Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Lomapharm GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:2010
Employees:241
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
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval UT4X1Q
Health Canada · #APR-JMISO8CO · 2022-07-01
Drug Approval LV7ZXW
PMDA · #APR-DG7182RG · 2019-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-2SFEFH5F
Issued: 2020-10-12
Expires: 2025-08-26
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-MZ5V923M
Issued: 2020-08-16
Expires: 2025-12-07
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-91704NOS
Issued: 2020-08-08
Expires: 2025-09-04
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Key facts about Lomapharm GmbH
- Lomapharm GmbH is headquartered in Germany.
- Lomapharm GmbH was founded in 2010.
- Lomapharm GmbH has 241 employees.
- Lomapharm GmbH's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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