12:45 12.08.2014

Arterium Corporation asking Health Ministry to accelerate registration of haemostatic drug

2 min read
Arterium Corporation asking Health Ministry to accelerate registration of haemostatic drug

Arterium Pharmaceutical Corporation (Kyiv) has sent an official letter to Health Minister Oleh Musiy with a request to accelerate the state registration of Tramix haemostatic drug, which could be used in the counterterrorist operation zone when taking care of wounded people.

The corporation told Interfax-Ukraine that Galychpharm, part of the corporation, submitted the application for the registration of the drug in June 2014. The company started preparing for the registration of the medicine in 2011.

"Galychpharm is ready to produce the medicine under the Tramix trade name (with active ingredient tranexamic acid) under the GMP standard, and the price of the medicine will be cheaper than foreign analogs," the corporation said.

The corporation said that Tramix could be used for various types of bleeding and during operations. There is information on the efficiency of tranexamic acid during trauma bleedings. The medicine is very important one for taking medical care of injured people.

"The average term of the registration of medicines in Ukraine is around nine months. Taking into account the acute need in this medicine on the market, Arterium asked the authorized agencies to consider various mechanisms for accelerating the registration procedure for the said medicine," reads the letter of the corporation.

The corporation told Interfax-Ukraine that Tramix is generic injectable medicine, and clinic tests are not foreseen.

"Injectable water solutions have 100% bioavailability with the intravenous introduction and are registered on the basis of proofs of pharmaceutical equivalence to the reference drug. Cyclokapron, 10% solution made by Pfizer was selected as reference medicine for designing of Tramix," Arterium said.

The corporation said that the production line has been already prepared.

Arterium Pharmaceutical Corporation was created in March 2005 along with two pharmaceutical companies – Ukraine's largest manufacturer of antibiotics JSC Kyivmedpreparat, and leader in the production of plant-based drugs JSC Galychpharm.

One of the key owners of the corporation is Finance and Credit financial group (Kyiv) controlled by businessman Kostiantyn Zhevaho.

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