Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Mastelli Srl is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Italy
Founded:1991
Employees:1,518
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
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Europe
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval PVV9LW
FDA · #APR-PEKCNNPI · 2020-06-01
Drug Approval 47GDDR
PMDA · #APR-3H8KDSG8 · 2022-03-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KQ9ZRVSG
Issued: 2020-12-21
Expires: 2025-03-21
WHO GMP
World Health Organization
Cert #: CERT-XZ6ITSGI
Issued: 2020-08-27
Expires: 2025-11-15
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-PE1MUJHR
Issued: 2020-09-04
Expires: 2025-11-08
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Key facts about Mastelli Srl
- Mastelli Srl is headquartered in Italy.
- Mastelli Srl was founded in 1991.
- Mastelli Srl has 1,518 employees.
- Mastelli Srl's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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