Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Microsize, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United States
Founded:1994
Employees:653
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Powdersize, LLC
20 Pacific Drive, Quakertown, Pennsylvania, 18951
Site Capabilities
1 capabilityPARTICLE SIZE REDUCTION
Regulatory Approvals
Drug Approval 90SHLR
PMDA · #APR-VV1EA8HR · 2021-12-01
Drug Approval RFZ0QN
Health Canada · #APR-41XPD5PY · 2020-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SKUK5LA8
Issued: 2020-03-14
Expires: 2025-08-18
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-IZMK08W1
Issued: 2020-12-17
Expires: 2025-12-26
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Key facts about Microsize, LLC
- Microsize, LLC is headquartered in the United States.
- Microsize, LLC was founded in 1994.
- Microsize, LLC has 653 employees.
- Microsize, LLC has one manufacturing site listed on CDMO Hub, in Quakertown, United States.
- Microsize, LLC's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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