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European Union (EU) GMP Certificate

After the EU inspection by the French Health Authority, ANSM (Agence Nationale de Securité du Médicament) on 09-12 April 2013, we received our EU GMP Certificate with the cover letter dated July 30th, 2014 from the aforementioned institution. In 2018 via document-based audit, the validity of the certificate has been extended until April 12th, 2019. Recently, an inspection has taken place on 08-11 January 2019 for the re-extension of the EU GMP Certificate for another 3 years, until January 2022. This certification is a concrete indicator of our experience and quality and constitutes an important milestone in the realization of our export-oriented production goals. We are proud and glad to share this achievement with our employees and partners.

At the same time, in addition to our existing EU-GMP certification for our Solid Manufacturing unit, we would like to announce that as a result of the Croatian Health Authority's EU (European Union) audit of our Oral Cephalosporin unit during 08-10 October 2014, we also earned the right to receive EU-GMP certification for these products. After the re-inspection by the Croatian Health Authority between 16.10.2017-19.10.2017, our EU-GMP certification was renewed.

In addition to this, after the inspections by the Belarusian Health Authority between 27.04.2015-29.04.2015, our GMP compliance has been registered for ”Injectable  Cephalosporin" and ”Sterile Liquid” forms.

Also, after the inspection by the Ukrainian Health Authority between 01.06.2015 - 05.06.2015, we received our GMP Certificate from Ukraine for ”Sterile Cephalosporin" and ”Sterile Liquid” forms. The Ukrainian Health Authority has sent us the updated certificate on 19.12.2018 and our Ukrainian GMP Certificate has been renewed.

 
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  Zolaks Bilişim