Drug Product
Company Overview
About
Satatuote Oy is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Finland
Founded:2013
Employees:1,602
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval 33L0KE
EMA · #APR-PEQTW9E5 · 2018-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
WHO GMP
World Health Organization
Cert #: CERT-IOU0STDJ
Issued: 2020-09-27
Expires: 2025-11-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-O9NDWV8A
Issued: 2020-11-02
Expires: 2025-05-26
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-Y2SYYBC9
Issued: 2020-11-09
Expires: 2025-02-09
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-PXGV6YPT
Issued: 2020-12-20
Expires: 2025-09-15
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Key facts about Satatuote Oy
- Satatuote Oy is headquartered in Finland.
- Satatuote Oy was founded in 2013.
- Satatuote Oy has 1,602 employees.
- Satatuote Oy's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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