Company 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.

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA

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

Comprehensive Quality and Regulatory Program

• FDA Registered and Inspected

• Document Support - DMF Submissions

• FDA & ICH Q7 Guidance for Drug Substances

• 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

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

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.

For more information, please visit: https://www.biospectra.us/technical/manufacturing-capabilities