We offer our clients high quality formulation development services for the regulated markets in the US and the European Union (region). The facility houses a state-of-the art formulation development laboratory, an analytical laboratory and a cGMP certified pilot plant.
Complete data integrity with proper documentation practices
Good Laboratory Practices followed for all activities
The Analytical Laboratory is equipped with the following major equipment’s:
HPLC’s from Waters and Agilent with UV, PDA and RI detectors
Dissolution baths with auto samplers
UV-Vis spectrophotometer
Infra-red spectrophotometer
Auto-titrator
Malvern Mastersizer® for particle size analysis
Osmometer from Advanced Instruments, USA
Hardness tester from Erweka
STABILITY
Stability samples maintained at different conditions as per ICH guidelines: 25ºC/60%RH; 30ºC/75%RH; 40ºC/75%RH
Photo-stability chamber
All chambers are GMP-design with insides of SS 316
Stand-by refrigeration and de-humidification system
Continuous monitoring of temperature and humidity
Alarm system with GSM mobile communication / audio alarm
Sample testing as per appropriate stability specifications
ANALYTICAL LAB
The analytical lab is staffed by trained chemists, material scientists, technicians, and laboratory management with years of industry knowledge and expertise.