BioSpectra, Inc. Information

BioSpectra is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including actives, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our focus is small molecule synthesis and true, phase-change multi-step purification for both traditional and biopharmaceutical applications. Our services include contract GMP product development, coupled with ongoing commercial manufacturing and regulatory support, up to and including DMF submissions. All of our manufacturing processes are fully validated. Our U.S.-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Onsite analytical testing capabilities include multi-compendial and custom specifications, with full traceability and transparency of all raw materials and sources. Our commitment to quality, compliance and true, U.S.-GMP manufacturing, testing, and regulatory support is unparalleled. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have. GMP Product Categories: • Bulk GMP biological buffers • Active & functional excipients • GMP process chemicals and bulk GMP Solutions Custom GMP Services: • Purification of key ingredients • Full GMP product development • Small molecule custom synthesis • API development and manufacturing • Custom GMP compounded solvents and solutions Comprehensive Quality and Regulatory Program: • FDA registered and inspected • Document support (DMF submissions) • Global GMP requirements (US, IPEC, ICH-Q7)