July 9 (SeeNews) - The U.S. Food and Drug Administration (FDA) said that it has granted approval to Bulgarian drug maker Huvepharma's Monovet 90 - a generic monensin drug for use in cattle and goats.
The drug serves for the prevention and control of coccidiosis in cattle and goats, as well as for improved feed efficiency in cattle, the FDA said in its approval summary dated July 1.
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The submitted data demonstrate that Monovet 90, when used according to the label, is safe and effective. In addition, residues in food products derived from species treated with Monovet 90 will not represent a public health concern when the product is used according to the label, FDA said.
Earlier this year, the U.S. Department of Agriculture (USDA) said that it intends to grant Huvepharma an exclusive royalty-bearing licence for an experimental African swine fever vaccine.
Huvepharma's manufacturing subsidiary Biovet, has three production sites in Bulgaria and two facilities in the USA. Last week, Biovet said that it will launch this year the construction of a new plant for vaccines at its production base in the town of Razgrad, and will continue the construction of its plant for pharmaceutical products and feed additives in the town of Peshtera.
Last year, Huvepharma acquired French companies Qualian and Laboratoire Meriel, as well as Qualian Portugal Unipessoal and Qualian Italy. The acquisitions include two new factories in France and one in Italy, Huvepharma said at the time.
Huvepharma has representative offices and subsidiaries in Bulgaria, Belgium, Poland, China, Taiwan, Thailand, the USA, Russia, India, Brazil and Turkey.