SKALAR PHARMA CDMO, GUAYAMA SITE, PUERTO RICO, US. | SKALAR PHARMA CDMO, Puerto Rico
SKALAR PHARMA CDMO, GUAYAMA SITE, PUERTO RICO, US. | SKALAR PHARMA CDMO, Puerto Rico
Puerto Rico
QUALITY & REGULATORY EXCELLENCE • FDA cGMP aligned (21 CFR Parts 210 & 211) • ICH Q7 compliant operations • Comprehensive Quality Management System • CAPA and C
About the Plant
OVERVIEWSkalar Pharma operates one of the most established API manufacturing facilities in Puerto Rico, originally developed by AstraZeneca in 1992 and subsequently operated by Eli Lilly. Today, the facility combines decades of cGMP manufacturing experience with modern capabilities in complex chemistry, HPAPI handling, process development, pilot-scale operations, and commercial manufacturing.The integrated platform supports the complete lifecycle of pharmaceutical development, from laboratory process development through commercial-scale API production.CORE TECHNOLOGIES• Complex heterocyclic chemistry• Fluorinated compounds• High-potency APIs (HPAPI)• Multi-step synthetic processes• Hazardous reaction management• Nitrations• Hydrogenations• Controlled oxidations• Cryogenic chemistry• Continuous flow chemistry• Particle size engineering and micronizationSPECIALIZED CAPABILITIESHPAPI Manufacturing (OEB4)Dedicated containment systems support the safe development and manufacture of highly potent compounds required for oncology and other specialized therapeutic areas.Advanced Materials of Construction• Hastelloy reactors• Glass-lined reactors• Stainless steel reactorsThese assets enable the safe handling of corrosive chemistries, fluorinated processes, highly acidic media, and demanding reaction conditions.Micronization PlatformNitrogen jet micronization systems provide precise particle size control for specialized APIs and advanced pharmaceutical applications.DEA Licensed OperationsDEA Schedule II-V licenses support research, analysis, importation, manufacturing, and handling of controlled substances, creating a significant regulatory and operational advantage.