Bionativa (bionativa.net)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Bionativa (bionativa.net) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:Italy
Founded:1993
Employees:1,615
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
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval ME9VDI
PMDA · #APR-VZGP4EO3 · 2020-02-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-TXDUB623
Issued: 2020-01-14
Expires: 2025-03-10
WHO GMP
World Health Organization
Cert #: CERT-FJ2B41Q0
Issued: 2020-01-08
Expires: 2025-06-22
Health Canada GMP
Health Canada
Cert #: CERT-UA2QJTFF
Issued: 2020-11-01
Expires: 2025-06-24
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Key facts about Bionativa (bionativa.net)
- Bionativa (bionativa.net) is headquartered in Italy.
- Bionativa (bionativa.net) was founded in 1993.
- Bionativa (bionativa.net) has 1,615 employees.
- Bionativa (bionativa.net)'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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