New Delhi: Glenmark Pharma on Tuesday said the UK drug regulator MHRA has granted final approval to Glenmark Pharmaceuticals Europe for anti-malarial medication ‘Maloff Protect’ as a pharmacy license in the United Kingdom.
Under this approval, patients will be able to purchase Maloff Protect over the counter, without a prescription.
“Glenmark Pharmaceuticals Europe has been granted final approval by the MHRA (Medicines and Healthcare products Regulatory Agency) for Maloff Protect, anti-malarial medication, as a pharmacy license in the United Kingdom,” Glenmark said in a BSE filing.
It further said: “Maloff Protect contains atovaquone and proguanil hydrochloride, and has been available only as a prescription medicine in the UK”.
Maloff Protect will be used in the prevention of malaria in adults travelling to areas where malaria is prevalent.
Glenmark Pharmaceuticals Executive Vice President and Business Head Europe Achin Gupta said: “This is our first major OTC (over the counter) launch in the UK…The launch also marks our entry into the OTC segment primarily through the pharmacy chains. We will continue exploring this route to grow the business”.
Glenmark’s current portfolio consists of over 100 SKUs (stock keeping units) authorised for distribution in the UK, both in-licensed as well as Glenmark’s own products.
The company added that in addition to this approval, Glenmark UK continues to identify and explore both internal as well as external development partnerships to supplement and accelerate the growth of its existing opportunities and future portfolio.