Microinnova Engineering GmbH
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Drug Product
Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
Microinnova Engineering GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:Austria
Founded:1993
Employees:1,859
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval Z7ADLH
FDA · #APR-D0DN5DFW · 2021-02-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-U9DMYEWD
Issued: 2020-11-04
Expires: 2025-09-28
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-KPW60O3G
Issued: 2020-08-27
Expires: 2025-03-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-O5MFLI65
Issued: 2020-05-22
Expires: 2025-05-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-0PMTN70D
Issued: 2020-06-17
Expires: 2025-10-22
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Key facts about Microinnova Engineering GmbH
- Microinnova Engineering GmbH is headquartered in Austria.
- Microinnova Engineering GmbH was founded in 1993.
- Microinnova Engineering GmbH has 1,859 employees.
- Microinnova Engineering GmbH's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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