Glenmark receives approval for asthma drug in Russia

Glenmark Pharmaceuticals Limited has received approval for Salmecort (salmeterol & fluticasone) MDI inhaler, from the Ministry of Health (MoH), Russia. The combination preparation contains salmeterol xinafoate and fluticasone propionate, used in the management of asthma and chronic obstructive pulmonary disease (COPD).
 
The approval marks Glenmark’s entry into the respiratory inhaler market in Russia. According to IMS, the total inhaler market in Russia is estimated to be around $ 283 million, out of which the total MDI market is valued at around $ 107 million. Salmecort is expected to be available in the Russian market in Q2 FY 2015-16.
 
“We want to be a significant player in the respiratory space in emerging markets and hence the generic Seretide approval (Salmecort) in Russia, one of the key countries for the company, is an important development for the organisation. The R&D in vitro equivalence for generic Seretide; as well as the chemistry manufacturing and control (CMC) development were extremely challenging and hence it's a great testimony of our cutting edge R&D capabilities,” said Glenn Saldanha, Chairman and MD, Glenmark.
 
In addition to generic Seretide, Glenmark has also received a couple of other key product approvals such as Oflomil nail lacquer, which is the first generic of Loceryl in the Russian market and Sertamycol (sertaconazole) cream in FY 2014-15. The company also launched Kerawort (topical imiquimod, generic of Aldara) in the Russian market in FY 2014-15.
 
Glenmark has already launched generic Seretide in a host of emerging markets like Mexico and Philippines.