Rus Eng
Main / Company's news / "GEROPHARM" Group has successfully passed the Ukrainian GMP audit

"GEROPHARM" Group has successfully passed the Ukrainian GMP audit

18 April 2014

GEROPHARM Group of Companies is pleased to announce to receive a certificate of compliance with good manufacturing practice (GMP certificate)

Organization, keeping up to the date and constant improvement of the pharmaceutical quality system is utmost priority for GEROPHARM Group of Companies, and passing a foreign GMP audit is one more significant confirmation of a stable and guaranteed production quality of company’s pharmaceutical products.

This certificate is not the first one for the Group of Companies. “GEROPHARM-Bio”, JSC, which is part of GEROPHARM, Group of Companies, is the first Russian full-cycle plant manufacturing genetically engineered human insulin: from the substance synthesis to the finished dosage form. It is a compound manufacturing complex where sterile medicine is being produced and the critical feature is to maintain aseptic conditions. The plant was opened in October 2013. Since then the company has obtained a license confirming that its production, substances and finished drugs comply with the requirements on a permanent basis. Moreover, the company has passed a certifying audit with the purpose of confirming compliance of the Quality Management System to the requirements of the international ISO 9001:2008 standard and the Russian ISO 9001-2011 GOST.

“We have come to the pharmaceutical market to stay. Moreover, we target not only the Russian market, but international one as well”, says General Director of GEROFARM, Group of Companies Petr Rodionov. “The pharmaceutical market has become a global market a long time ago, and by putting effort into development of new pharmaceuticals and their production we do not limit ourselves with Russia. That is why from the very beginning we had been planning out our new production in accordance with the most relevant GMP requirements long before they became obligatory for Russia”.

GEROFARM, Group of Companies is one of the leading Russian pharmaceutical manufacturers and is in Top-20 of the local manufacturers. Among achievements of the Company: launch of a new production facility, development of projects with foreign partners, development of new drugs, top ratings in prestigious Russian and international surveys. All this is a testimony to successful innovative development of the Russian pharmaceutical industry which helps improve its reputation as a modern, efficient and strong industry.

You are a health care professional?

Go up