Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Menarini Biotech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Italy
Founded:1998
Employees:1,294
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval D4OOL3
EMA · #APR-HAGGYCF3 · 2020-01-01
Drug Approval ML86I6
Health Canada · #APR-TODCKWWI · 2022-02-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-HP2KB3T1
Issued: 2020-01-28
Expires: 2025-04-04
WHO GMP
World Health Organization
Cert #: CERT-U1B0ROXR
Issued: 2020-10-03
Expires: 2025-01-03
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Key facts about Menarini Biotech
- Menarini Biotech is headquartered in Italy.
- Menarini Biotech was founded in 1998.
- Menarini Biotech has 1,294 employees.
- Menarini Biotech's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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