Contract Research & Manufacturing Services (CRAMS)
Sun Pharma, being a trusted partner for many leading innovator and generic companies and having proven track record on “chemical process development & manufacturing”, has ventured into CRAMS. With unwavering commitment to quality, state-of-the-art research, global manufacturing capabilities, regulatory and intellectual property (IP) expertise, we are geared up to support and accelerate the development and manufacturing programs of global innovator companies for Novel Chemical Entities (NCEs).
We offer the following services under CRAMS:
- Synthetic Route Design & Scouting Services including flow chemistry
- High-end Chemical Process Development (DoE, 6s, QBD, Salt & Polymorph) & lab demonstration
- Process Engineering (Data Generation) & Process Safety Studies (Process Hazard Analysis)
- Salt Screening and polymorph studies
- Impurity Profiling (including impurity & reference standard synthesis)
- Kilo & Pilot Scale Manufacturing (non-GMP & GMP) TOX and Clinical Quantities
- PAR (Proven Acceptance Range) & NOR (Normal Operating Range) Studies
- Process Validation followed by Commercial Manufacturing
- ICH Stability Studies & Support for Regulatory filing and approvals (CMC, DMF)
Please write to us at email@example.com for any further queries.