Formulations CRO

Rushi Pharma offers integrated formulation development and technology transfer services for Finished Dosage Forms (FDF), supporting pharmaceutical companies from development through commercialization.

Our Capabilities:

Formulation Development:

• Pre-formulation studies
• Prototype development
• Dissolution method development
• Compatibility studies
• Stability studies
• Optimization of manufacturing process

We support development of solid oral dosage forms and other formulations based on client requirements.

We provide structured formulation technology packages including:

• Literature review and product strategy
• Quality Overall Summary (QOS)
• Drug substance and drug product specifications
• Manufacturing process and batch formula
• Critical process parameter controls
• Excipients and raw material specifications
• In-process and finished product specifications
• Analytical testing procedures
• Stability data
• Packaging specifications
• Bioequivalence summaries (where applicable)

Our documentation approach is structured to support regulatory filings where required.

Technology Transfer Support:

We assist clients with structured tech transfer programs, including:

• Demonstration batches
• Exhibit batch execution
• Process validation support
• On-site coordination

Outright Sale of ANDA’s:

We facilitate structured transfer of ownership for selected ANDA dossiers, including documentation transfer and technical support.