Corporate Profile
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multistep purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources. Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, operating under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.
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
BioSpectra offers
BioSpectra offers four different grades of its materials from two manufacturing sites in Pennsylvania. Each grade of material is manufactured to meet specific end-use needs.
Bio Active Grade products are manufactured in our Bangor, PA facility, which is registered and inspected by the Federal Food and Drug Administration, in accordance with ICH Q7 guidelines incorporating qualified equipment and utilities, validated processes and fully traceable supply chains. Type II Drug Master Files may be referenced through a supply agreement.
Bio Excipient Grade products manufactured in accordance with ICH Q7 guidelines and Bio Pharma Grade products manufactured in accordance with IPEC guidelines are produced in our Bangor, PA and Stroudsburg, PA facilities.
Bio Active LBLE Grade products are intended for use in sterile applications. These products are manufactured in our Bangor, PA facility, which is registered and inspected by the Federal Food and Drug Administration, in accordance with ICH Q7 guidelines incorporating qualified equipment and utilities, validated processes and fully traceable supply chains. Type II Drug Master Files may be referenced through a supply agreement.
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
Fleet Services:
Address: Murray St.
Bangor, PA 18013
Staff: 3 Employees
Site: 5,000+ square feet
Fulmer:
BioBuffer Solutions Wet Chemistry Labs / Raw Material Warehousing
Under Construction - Completion 2025
Address: 51N 3rd Street, Stroudsburg, PA 18360