Bioiberica whises to inform its customers that its heparin sodium is fully compliant with the new requirements established by the Heparin Sodium USP monograph revision that is effective in USP 37 NF32, on May 1st, 2014.
Bioiberica just opened a new production site of Heparin derivatives within the expansion plan of its Science portfolio.
As every year Bioiberica will attend the CPHI Fair.
Bioiberica participated in two studies to establish the standard ranges of activity of Anti-factor Xa and anti-IIa of sodium heparin organized by EDQM, which will be included in the new revision of the monograph of the European Pharmacopoeia.
The US Authorities inspected the facilities related to the production of heparin in the plants of Palafolls and Probisa.
They focused on ensuring that our traceability system meets the standards currently required by the FDA, which apply to the documentary as well as to the production levels (from the slaughterhouses, to the control of our satellite plants until the final API).