GMP Product Categories:

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

Custom GMP Products:

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

Exclusively Manufactured in the USA - APIs / Excipients / Critical GMP Process Chemicals

FDA Registered and Inspected, ICH Q7, IPEC & US GMP Compliant, BioSpectra exclusively manufactures all its products at its state-of-the-art GMP facilities in Bangor and Stroudsburg PA, USA. Products include APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions. In addition, BioSpectra offers a range of contract, and custom GMP manufacturing services. 

BioSpectra operates out of 175,000 square feet of GMP manufacturing and storage facilities. We adhere to the most rigorous quality system while upholding the highest regulatory standards. Our goal is to become a valued partner in your secure supply chain and the solution to any key ingredient issue you may have.

COMPREHENSIVE QUALITY & REGULATORY SYSTEM

• FDA Registered & Inspected
• Full Transparency in Documentation
• Stringent Quality Program & Controls
• Document Support - DFM 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

True US GMP Manufacturing of Premium Pharmaceutical Ingredients

• 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