The FDA withdraws the warning letter that kept on the products of Ercros pharmaceutical division

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Madrid, April 11, 2016. - US public agency FDA (Food and Drug Administration) has given its approval to the remedial actions taken by the Ercros division of pharmacy as a response to the inspection carried out at the factory in Aranjuez in December 2014, and it has communicated the withdrawal of the warning letter that was kept on their products.

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The fact that there was a warning letter on pharmaceutical division products has not prevented Ercros to continue marketing in the US and other markets which refer to the US market by its high level of quality required for pharmaceutical products. However, with the withdrawal of the FDA warning, Ercros products meet greater prestige and international projection.

The FDA is the agency of the US government responsible for the regulation of food and drugs marketed in their country. Registration in the entity is required to export any pharmaceutical product to its territory. Its agents periodically inspect export companies to ensure the compliance with all regulations.

Ercros pharmaceutical division has made a significant effort to meet the requirements of the FDA. In addition to considerable financial and personal investment, it has opted for a change in management and prioritise the quality and compliance with standards of Good Manufacturing Practice This trend has also been observed in multiple customers’ and regulatory authorities’ audits.

The activity of the pharmaceuticals division focuses on the production of raw materials and intermediary pharmaceutical products, of the family of antibiotics, cholesterol-lowering, anti-ulcer and anti-fungal products. The pharmaceutical division accounts for 8% of the turnover of the group Ercros and its exports account for 91% of sales. In 2015 its turnover grew by 24.6% reaching EUR 48.83 million.


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