Martindale Pharma, the UK-based international specialty pharmaceutical company, today announced the regulatory approval of its clobazam oral suspension product, Epaclob® in France, Ireland, Germany and Italy and Silocalm® in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP).
Epaclob/Silocalm are based on Tapclob®, the world's first oral liquid suspension version of clobazam to receive regulatory approval, which has been available from Martindale Pharma under the tradename Tapclob since May 2013. Clobazam oral suspension is used principally as an adjunctive therapy for epilepsy with the formulation particularly suitable for children and young adults. Epaclob/Silocalm are approved in two strengths, 5mg/5ml and 10mg/5ml, and will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Commenting on the approval Michael Harris, CEO of Martindale Pharma, said: "Martindale Pharma is committed to developing and providing provide high quality innovative products to our customers and to patients in international markets. We are pleased to have received regulatory approval of our oral liquid formulation of clobazam in an additional seven European countries. Already an established product in the UK, this formulation not only allows for better ease of use, especially for paediatrics, but will allow both prescribers and patients access to a much needed safe and cost-effective licensed oral liquid formulation when required."
Notes to editors
About Martindale Pharma®
Martindale Pharma is a leading UK-based, international specialty pharmaceutical company providing essential medicines to over 50 countries around the world.
Our strategy is to build leading positions in defined business segments where there is a high unmet medical need and a demand for improved product presentations. Our focus is on Opioid Addiction, Emergency Care, Hospital-initiated Medicines, Ophthalmics and Unlicensed Medicines (also called "Specials").
With a strong UK presence and expertise in marketing hospital and specialty medicines, Martindale Pharma is recognised as a strategic partner to the NHS and other healthcare providers, supplying over 100 licensed products, and has a track record of successful new specialty product launches.
The business also includes a rapidly growing international organisation currently centred on three geographical regions: Saudi Arabia and the Gulf Co-Operation Council territory, Australia and South East Asia and Northern Europe (focused on Scandinavia).
Uniquely as an independent pharma company, the business is underpinned by our own modern, efficient UK manufacturing facility which enables us to develop and compete globally to supply high quality, low cost specialty pharmaceuticals in sterile injection and oral liquid formats.
For further information visit our website http://www.martindalepharma.co.uk
Tel: +44 (0) 1628 551934
Mary Clark, Hollie Vile, Alex Protsenko
Tel: +44 (0) 207 862 6390
SOURCE Martindale Pharma