Multi-purpose reactors
Glass-lined & SS 316L reactors sized from pilot batches to commercial volumes.
Analytical R&D
Method development, validation protocols & genotoxic impurity profiling.
Process validation
Scale-up protocols with documented batch-to-batch process consistency.
DMF documentation
Drug Master File preparation and active regulatory support for customer filings.
Effluent & solvent recovery
Environmentally compliant closed-loop solvent recovery & ETP systems.
Bulk packaging
HDPE drums, fibre drums & validated temperature-controlled logistics.
Documentation built to support your filing timeline.
Our regulatory affairs team works alongside customers from early feasibility through commercial supply — providing analytical data and stability packages expected by authorities.
Certificate of Analysis (CoA) provided with every batch shipment
Real-time & accelerated stability packages aligned to ICH guidelines
Comprehensive impurity profiling & genotoxic impurity assessment
Site Master File (SMF) access and support for partner quality audits
Plant capabilities at a glance.
| Reactor capacity | Multi-purpose SS 316L & glass-lined reactors from pilot to commercial-scale volumes |
| Documentation | DMF Dossiers, CoA, ICH stability data & site master files upon request |
| Certifications | WHO-GMP · ISO 9001:2015 · ISO 14001:2015 · Environmental Board Clearance |
| Quality control | Dedicated analytical R&D laboratory with HPLC, GC, and impurity testing capabilities |
| Supply terms | Ex-works and CIF terms available for domestic and international export shipments |