Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Hapila GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1994
Employees:1,540
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Hapila GmbH
Otto-schott-str. 9, Gera, 07552
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval E8HGWK
EMA · #APR-RAV1GZ9H · 2018-03-01
Drug Approval O4TN62
PMDA · #APR-KA88X204 · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-VL0IHC8P
Issued: 2020-03-05
Expires: 2025-05-21
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-6P8R9OM9
Issued: 2020-05-04
Expires: 2025-02-20
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8T1YN42T
Issued: 2020-05-14
Expires: 2025-12-06
WHO GMP
World Health Organization
Cert #: CERT-C6F57DPF
Issued: 2020-03-20
Expires: 2025-10-22
Loading CDMO intelligence...
Key facts about Hapila GmbH
- Hapila GmbH is headquartered in Germany.
- Hapila GmbH was founded in 1994.
- Hapila GmbH has 1,540 employees.
- Hapila GmbH has one manufacturing site listed on CDMO Hub, in Gera, Germany.
- Hapila GmbH's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
Find CDMOs like Hapila GmbH
Directory pages this company appears in, each with the full list of matching manufacturers.