Corporate Profile

BioSpectra^TM 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

GMP Product Categories

Active Substances
GMP Custom Products
Excipients and Key Ingredients
GMP Process Chemicals and Solutions
Bulk, GMP Biological Buffers & Denaturants

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
Complete Testing of all Raw Material and Finished Products

Custom GMP Products

Purification of Key Ingredients
Full GMP Product Development
Small Molecule Custom Synthesis
API Development & Manufacturing
GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program

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

Corporate Values & Commitments

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

Facilities: 343,000+sq. ft. – 52+Acres – 5 Campuses in PA
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