BioSpectra Inc. (BSI), is a privately-owned manufacturer of premium pharmaceutical ingredients and bulk, cGMP fine chemicals, in service to many leading BioPharma companies around the world. We offer innovative purification and synthetic capabilities to produce finished cGMP products, that serve to enhance every stage of the drug manufacturing process – upstream, midstream and downstream.
As a leader in cGMP manufacturing, our portfolio includes bulk GMP biological buffers, GMP Buffer Solutions, GMP process fine-chemicals, as well as new chemical entities (NCEs) produced at IPEC & ICH Q7 regulatory compliance levels. We specialize in small molecule synthesis and true, phase-change multi-step purification, providing solutions for various cGMP key ingredient issues at various stages of the drug manufacturing process.
Purification
GMP Solutions
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured – FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.