Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
Tema Sinergie is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Italy
Founded:2013
Employees:1,984
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
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 EZ4PD0
EMA · #APR-ZST7HOIX · 2022-11-01
Drug Approval II8I3R
Health Canada · #APR-OXE0BLZF · 2021-08-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-M22V82MP
Issued: 2020-08-12
Expires: 2025-09-09
Health Canada GMP
Health Canada
Cert #: CERT-X4GDMZH6
Issued: 2020-04-18
Expires: 2025-01-10
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Key facts about Tema Sinergie
- Tema Sinergie is headquartered in Italy.
- Tema Sinergie was founded in 2013.
- Tema Sinergie has 1,984 employees.
- Tema Sinergie's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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