Röchling Medical Neuhaus GmbH & Co. KG
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Drug Product
Manufacturing & Lab Equipment
Company Overview
About
Röchling Medical Neuhaus GmbH & Co. KG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1992
Employees:2,247
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval 5FE0KD
PMDA · #APR-VN83JA3E · 2022-10-01
Drug Approval RYYEU8
Health Canada · #APR-9I4EZAIF · 2020-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-10BGR0HZ
Issued: 2020-12-27
Expires: 2025-03-28
WHO GMP
World Health Organization
Cert #: CERT-VK8ON1GI
Issued: 2020-03-12
Expires: 2025-02-12
Health Canada GMP
Health Canada
Cert #: CERT-TYP2WP1I
Issued: 2020-12-06
Expires: 2025-08-26
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Key facts about Röchling Medical Neuhaus GmbH & Co. KG
- Röchling Medical Neuhaus GmbH & Co. KG is headquartered in Germany.
- Röchling Medical Neuhaus GmbH & Co. KG was founded in 1992.
- Röchling Medical Neuhaus GmbH & Co. KG has 2,247 employees.
- Röchling Medical Neuhaus GmbH & Co. KG's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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