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FDA authorizes Bioiberica’s customers to commercialize their heparin After adapting to the new and complex requirements of the USP (United States Pharmacopea), and having successfully passed the FDA (Food and Drug Administration) inspection of our installations, this organization has communicated that Bioibérica is prepared to market their active ingredient Heparin in the USA.
The authorization process started at the end of 2008, when Bioibérica sent their DMF (Drug Master File) to the North American organization.
In March 2009, Bioibérica’s installations in Palafolls (Gerona), and Olérdola (Barcelona) were examined by FDA inspectors, who reported a good result of the analysis.
The inspection, which covered quality systems, equipments and installations, laboratories, materials and fitting-out among others, finished with excellent results. All this confirms that the manufacturing process of heparin is carried out under the principles of Good Manufacturing Practices (GMP).
FDA certified in April 2009 that Bioibérica meets the requirements of the American authorities to supply this market with heparin. This requirement is necessary to commercialize the drug in the USA.
However, in September, USP (United States Pharmacopea), the organization which decides the characteristics that heparin should have, changed the specifications of the active ingredient, for this reason, Bioiberica presented an amendment to its initial DMF to adapt the product to the new requirements of the American Pharmacopea.
The right strategy of Bioiberica has allowed the customers to obtain the final approval in February 2010 to introduce the Bioiberica’s active ingredient in the USA in record time.
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