BioSpectra  

Bangor,  PA 
United States
https://www.biospectra.us/

• Booth: 625

BioSpectra manufactures premium, GMP Pharmaceutical Ingredients exclusively in the USA: APIs / Excipients / GMP Process Chemicals & Solutions / High Purity, GMP, Bulk Biological Buffers & Denaturants / GMP Contract Manufacturing of APIs, Excipients & Process Chemicals.

FDA Registered and Inspected, ICHQ7, IPEC & US-GMP Compliant. 175,000 square feet of state-of-the-art GMP manufacturing and storage facilities.

We focus on solving ingredient issues through custom synthesis, purification and GMP product development.

Our goal is to become a valued partner in your secure supply chain and the solution to key ingredient issues you may have.

 Videos

 Press Releases

• BioSpectra Announces Expansion of Parenteral Ingredient Manufacturing Capacity (Apr 04, 2018)

  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.

• BioSpectra announces expanded Lab Services (Apr 04, 2018)

  BioSpectra has expanded its Quality Control contract lab services portfolio to include ICP-MS analysis of elemental impurities for independent customer requests.

  BioSpectra's Quality Control Lab Services continues to expand beyond its original role of supporting internal raw material and finished product testing to include independent customer requests. A focal point is ICP-MS analysis of elemental impurities required under USP General Chapters <232> and <233> for all APIs and Excipients. BioSpectra’s expanded Quality Control staff has received extensive training in the validation, testing and application of the USP General Chapters and ICH Q3 Guidelines. Other lab services are also being made available on an independent, contractual basis.

   

  FDA registered and inspected, BioSpectra exclusively manufactures all its products at its state-of-the-art GMP facilities in the USA. Products include premium APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions.

  For more information our team of specialists can be found at CPhI Philadelphia, April 24-26th, Booth #625. Call or contact us for an appointment today or just stop by to learn more!

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