Polpharma API
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Drug Product
Company Overview
About
Polpharma API is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Neurology
Quick Facts
HQ:Poland
Founded:1999
Employees:2,369
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval U77AZR
EMA · #APR-E1OFBSZI · 2018-05-01
Drug Approval 0787GV
PMDA · #APR-O0XKJCSD · 2018-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-W5BYBESW
Issued: 2020-03-28
Expires: 2025-08-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-398VDT55
Issued: 2020-02-01
Expires: 2025-10-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-PQI51MDM
Issued: 2020-01-10
Expires: 2025-07-07
Health Canada GMP
Health Canada
Cert #: CERT-LM61EGJ5
Issued: 2020-03-09
Expires: 2025-01-15
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Key facts about Polpharma API
- Polpharma API is headquartered in Poland.
- Polpharma API was founded in 1999.
- Polpharma API has 2,369 employees.
- Polpharma API's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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