Drug Product
Analytical & Bioanalytical Services
Company Overview
About
E-Pharma Trento S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Italy
Founded:1991
Employees:1,516
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval BXZXQR
FDA · #APR-ZOOJ5Q6E · 2021-07-01
Drug Approval T008FV
PMDA · #APR-QJPNZFLZ · 2018-02-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-N8ZQ5W8O
Issued: 2020-10-18
Expires: 2025-01-03
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-IDDS22J1
Issued: 2020-09-08
Expires: 2025-04-17
Health Canada GMP
Health Canada
Cert #: CERT-OV95EVO0
Issued: 2020-06-23
Expires: 2025-06-23
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Key facts about E-Pharma Trento S.p.A.
- E-Pharma Trento S.p.A. is headquartered in Italy.
- E-Pharma Trento S.p.A. was founded in 1991.
- E-Pharma Trento S.p.A. has 1,516 employees.
- E-Pharma Trento S.p.A.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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