RENOLIT Healthcare
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Drug Product
Manufacturing & Lab Equipment
Company Overview
About
RENOLIT Healthcare is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:1994
Employees:345
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval WAC8WB
Health Canada · #APR-AXT9AS3A · 2019-10-01
Drug Approval 3D2MQ3
Health Canada · #APR-15DRG1IX · 2019-01-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-ME3YY48T
Issued: 2020-09-13
Expires: 2025-06-10
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-R7W00EDF
Issued: 2020-08-12
Expires: 2025-06-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4AN04CC8
Issued: 2020-07-08
Expires: 2025-04-26
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-048QOB92
Issued: 2020-11-14
Expires: 2025-08-23
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Key facts about RENOLIT Healthcare
- RENOLIT Healthcare is headquartered in Germany.
- RENOLIT Healthcare was founded in 1994.
- RENOLIT Healthcare has 345 employees.
- RENOLIT Healthcare's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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