Corporate Profile
BioSpectraTM is a manufacturer of cGMP Fine Chemicals, located in Stroudsburg, Bangor and Wind Gap, PA, USA. We own and operate seven facilities in the USA: two cGMP manufacturing sites, our cGMP warehouse and Supply Chain Center (SCC), and other Lab, Storage and Support facilities. In addition, BioSpectra oversees key raw material production and R&D operations in Canada, India and China – all under stringent quality oversight with full traceability and transparency of all raw material sources.
BioSpectra manufactures a unique line of cGMP Fine Chemicals for use in pharmaceutical processes and finished drug products used by global BioPharma, Bio Contract Manufacturers a.k.a. Bio-CMOs (for APIs and Finished Drug Products), and Biochemical Companies. This includes bulk Biological cGMP Buffers, large volume cGMP Bio-Buffer Solutions, cGMP Process Fine Chemicals, cGMP Chlorinated Amino Acids, highly purified Parenteral Grade Carbohydrates and Carbohydrate (Dextran) polymers, as well as other novel and compendial Excipients.
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Corporate Overview
- Active Substances
- GMP Custom Products
- Excipients and Key Ingredients
- GMP Process Chemicals and Solutions
- Bulk, GMP Biological Buffers & Denaturants
- 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
- Complete Testing of all Raw Material and Finished Products
- Purification of Key Ingredients
- Full GMP Product Development
- Small Molecule Custom Synthesis
- API Development & Manufacturing
- GMP Compounded Solvents & Solutions
- FDA Registered and Inspected
- Document Support - DMF Submissions
- FDA & ICH Q7 Guidance for Drug Substances
- GMP Process Chemicals and Solutions
- Global GMP Requirements – US, IPEC, ICH Q7
- State-of-the-art Instrumentation & Laboratories
- True GMP Product Claim – Always Synthesized and/or Purified not simply tested and repackaged
- Reliable, Consistent, Uniform, Quality-Based Manufacturing of Premium Pharmaceutical Ingredients
- Authentic, Secure Supply Chain - 100% Traceable Raw Materials from Qualified Sources
- Fully Validated GMP Manufacturing Systems & Qualified Equipment
- Exclusively Manufactured in the USA
Organizational Profile
Staff: 200+ Employees
Phone: 610-599-3400
More Info: www.biospectra.us
Pharmaceutical Ingredient Manufacturing:
Bulk Manufacturing Facility & Head Corporate Offices: Administration,
Regulatory Affairs, Quality Assurance & Quality Control
Address: 100 Majestic Way
Bangor, PA 18013
Staff: 125+ Employees
Site: 150,000+ sq. ft. on 37+ Acres
Corporate Services Center:
Commercial, IT, HR, & Finance Offices, Training Center
1349 Jacobsburg Road
Wind Gap, PA 18091
Staff: 30+ employees
Site: 25,000+ sq. ft. on 2+ Acres
Biological Buffer Manufacturing:
Bulk Manufacturing Facility, Quality Control and Assurance
Address: 1474 Rockdale Lane
Stroudsburg, PA 18360
Staff: 50+ Employees
Site: 25,000+ sq. ft. on 3+ Acres
Supply Chain Center:
Shipping and Receiving & Security Headquarters
Address: 51 North 3rd Street
Stroudsburg, PA 18360
Staff: 20+ Employees
Site: 60,000+ sq. ft. on 2+ Acres
Biospectra Canada
d.b.a & Dextran Products
Address: 421 Comstock Road
Scarborough, ON MIL 2H5, Canada
Fulmer:
BioBuffer Solutions Wet Chemistry Labs / Raw Material Warehousing
Under Construction - Completion 2025
Address: 51N 3rd Street, Stroudsburg, PA 18360