Petrovax completed the first stage of thrombolitics production localization

Boehringer Ingelheim and NPO Petrovax Pharm have successfully completed the first major stage of their work to transfer the technology for manufacturing Metalyse® (INN: tenecteplase), a medicinal product for the treatment of acute myocardial infarction, in the Russian Federation.

The first commercial lots of localized drug have been already received by medical institutions in Russia and are available for emergency medical care. The commercial lots of tenecteplase were manufactured at the facility of NPO Petrovax Pharm, a strategic partner of Boehringer Ingelheim in Russia and leading Russian developer and manufacturer of innovative medicinal products and vaccines. Thus, the need for the drug will be satisfied completely. The localization will also allow to reduce the logistics cycle and delivery period.

The project includes the transfer of the full manufacturing cycle for Actilyse® (alteplase), a trombolytic well known in the clinical practice and intended for the treatment of acute ischemic stroke and myocardial infarction, to facilities of NPO Petrovax Pharm. By the end of 2017, the first lots of Actilyse® packaged in Russia will be available to patients. From 2019, the drug will be manufactured in Russia under the full technological cycle in the amount that is sufficient for the treatment of the Russian patients with these severe pathologies.

SOURCE: gmpnews.ru
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