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Active Pharmaceutical Ingredients

BioSpectra’s Active Pharmaceutical Ingredients are US manufactured in our FDA Registered facility located in Bangor, Pennsylvania. BioSpectra’s APIs are manufactured in accordance with ICH Q7 guidelines using qualified equipment and utilities,validated processes and a traceable supply chain. An API manufactured at BioSpectra has the following characteristics:

Key Compliance Attributes of BioSpectra’s Grades
Bio Active Grade
ICH Q7 Compliant Manufactured
Bio FUISA Grade
ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic
Yes
Yes
Each Batch 100% Analyzed
Yes
Yes
Management of Change
Yes
Yes
Validated Analytical Methods
Yes
Yes
Compendial Testing
Yes
Yes
Trace Metals Analyzed
Yes
Yes
Two Year Stability
Yes
Yes
BioSpectra Supply Chain Audit Trail
Yes
Yes
Product Origin Statement
Yes
Yes
Customer Quality Audits
Yes
Yes
Customized Additional Specifications
Yes
Yes
Multi-Compendial Testing
Yes
Yes
Enzyme Tested
Yes
Yes
Validated Manufacturing Process
Yes
Yes
US Manufactured at BioSpectra
Yes
Yes
IPEC cGMP Compliant Manufactured
Yes
Yes
Suitable for use as Excipient
Yes
Yes
Microbial / Endotoxin Tested
Yes
Yes
Manufactured in FDA Registered Facility
Yes
Yes
Customized Manufacturing Schedule
Yes
Yes
Custom Regulatory Packet
Yes
Yes
Accelerated Stability
Yes
Yes
Type IV Drug Master File
N/A
N/A
Video Conference access to BioSpectra Sites
Yes
Yes
Complete access to Product Traceability
Yes
Yes
Access to Supply Chain Information
Yes
Yes
ICH Q7 Qualified Utilities
Yes
Yes
ICH Q7 Compliant Manufactured
Yes
Yes
Suitable for use as Active Ingredient
Yes
Yes
Suitable for use in a Sterile Application
No
Yes
Type II Drug Master File
Available
Available
Available indicates an attribute or level of compliance which is granted based on mutual contractual understanding and typically requires special pricing.
N/A
indicates an attribute or level of compliance which does not apply to that particular grade.