Contract Development & Manufacturing (CRAMS)
We support drug development and API manufacturing programs, including the KSM & Key Intermediates for global pharmaceutical companies at all stages from pre-clinical stage to commercialization. We aspire to provide an efficient, compliant, cost-effective and long-term commercial drug substance solutions for our strategic partners
1. Contract Development & Manufacturing
a) Drug Substance Services
- Chemical process development (Pre-clinical to P-III/Commercial)
- Drug substance manufacturing
- CMC support
- Custom synthesis
b) Analytical Development Services
- Method Development & Validation
- Wet Chemistry and Compendial tests
- Stability studies as per ICH guidelines
- Impurity identification, characterization
c) Contract Manufacturing Services
- Tech transfer and Scale up Management
- Key Starting Materials
- Drug Intermediates
- Active Pharmaceutical Ingredients (APIs)