Manufacturing & Lab Equipment
Company Overview
About
Linhardt GmbH + Co. KG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1991
Employees:2,207
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval M8NU8U
Health Canada · #APR-1EBX1QLT · 2022-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-7CA448C7
Issued: 2020-01-07
Expires: 2025-03-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-JCC9FFXP
Issued: 2020-06-01
Expires: 2025-05-08
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-96WPMMKC
Issued: 2020-11-03
Expires: 2025-05-12
Health Canada GMP
Health Canada
Cert #: CERT-OM6BZ8GI
Issued: 2020-07-26
Expires: 2025-02-26
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Key facts about Linhardt GmbH + Co. KG
- Linhardt GmbH + Co. KG is headquartered in Germany.
- Linhardt GmbH + Co. KG was founded in 1991.
- Linhardt GmbH + Co. KG has 2,207 employees.
- Linhardt GmbH + Co. KG's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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