Drug Product
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
Serán BioScience is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2001
Employees:1,977
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
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval 43BMMV
Health Canada · #APR-R2646QYU · 2022-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-1MPN3A34
Issued: 2020-06-14
Expires: 2025-10-09
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-MSBWM2BQ
Issued: 2020-11-15
Expires: 2025-07-08
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-RR9RG9YU
Issued: 2020-01-04
Expires: 2025-08-03
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Key facts about Serán BioScience
- Serán BioScience is headquartered in the United States.
- Serán BioScience was founded in 2001.
- Serán BioScience has 1,977 employees.
- Serán BioScience's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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