BioSpectra Announces Expansion of Parenteral Ingredient Manufacturing Capacity
BioSpectra has expanded its capacity for the synthesis and purification of APIs and Excipients with Low Bioburden and Low Endotoxin (LBLE) requirements. These products are intended for further use in Parenteral Drug Applications and are manufactured with demanding specifications utilizing BioSpectra’s advanced manufacturing and purification systems, stringent environmental controls, strict process monitoring, robust quality and compliance programs and comprehensive finished product testing. The intended product offering includes LBLE Excipients: Galactose, Sucrose and Trehalose.
Additional APIs and Excipients are being manufactured under proprietary contract agreements and will be among the products launched this year and added to the existing line. US FDA registered and inspected, BioSpectra exclusively manufactures all its products at state-of-the-art GMP facilities in Bangor and Stroudsburg PA, USA. Products include premium APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions. In addition, BioSpectra offers a range of contract, custom GMP manufacturing services and Lab support.
For more information our team of specialists can be found at Booth #625.