● To comply with USFDA / EU GMP / ICH & PIC/S Guidelines ● To focus on our core competency in sterile formulation manufacturing - Liquid
Injections, Lyophilized Injections & ophthalmic preparations ● To ensure highest quality of medicines with ultra-modern, automated equipments.
Key features of our new facility
● State of Art facilities with high automation in manufacturing, filling, lyophilization, inspection and packing ● Vial line with speed of 300 vials per minute. ● Latest Lyophilizes with high capacity: 400 ice capacity or 20 m2 and 2 units each with Automated Guided Vehicle (AGV) for uninterrupted loading
and unloading of lyophilized vials ● Ampoule line with speed of 550 ampoules per minute ● Eye drop line with speed of 100 units per minute ● Fully automated Manufacturing lines with 21 CFR compliance. ● Automated Sterilization equipments with 21 CFR compliance. ● Automated inspection and packing Lines ● Automated inspection and packing Lines ● High quality HPL clean room Partitions ● S S Air handling units as per classification required with VFD Screw chillers and BMS. ● Dynamic pass boxes. ● State of Art fully equipped Microbiology and Sterility Department ● Walk in Stability Chambers with PLC control and 21 CFR compliance. ● Fully equipped Quality Control Laboratory with data integrity compliance. ● Fully Automated Purified water and Multicolumn Distillation and Pure Steam Generator with high output and data integrity compliance. ● Screw technology non lubricated air-compressors. ● Rain Water Harvesting. ● Fire Hydrant Systems with Alarms and Safety features.
● Proton Pump Inhibitors ● Anesthetic Products and Muscle Relaxants ● Antifungals ● Antibiotics ● Niche and Orphan Products.
Our Services for Regulated Markets
● Site Transfer & Contract Manufacturing ● Technology Transfer and Manufacturing ● In-licensing and Out-licensing ● Contract Development / Co-development and Manufacturing