Glenmark Pharmaceuticals Europe (Glenmark) has secured final approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Maloff Protect, its range of atovaquone / proguanil film-coated tablets.
With this approval, Glenmark receives the pharmacy licence in the UK to commercialise Maloff Protect, as an over the counter (OTC) anti-malarial medication.
In addition, adult patients can now purchase Maloff Protect without a prescription.
Containing atovaquone and proguanil hydrochloride, Maloff Protect is said to prevent malaria in adults, especially when they are travelling to disease-affected areas.
Glenmark Pharmaceuticals executive vice-president and Europe business head Achin Gupta said: “The launch of Maloff Protect as an OTC product is a significant development for the UK and our entire European business.
“This is our first major OTC launch in the UK. We are glad that the MHRA, UK has granted us the pharmacy license and thus making the product accessible to millions of citizens who visit countries where Malaria is prevalent.
“The launch also marks our entry into the OTC segment primarily through the pharmacy chains.”
Glenmark currently has more than hundred stock keeping units (SKUs), which are authorised to distribute in-licensed and the company’s own-brand products in the UK.
Glenmark UK aims to continue exploring development partnerships to improve its portfolio and facilitate its growth opportunities in the UK.
Headquartered in Mumbai, Glenmark has 17 manufacturing facilities and six R&D centres.