Exela Pharma Sciences
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Exela Pharma Sciences is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2002
Employees:1,026
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Exela Pharma Sciences, LLC.
1245 Blowing Rock Blvd. 1325 William White Place 320 Cooperative Way 2101 Morganton Blvd 1201 Exela Way 1170 West Ave NW, Lenoir, North Carolina, 28645
Site Capabilities
6 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
STERILIZE
Regulatory Approvals
Drug Approval NS8Q7G
EMA · #APR-HJ9K34L3 · 2018-05-01
Drug Approval HN7KU9
PMDA · #APR-VC0R2NVQ · 2018-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-P6Q8P5MO
Issued: 2020-05-05
Expires: 2025-08-16
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-E111DHOM
Issued: 2020-08-28
Expires: 2025-12-03
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-0WKAE3LH
Issued: 2020-04-14
Expires: 2025-08-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-XGO9OH3R
Issued: 2020-08-06
Expires: 2025-08-11
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Key facts about Exela Pharma Sciences
- Exela Pharma Sciences is headquartered in the United States.
- Exela Pharma Sciences was founded in 2002.
- Exela Pharma Sciences has 1,026 employees.
- Exela Pharma Sciences has one manufacturing site listed on CDMO Hub, in Lenoir, United States.
- Exela Pharma Sciences's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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