SyntalPharma (Syntal Pharma Sp. z o.o.)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
SyntalPharma (Syntal Pharma Sp. z o.o.) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Poland
Founded:2010
Employees:426
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
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 FYPG8G
EMA · #APR-RAB6TV1H · 2022-03-01
Drug Approval 1XR494
Health Canada · #APR-CSS218SI · 2019-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-6X2EF8VT
Issued: 2020-10-27
Expires: 2025-04-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-IFGEV3XJ
Issued: 2020-02-02
Expires: 2025-07-23
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Key facts about SyntalPharma (Syntal Pharma Sp. z o.o.)
- SyntalPharma (Syntal Pharma Sp. z o.o.) is headquartered in Poland.
- SyntalPharma (Syntal Pharma Sp. z o.o.) was founded in 2010.
- SyntalPharma (Syntal Pharma Sp. z o.o.) has 426 employees.
- SyntalPharma (Syntal Pharma Sp. z o.o.)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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