“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 5.1 million 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.
Grindeks is the leading pharmaceutical company in the Baltic States. Its main business fields are research, development and manufacturing of brand products, generics and APIs. Grindeks concern consists of four subsidiary companies in Latvia, Estonia and Russia as well as ten representative offices. Products of the company are exported to more than 40 countries. Main markets are the Baltic States, Russia and CIS countries, Japan, USA. Grindeks shares are listed in the Official List of “Nasdaq OMX Stock Exchange”.
Founded in 1908, “BIOL” is private and medium-sized argentine company, specialized in the elaboration of biological products. Nowadays “BIOL” produces and commercializes products of its own elaboration and from licences of prestigious foreign companies, being its main goal to contribute to improve the patients’ quality of life by providing efficient and reliable medications. “BIOL” counts on a wide range of products orientated to different medicinal specialties, such as Gynaecology and Obstetrics, Critical Care and Biological Line (Sera and Vaccines).
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* PATH – Program for Appropriate Technology in Health – is an international nonprofit organisation, which in co-operation with different state and private sector partners provides appropriate health technologies and vital strategies, mainly, to developing countries and poor region. More detailed information: http://www.path.org/ and http://www.pphprevention.org/
**According to WHO’s data, postpartum haemorrhage, or excessive bleeding after childbirth, kills an estimated 150,000 women each year