BioSpectra, Inc.

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USABioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical 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 US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources. Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. 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 Solution Solutions Custom GMP Services Include:• Purification of Key Ingredients• Full GMP Product Development• Small Molecule Custom Synthesis• API Development & Manufacturing• Custom GMP Compounded Solvents & SolutionsComprehensive Quality and Regulatory Program• FDA Registered and Inspected• Document Support - DMF Submissions• Global GMP Requirements – US, IPEC, ICH Q7