API
Cardiovascular APIs
ACE inhibitors, ARBs, statins, beta-blockers
Full synthetic route development and multi-tonne commercial manufacture of cardiovascular active pharmaceutical ingredients. DMF filing support included.
ICH Q7DMF Ready0.1–10 MT
API + Finished
Oncology & HPAPI
Cytotoxics, kinase inhibitors, targeted therapies
Potent compound handling to OEB-5 standards with isolator technology. Dedicated suite with full containment, ISPE SMEPAC-compliant.
OEB-5Contained MfgADC Ready
Sterile
Sterile Injectables
Aseptic vials, prefilled syringes, lyophilized
RABS and isolator-based aseptic fill/finish. 15M vials/year capacity. Automated inspection with 100% vision system.
ISO Class 5Lyophilization15M vials/yr
Oral Solid
Tablets & Capsules
Immediate & modified release, film-coated
High-speed Fette compression to 2B tablets/yr. Fluid bed granulation, roller compaction, spray coating with full PAT integration.
2B tabs/yrPAT EnabledMR Capable
Analytical
Analytical Services
Method development, validation, stability
Full analytical method development and ICH-compliant validation. HPLC, LC-MS/MS, GC, dissolution, particle size analysis.
ICH Q221 CFR Pt 11Stability
Development
Formulation Development
Pre-IND through Phase III, tech transfer
End-to-end formulation development with integrated CMC regulatory writing. Solubility enhancement, bioavailability optimization, QbD approach.
QbDCMC WritingTech Transfer