Biofarma S.p.A. (Biofarma Group)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Biofarma S.p.A. (Biofarma Group) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:China
Founded:2013
Employees:1,737
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
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
Rio Biofarma Brasil Ltda
Rod JORNALISTA FRANCISCO AGUIRRE PROENCA S/N BLOCO 53, Hortolandia, Sao Paulo, 13186-901
Site Capabilities
1 capabilityMANUFACTURE
BIOFARMA SRL
VIA DELL'ARTIGIANATO 14, SAN PIETRO VIMINARIO, PADOVA, 35020
Site Capabilities
1 capabilityMANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval YQR63Z
Health Canada · #APR-6RYPMM0A · 2019-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-V1ONNUIT
Issued: 2020-11-01
Expires: 2025-12-23
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-R13QEDG1
Issued: 2020-08-25
Expires: 2025-01-17
WHO GMP
World Health Organization
Cert #: CERT-JRJDSZOD
Issued: 2020-02-22
Expires: 2025-12-16
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Key facts about Biofarma S.p.A. (Biofarma Group)
- Biofarma S.p.A. (Biofarma Group) is headquartered in China.
- Biofarma S.p.A. (Biofarma Group) was founded in 2013.
- Biofarma S.p.A. (Biofarma Group) has 1,737 employees.
- Biofarma S.p.A. (Biofarma Group) has 2 manufacturing sites listed on CDMO Hub, in Hortolandia, Brazil and SAN PIETRO VIMINARIO, Italy.
- Biofarma S.p.A. (Biofarma Group)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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