CRO / CDMO (API & Intermediates)

Rushi Pharma offers integrated Contract Research, Development, and Manufacturing services for APIs and intermediates, supporting pharmaceutical and biotech partners from early-stage research to commercial scale.

Our Hyderabad-based R&D facility is supported by:

• 5 PhD-level scientists
• 30+ experienced research professionals
• Leadership with 25+ years of global industry experience
• International post-doctoral exposure

We operate through structured project teams led by dedicated scientific leaders.

Our Development Capabilities:

Research & Development:

• Route scouting and feasibility studies
• Process development and optimization
• New Chemical Entity (NCE) synthesis
• Peptide synthesis
• Analytical method development
• Salt & polymorph screening
• Impurity isolation and characterization

Project Models:

We support:

• Full-Time Equivalent (FTE) research projects
• Milestone-based development programs
• Custom synthesis (gram to multi-kilo scale)
• Process scale-up support

Quality & Technical Validation:

• Technical documentation review
• Pre-shipment samples
• Third-party analysis (if required)
• Ongoing technical coordination

Pilot & cGMP Capabilities:

• cGMP-aligned pilot plant
• Clinical trial material production
• Analytical development and validation support

We align our development processes with regulatory expectations to facilitate downstream compliance.

Contract Manufacturing:

As part of our long-term manufacturing strategy, Rushi Pharma has co-invested in a USFDA-compliant API manufacturing facility, strengthening our capability to support regulated market requirements.

This strategic investment enhances our ability to:

• Support cGMP-aligned production
• Facilitate regulated market documentation
• Ensure manufacturing transparency
• Strengthen long-term supply security

Through structured collaboration with qualified manufacturing partners, we provide development-to-commercialization continuity for APIs and intermediates.