BioSpectra

About BioSpectra

BioSpectra Inc. (BSI), is a privately-owned manufacturer of premium pharmaceutical ingredients and bulk, cGMP fine chemicals, in service to many leading Bio Pharma companies around the world.  We offer innovative 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 cGMP biological buffers, cGMP Buffer Solutions, cGMP process fine-chemicals, as well as new chemical entities (NCEs) produced at IPEC & ICH Q7 regulatory compliance levels. 

  • Country/Region:
    United States
  • On CPHI since:
    2017
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
Pharmaceutical company
Primary activities
Excipients Manufacturer
Contact info
Meet us at

CPHI Milan 2026

Fiera Milano, Italy
6 Oct 2026 - 8 Oct 2026

Products from BioSpectra (27)

  • New Chemical Entities (NCE's)

    Product New Chemical Entities (NCE's)

    e.g. 2-MEA, Sodium Decanoate, MES, MOPS, and more
  • Biotech Product Line

    Product Biotech Product Line

    • Secure, Sustainable Supply Chain • Package sizes from 100 g to 50 kg • Seamless Scale Production • Manufactured Under Full cGMP Conditions • Specs combined to meet the needs of the Bio Tech and Bio Pharma markets
  • Potassium Bromide API

    Product Potassium Bromide API

    Potassium Bromide is used as an active substance in veterinary medicine as an anti-seizure medication. Bio Active Grade Potassium Bromide is suitable for use as a non-Sterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH Q7 Good Manufacturing Practice Guide. This grade of Potassi...
  • Tromethamine (TRIS) API

    Product Tromethamine (TRIS) API

    Bio Active Grade of Tromethamine is intended to be used in parenteral drug formulations as an Active Pharmaceutical Ingredient. This product is not to be considered sterile and requires further terminal sterilization. The manufacturing of Tris/Tromethamine, TRIS-2255 is performed at BioSpectra's Bango...
  • Guanidine Hydrochloride 6M Solution, cGMP Excipient

    Product Guanidine Hydrochloride 6M Solution, cGMP Excipient

    Guanidine Hydrochloride 6M Solution is suitable for use as a cGMP chemical in pharmaceutical manufacturing processes. It can be used to denature proteins which become randomly coiled with no residual structure. This concentration is also used to decrease enzyme activity. The denatured proteins can be modif...
  • D-Galactose (Plant Derived), cGMP Excipient

    Product D-Galactose (Plant Derived), cGMP Excipient

    D-Galactose, plant derived, is suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products. It is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose, BioSpectra has categorized our product as an excipient though one of the pr...
  • Guanidine Hydrochloride, cGMP Excipient

    Product Guanidine Hydrochloride, cGMP Excipient

    Guanidine Hydrochloride is suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products. It is a strong protein denaturant that functions as a chaotropic agent. As a denaturant, it acts to unfold proteins and turn them into their original polypeptide chains. As a chaotropic ag...
  • Guanidine Thiocyanate, cGMP Excipient

    Product Guanidine Thiocyanate, cGMP Excipient

    Guanidine Thiocyanate is a chaotropic agent, suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products. As one of the strongest protein denaturants, it inactivates nucleases more efficiently than Guanidine Hydrochloride. Guanidine Thiocyanate is preferred for the purificati...
  • HEPES (Free Acid), cGMP Excipient

    Product HEPES (Free Acid), cGMP Excipient

    Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products. HEPES is a zwitterionic buffer used to maintain pH of media used in cell cultures. It is one of Good’s buffers that has a pKa value similar to its pH value, making it an ideal buffer for pH maintenance. A known limi...

BioSpectra Resources (4)