Hitech Health
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Regulatory, Tech Transfer & Support Services
Company Overview
About
Hitech Health is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Ireland
Founded:1996
Employees:2,086
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
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval B73TLP
FDA · #APR-E3CCFTUP · 2019-09-01
Drug Approval H4X69O
FDA · #APR-BC63OCD9 · 2018-03-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-CIB0B9C4
Issued: 2020-11-11
Expires: 2025-02-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ZDVABJ0G
Issued: 2020-02-21
Expires: 2025-06-02
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-FGKEPFER
Issued: 2020-02-06
Expires: 2025-01-14
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-5MLDMRSR
Issued: 2020-01-27
Expires: 2025-03-06
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Key facts about Hitech Health
- Hitech Health is headquartered in Ireland.
- Hitech Health was founded in 1996.
- Hitech Health has 2,086 employees.
- Hitech Health's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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