BioSpectra, Inc.
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Drug Product
Excipients & Specialty Ingredients
Company Overview
About
BioSpectra, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2004
Employees:490
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
2 sites worldwide
BioSpectra Inc.
1474 Rockdale Lane, Stroudsburg, Pennsylvania, 18360
Site Capabilities
2 capabilitiesANALYSIS
MANUFACTURE
BioSpectra Inc.
100 Majestic Way, Bangor, Pennsylvania, 18013
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Regulatory Approvals
Drug Approval PQDK6Z
Health Canada · #APR-J4WJ6JNS · 2021-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-15I2NSXN
Issued: 2020-01-15
Expires: 2025-03-08
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-H5AJRKTJ
Issued: 2020-07-01
Expires: 2025-12-09
Health Canada GMP
Health Canada
Cert #: CERT-POOSWD69
Issued: 2020-10-04
Expires: 2025-06-03
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Key facts about BioSpectra, Inc.
- BioSpectra, Inc. is headquartered in the United States.
- BioSpectra, Inc. was founded in 2004.
- BioSpectra, Inc. has 490 employees.
- BioSpectra, Inc. has 2 manufacturing sites listed on CDMO Hub, in Stroudsburg, United States and Bangor, United States.
- BioSpectra, Inc.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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