Founded in 1993 in Pennsylvania’s Poconos foothills, BioSpectra manufactures high-purity pharmaceutical ingredients, with a particular focus on validated cGMP biological buffers and fine chemicals for biopharmaceutical production. The privately owned company has grown into a multi-plant operation with more than 300 employees and facilities in the United States and Canada, while keeping its bulk GMP manufacturing exclusively in North America. BioSpectra’s Pennsylvania sites include dedicated biological-buffer production, pharmaceutical-ingredient manufacturing, and a 60,000-square-foot GMP storage facility.
ICH Q7
certification
FDA Registered
registration
IPEC & US GMP Compliant
compliance_program