Their Latvian Pharmaceutical Company Grindeks Passes Inspection by FDA.
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Kirovs and Anna Lipmans
/By Clive Minchom /
Latvian pharmaceuticals manufacturer Grindeks announced on Friday that it had successfully passed inspection by the U.S. Food and Drug Administration. The newly-issued certification paves the way for Grindeks to cooperate with U.S. partners in developing its business activities on the American market, and also allows Grindeks to start exporting its manufactured Xylazine, Xylazine Hydrochloride and Droperidol to the U.S., as well as continue to supply Oxytocine and Detomidine to its American partners.
The inspection was performed by a U.S. Food and Drug Administration expert for 4 days and was already the 3rd inspection taken at the enterprise. The inspector visited Grindeks manufacturing facilities for its active pharmaceutical ingredients – Oxytocine, Xylazine, Xylazine Hydrochloride, Droperidol and Detomidine- and audited its’ Quality control systems.
Grindeks facilities – source company web site
Grindeks Chairman of the Board Juris Bundulis was very pleased indeed to say: “This successful achievement gives Grindeks new development opportunities and strengthens its position on the global pharmaceutical market, as the U.S. Food and Drug Administration approval is a convincing argument to gain the trust of every client. We are proud of our achievements in manufacturing and quality control and are looking forward to new export opportunities.”
Total Grindeks active pharmaceutical ingredients revenues were over US$24 million in 2012, representing nearly 16% of total company revenues, with a U.S. export volume presently of just US$1 million. Grindeks’ manufactured Oxytocine represented a 30% world market share, and Droperidol a 92% world market share, for these specialized products.
Grindeks headquarters – source company web site
Grindeks is the leading pharmaceutical company in the Baltic states. Its’ main fields of endeavour are in the research, development, manufacturing and sales of proprietary products Mildronate® and Ftorafur®, of more than 100 effective and safe generics and of 24 forms of active pharmaceutical ingredients. Grindeks specializes in the heart and cardiovascular, CNS and anti-cancer medication therapeutic groups. Mildronate is used for the treatment of angina and myocardial infarction by inhibiting the carnitine biosynthesis pathway via the inhibition of gamma-butyrobetaine dioxygenase.
The Grindeks Group consists of four subsidiary companies in Latvia, Estonia and Russia, and it has sales offices in 11 countries. Grindeks’ Products are exported to 55 countries and exports comprises 95% of the total sales of the company. Its primary markets presently are the Baltic States, Russia and other CIS countries, Germany, the Netherlands, Japan and the United States.
Grindeks shares are listed on the Official List of NASDAQ OMX Riga – formerly simply called the Riga Stock Exchange. However as the company’s shares are closely held these tend to trade only “by appointment”, as the expression puts it for shares that are only thinly traded with little float. Latvian businessman Kirovs Lipmans and his wife Anna Lipmans together own just under 50% of the shares. Two private equity funds and the Skandinaviska Enskilda Bank between them own another 30%, leaving just under 20% in the hands of the public.
Grindeks facilities – source company web site
With annual sales in 2012 of US$153 million Grindeks made a net profit of US$17.7 million – for an 11.5% equity return on sales (ROS). With a very strong balance sheet virtually free of intangibles and a year end equity base of over US$138 million, in 2012 the company made nevertheless a 13.7% return on average equity for the year (ROAE).
Operating management is today in the hands of company Chairman Julius Bundulis, who obtained his Doctoral degree in Biological Sciences at the University of Latvia; he earlier graduated from the Faculty of Chemistry also of the University of Latvia.
The company’s principal shareholders Kirovs Lipmans and Anna Lipmans are still very much involved with the company, with Kirov Lipmans acting today as the Chairman of its Council – another term for its Supervisory Board- and his wife Anna, a Neurologist, acting as Deputy Chairman of its Council. He puts the company’s strategic goal very well in his latest address to shareholders:
“Being a leading Baltic pharmaceutical company, Grindeks is step by step approaching its goal to become a significant enterprise on the European market. The company’s financial results for the year 2012 have reaffirmed its ambitions and brought Grindeks closer to its objectives.
Our short-term and long-term goals are linked to our core value: our patients’ health. Our main competitive advantage is an ability to conduct the entire production cycle with our own resources: from R&D to selling final dosage forms. The combination of these factors guarantees the highest quality of our medication that includes efficiency, security and hi-tech performance.”
About the Lipmans : Kirovs and Anna
Kirovs Lipmans is a Latvian Jewish businessman who was born in 1940. He graduated from the Leningrad Institute of Railway and Transport Engineering, and also from the Faculty of Economics of the University of Latvia. As well as acting as Chairman of the supervisory Council of Grindeks since 2003 he has been the President of the National Latvian Ice Hockey Federation since 1998. Kirovs Lipmans also serves as a Member of Executive Committee of the Latvian Olympic Committee.
Anna Lipmans was born in 1948. A certified Neurologist she is a member of the Latvian Medical Association, the Latvian Association of Internists, the Latvian Association of Cardiologists and the Latvian Association of Neurologists. She has been a Member of the Supervisory Council of Grindeks since 2008.