We manufacture our products by following our customers’ and health authorities’ most stringent requirements.
Facilities for the production of APIs undergo rigorous inspections from the U.S. Food and Drug Administration (FDA). Our multipurpose plant passed FDA inspections in 2004, 2009, 2012, 2015, and, most recently, May 2018. This is something we are proud of and that confirms the highest quality standards of Polpharma.
USFDA
EDQM/EMA
Local MOH
SKFDA
ANVISA
PMDA
Inspections & Audits
Polpharma has EU GMP certificates for all production departments and all API products.
Quality & compliance
GMP
FDA
2004/2009/2012/2015/2018
We supply APIs for pharmaceutical companies worldwide.
With a competitive cost of production, superior product quality and environmentally friendly processes API Polpharma is a significant European manufacturer.
As part of our commitment to provide the highest CDMO service, we put the greatest emphasis on:
Documentation in an eCTD format and CEP certificates
Specifications for every stage of production
Qualification and audits of suppliers
Quick response to complaints
System procedures
Compliance with cGMP
On-the-job GMP training
Validation and qualifications of equipment and production processes