Corporate Profile

What We Do

BioSpectra manufactures cGMP fine chemicals for use in pharmaceutical processes as well as finished drug products used by global BioPharma, Bio-CMOs and Biochemical companies. This includes cGMP bulk biological buffers, cGMP large volume bio-buffer solutions, cGMP process fine chemicals, cGMP chlorinated amino acids, parenteral grade carbohydrates and carbohydrate (Dextran) polymers, as well as other novel and compendial excipients.

Who We Are

BioSpectra is an end-to-end producer of raw materials and manufacturer of the highest purity cGMP fine chemicals for biopharmaceutical applications.
Our base of cGMP manufacturing is at our FDA registered, cGMP facilities in Bangor and Stroudsburg, PA, USA.
We can offer long-term fixed pricing to shield against fluctuations.
We are absolutely the best at supporting new qualifications via documentation, samples, and audits.

For further information, please contact Paul Dimarco at paul.dimarco@biospectra.us.

cGMP Product Categories

cGMP Process Chemicals
Bulk Custom Solutions
Bulk Biological Buffers
Functional Expedients
Active Ingredients

Comprehensive Quality & Regulatory System

FDA Registered & Inspected
Full Transparency in Documentation
Stringent Quality Program & Controls
Document Support – DMF Submissions
Rigorous compliance to Global Standards
FDA & ICH Q7 Guidance for Drug Substances
Global GMP Requirements – US, IPEC, ICH Q7
State-of-the-art Instrumentation & Laboratories
Culture of Embracing Evolving Regulatory Demands

Corporate Values & Commitments

True cGMP Product Claim
Reliable, Consistent, Uniform, Quality-Based Manufacturing of Premium Pharmaceutical Ingredients
Authentic, Secure Supply Chain - 100% Traceable Raw Materials from Qualified Sources
Fully Validated cGMP Manufacturing Systems & Qualified Equipment