Egis Pharmaceuticals PLC
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Egis Pharmaceuticals PLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Hungary
Founded:2012
Employees:2,378
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
2 sites worldwide
EGIS Pharmaceuticals PLC
Kereszturi út 30-38, Budapest, 1106
Site Capabilities
4 capabilitiesANALYSIS
API MANUFACTURE
PACK
REPACK
Egis Pharmaceuticals PLC
Bokenyfoldi Ut 118-120, Budapest Xvii
International Regulatory
EU GMP Certificates
33
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval OIBW43
EMA · #APR-H93Y814V · 2021-11-01
Drug Approval INBYHR
PMDA · #APR-G3XLZ8MZ · 2021-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-T9Q8923D
Issued: 2020-02-07
Expires: 2025-06-16
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-I3DKQAQ7
Issued: 2020-09-21
Expires: 2025-03-06
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-ONC79O84
Issued: 2020-01-21
Expires: 2025-06-07
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Key facts about Egis Pharmaceuticals PLC
- Egis Pharmaceuticals PLC is headquartered in Hungary.
- Egis Pharmaceuticals PLC was founded in 2012.
- Egis Pharmaceuticals PLC has 2,378 employees.
- Egis Pharmaceuticals PLC has 2 manufacturing sites listed on CDMO Hub, in Budapest, Hungary and Budapest Xvii, Hungary.
- Egis Pharmaceuticals PLC's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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