Alfasigma (Morpho CDMO)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Alfasigma (Morpho CDMO) 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:2007
Employees:2,935
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Europe
Manufacturing Facilities
3 sites worldwide
ALFASIGMA SPA
Via Pontina Km 30, 400, Pomezia, Rome, 00071
Site Capabilities
1 capabilityMANUFACTURE
ALFASIGMA SPA
VIA ENRICO FERMI 1, ALANNO, PE, 65020
Site Capabilities
1 capabilityMANUFACTURE
Biosint S.p.A
Via del Murillo 16, Sermoneta, Latina, 04013
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
9
WHO Prequalified Products
2
Regulatory Bodies
EMA/EudraGMDP
WHO
EMA
Regulatory Approvals
Drug Approval 6TZM4T
Health Canada · #APR-Q8VX9LQB · 2020-11-01
Drug Approval YFV63M
FDA · #APR-KNDIB4KC · 2018-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-BFURUK1Y
Issued: 2020-11-01
Expires: 2025-11-05
WHO GMP
World Health Organization
Cert #: CERT-MLBZM6AH
Issued: 2020-04-17
Expires: 2025-04-10
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Key facts about Alfasigma (Morpho CDMO)
- Alfasigma (Morpho CDMO) is headquartered in Italy.
- Alfasigma (Morpho CDMO) was founded in 2007.
- Alfasigma (Morpho CDMO) has 2,935 employees.
- Alfasigma (Morpho CDMO) has 3 manufacturing sites listed on CDMO Hub, in Pomezia, Italy, ALANNO, Italy and Sermoneta, Italy.
- Alfasigma (Morpho CDMO)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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