Pharmaceutical Development

• Thorough understanding in pharmaceutical development of various drug candidates, dosage forms and delivery systems in compliance with global regulatory requirements.
• Experience in working on specific challenges, such as improvement of solubility and bio availability, release control targeted delivery and taste masking
• Development of a robust formulation by evaluating the impact of formulation and critical material/process variables on drug product quality attributes during the lab scale development to establishing the “Design Space”.
• Technology transfer from lab Scale to production scale and validation of unit process.
• Experience and expertise in addressing regulatory deficiencies for different regulatory agencies.
• Time and cost being the most important aspects of generic market, we aim for cost effective and timely development of generic products.

Development Activities

• Literature Search
• Pre-formulation Studies: Drug substance characterization, Comprehensive excipient screening and selection
• Prototype development
• Formulation and Process Optimization
• Stage wise documentation and technical data package
• Submission & Post submission regulatory support.

List of Equipment’s & Instruments:

Equipment(s)	Instruments in IPQC
Vibratory sifter	UV / visible spectrophotometer
High shear mixer granulator	Halogen moisture balance
Fluid bed dryer / processor	Tablet hardness tester
Multi mill & Kalweka multippurpose drive	Ph meter
Blender(s)	Weighing balance(s)
Compression machine: Multi tooling with Bilayer option.	Tapped density apparatus
Tablet auto coater & Conventional coating pan	Disintegration tester
Ika homogenizer & mixers	Vertical Franz Diffusion Cells
Capsule filling machine	Viscometer: QC 300 R with Peltier Device.
Blister Packing Machine & Induction sealing	Dissolution apparatus I & II
Transdermal coater	Modified USP II Dissolution apparatus (Enhancer cell)