RESEARCH & DEVELOPMENT
Our State of art laboratory is capable of producing novel synthetic routes for the synthesis of advance products. Our R&D team is composed of rich experienced organic chemists and technicians. These highly skilled and innovative staff specialize in all aspects of API process research, and Pharmaceutical Impurity synthesis and development.
Manufacturing Unit
The facility consists of different volumes of reactors ranging from 0.25 KL to 4.0 KL with all types of utility facilities which is suitable to carry the reactions like Catalytic hydrogenations, Chlorination’s Nitration’s, Alkylation’s, Oxidations, Reductions, Resolutions(chemical) , couplings etc…The unit is having well equipped clean room facility for finished product drying, milling, packing & storage
Technical Infrastructure
- Stainless Steel and GLR reactors with total reactor volume of 35 Kilo Liters (capacities ranging from 250 Lt to 4000 Lt)
- Temperature range: from – 20°C to 200°C
- Pressure range: Up to 20 Kg/cm3
- High vacuum distillation (Up to 1.5 Torr)
QA &QC
Quality control is independent of production. All the QC testing for Fne chemicals & intermediates are done in-house at the QC laboratory located on site. The laboratory is well equipped instrumentation including GC & HPLC. Quality unit is having independent authority for approval /rejection of material. Documents are prepared and upgraded time to time as per GMP guidelines like ICH Q7, and other international regulatory guidelines. Regular Internal Quality Audits and GMP Audits to ensure the continuous maintenance of Change control, Document control, Deviation handling, Complaint handling, Validation Qualification of Equipments and total Quality system. The unit is having good laboratory to conduct experiments on existing products and other new molecules development.