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
Registered Capital:
Registered Address:
Company Type: Production
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