OREANDA-NEWS. On 07 April 2009 was announced, that Grindeks was proposed by the pharmaceutical company “Instituto Biológico Argentino S.A.I.C.” (“BIOL”) for a joint international project "Oxytocin in Unijecttm" conducted by PATH*. Within the scope of the project Grindeks will produce and supply an active pharmaceutical ingredient oxytocin to “BIOL”.

"Oxytocin in Unijecttm" is an innovative non-reusable injection device prefilled with a single dose of oxytocin. "PATH" and "BIOL" have collaborated since 2004 to make oxytocin available in "Uniject" as part of numerous global initiatives to reduce materially the postpartum hemorrhage in women**, in general, in the developing countries. "PATH" developed the "Uniject" device to improve the ease and safety of administration of injectable drugs. "BIOL" in cooperation with "PATH" conducted investigation, development and registration of the final product in "Uniject". At the moment, the product is already registered in Argentina; soon its registration will be launched in other countries of Latin America, later in other world countries.

To continue established cooperation "BIOL" and the "World Health Organisation" ("WHO") invited Grindeks to take part in "WHO"'s work to update its process for qualifying pharmaceutical suppliers. The invitation was based on the international partners' positive references as to high quality of oxytocin produced by Grindeks, which is also proved by registration of the product in such quality standard demanding country as the US as well as Australia, EU and other countries. In the course of the project Grindeks developed the monograph about oxytocin quality, which "WHO" will apply in assessment of the product's quality in future projects.

Andris Jegorovs, Director of Grindeks API Business Unit emphasises: "Invitation to cooperate in these global projects is the highest assessment of our APIs quality and professional accomplishment in the development of monograph. This will ensure an opportunity for Grindeks to become the largest manufacturer of oxytocin substance in the world."

Grindeks is carrying out API business development successfully both on existing and new markets, whereupon the export of APIs in 2008 reached 5.1million lats, which is by 1.2 million lats or 30.8 % more than in 2007. Oxytocin is one of the most demanded Grindeks APIs. Exporting it, Grindeks has gained 35% of the world market. Market position strengthening and footholds gaining in new markets are being advantaged by international certificates proving the quality of oxytocin, such as "Good Manufacturing Practice", "Certificate of Suitability" which is facilitating registration of the product in any and all countries where Europe pharmacopoeia is applicable, as well as "Food and Drug Administration" conclusion affirming conformity with USA quality standards.