BioSpectra

About BioSpectra

BioSpectra manufactures the highest quality, highest compliance, bulk, GMP Biological Buffers and Denaturants in the only truly dedicated, USFDA registered & inspected, GMP facility. In addition, we offer contract, GMP small molecule synthesis for APIs, Excipients & key Intermediates; Solvent and Solution Compounding and Purification of critical GMP Process Fine Chemicals in small and large scale quantities, exclusively manufactured at our facilities in the USA under full GMP development. We operate 175,000 square feet of privately owned GMP manufacturing and storage space, under the most rigorous quality system, while holding to the most stringent regulatory demands including ICHQ7 and IPEC requirements. With our commitment to quality and compliance, GMP manufacturing that includes synthesis, purification, compounding and compliance support- up through and including Drug Master File submissions, our goal is to become a valued partner in your secure supply chain and the solution to any key ingredient issue you may have.

  • US
  • 2017
    On CPHI since
Contact info
Meet us at

CPHI Korea 2024

COEX, Seoul, Korea
27 - 29 August 2024

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024

Products from BioSpectra (15)

BioSpectra Resources (3)

  • News Bulk cGMP Fine Chemical Manufacturing - Biospectra Infographic

    Biospectra introduces their expertise in fine chemical manufacturing in this latest infographic, highlighting their ability to provide key ingredients and specialised solutions.
  • News BioSpectra Launches New product, 6M Urea GMP

    BioSpectra is adding to its line of GMP products, a 6M Urea, Large Volume, GMP Solution, manufactured from multicompendial GMP urea and water for injections.  This product will be manufactured in our new class 7 suite located in Bangor PA. Batch sizes are 7,000 liters.

  • News BSI’s Kilo-GMP Expansion in Rensselaer NY

    Renovations are nearly completed on our new, 10,000 sq. ft.  GMP Kilo-Scale facility in Rensselaer NY. Paired with our R&D and non-GMP kilo-scale labs, BSI is adding seven new Kilo-Scale, small molecule synthetic and purification suites for the development and manufacture of small volume API's and other critical small molecules used in the growing Bio Pharmaceutical market.  The first suites for GMP Kilo Scale will launch by end of year 2021!