Drug Product
Excipients & Specialty Ingredients
Company Overview
About
PROBIOTICAL S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Italy
Founded:2018
Employees:207
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 II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 24C58M
FDA · #APR-EP97HW8W · 2022-07-01
Drug Approval 2MLTKS
EMA · #APR-UUREYX5F · 2020-12-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EVQ4QX36
Issued: 2020-09-20
Expires: 2025-06-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-QXKIE1IF
Issued: 2020-12-04
Expires: 2025-05-25
Health Canada GMP
Health Canada
Cert #: CERT-46NUBKJS
Issued: 2020-12-15
Expires: 2025-11-07
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Key facts about PROBIOTICAL S.p.A.
- PROBIOTICAL S.p.A. is headquartered in Italy.
- PROBIOTICAL S.p.A. was founded in 2018.
- PROBIOTICAL S.p.A. has 207 employees.
- PROBIOTICAL S.p.A.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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