With management cutting back on R & D resources, we understand the intense need to create optimal formulations under tight timelines with a limited amount of API. And therefore any formulation development project that is undertaken starts with a thorough analysis of the Preformulation data report, the intended manufacturing process, any patient compliance issues and the strategic goals of the sponsor company.

Our logical, data-driven approach to formulation development gives the compound the best chance at success and provides our clients the most efficient, straightforward process for manufacturing the compound.

Our Formulation Development team undertakes work on new active substances, generics and reformulation of existing products. Our facility with Class 100,000 GMP area and conforming to cGMP offers following services:

• Pre- Formulation
• Formulation of wide variety of dosage forms
• Analytical method development & validation
• Stability studies as per ICH guidelines
• Product development report
• Documentation in CTD format
• Process validation and technology transfer
• Preparation of DMF / COS

Formulation development includes the Solids, Liquids and Semi-solids dosage forms. The facility is fully equipped to develop Sustained release and Controlled release formulations with state of the art technology & equipments to include Auto coater and fluid bed coater. A well-equipped Analytical development lab will support the formulation development process.

The major equipments in solid oral dosage form are-

• V blender ( Globepharm, USA )
• Rapid Mixer Granulator
• Bilayer tabletting machine
• Neocoata Autocoater
• Fluid Bed Processor

Analytical Development
Analytical Section is divided into different areas like Instrumentation, Chemical analysis, Stability, Microbiology.

The major instruments in analytical section are–

• Agilent HPLC systems (Quaternary Gradient System with autosampler and UV/PDA detector)
• Shimadzu UV Spectrophotometer (with variable band width)
• Gas Chromatograph with Head Space (FID/ECD Detector)
• Automated Dissolution Testers
• Water Purification System with Online TOC Analyzer
• Stability Cabinets
• Microbalance ( 5mg – 21g )

Microbiology Section is divided into two major sections Sterility and Microbial limit testing. This section has following infrastructure-

• Entry Through airlocks / change rooms
• Air Handling System ( Class 10,000)
• Laminar air flow with HEPA ( Class 100 )
• Material Transfer through pass boxes
• Horizontal Autoclave with double door
• Separate Sections for Sterility /MLT testing
• BOD Incubators

Analytical and Formulation development operations are GLP and GMP compliant.