Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
SOFIE is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:2012
Employees:1,091
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
SOFIE Co. dba SOFIE
8285 El Rio Suite 160, Houston, Texas, 77054
Site Capabilities
1 capabilityPOSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
Regulatory Approvals
Drug Approval 00ERWO
FDA · #APR-JU0H7UFX · 2019-08-01
Drug Approval OXQPS2
EMA · #APR-0MWR9E9I · 2020-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-0X85A0Q6
Issued: 2020-12-22
Expires: 2025-10-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-9A2B69CK
Issued: 2020-02-17
Expires: 2025-03-11
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-SFJ2G8D5
Issued: 2020-03-04
Expires: 2025-05-25
Health Canada GMP
Health Canada
Cert #: CERT-06WEM7BL
Issued: 2020-01-05
Expires: 2025-01-09
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Key facts about SOFIE
- SOFIE is headquartered in the United States.
- SOFIE was founded in 2012.
- SOFIE has 1,091 employees.
- SOFIE has one manufacturing site listed on CDMO Hub, in Houston, United States.
- SOFIE's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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