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.