Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Aspen API is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Netherlands
Founded:2010
Employees:1,683
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
OEB 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval 31YVE2
PMDA · #APR-VXY6M370 · 2021-08-01
Drug Approval YYJONL
Health Canada · #APR-05OTXD6B · 2019-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ELBTSWNX
Issued: 2020-02-25
Expires: 2025-08-06
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ANJ0TLQF
Issued: 2020-06-28
Expires: 2025-08-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-B3Q4QRKD
Issued: 2020-01-02
Expires: 2025-07-22
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Key facts about Aspen API
- Aspen API is headquartered in the Netherlands.
- Aspen API was founded in 2010.
- Aspen API has 1,683 employees.
- Aspen API's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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