Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
Nicomac Europe Srl is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Italy
Founded:2002
Employees:2,977
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
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval 72BOVS
FDA · #APR-FKEW9A5K · 2022-09-01
Drug Approval QCNU7E
Health Canada · #APR-7SX3IQZZ · 2022-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-I65CXLQ0
Issued: 2020-08-04
Expires: 2025-01-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-YMARGR3R
Issued: 2020-03-13
Expires: 2025-12-03
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Key facts about Nicomac Europe Srl
- Nicomac Europe Srl is headquartered in Italy.
- Nicomac Europe Srl was founded in 2002.
- Nicomac Europe Srl has 2,977 employees.
- Nicomac Europe Srl's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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