KUALA LUMPUR (Sept 6): Apex Healthcare Bhd's wholly-owned unit Xepa-Soul Pattinson (Malaysia) Sdn Bhd has been awarded a certificate of GMP compliance of a manufacturer by a representative of the European Medicines Agency (EMA).
In a filing with Bursa Malaysia today, Apex Healthcare said the certificate — awarded by National Institute of Pharmacy and Nutrition Hungary on Sept 1 — was for Xepa's manufacturing site in Melaka.
Xepa is a manufacturer of off-patent pharmaceuticals including tablets, capsules, oral liquids, creams, ointments and sterile eye drops.
Apex Healthcare said it has pursued EMA's certification to capitalise on opportunities to enter European and other developed markets.
"The EU GMP certificate attests that Xepa is in compliance with the principles and guidelines of good manufacturing practice as laid down in Directive 2003/94/EC of the European Commission," said Apex Healthcare.
"The EU GMP certificate enables Xepa to pursue contract manufacturing opportunities in the European market.
"It further opens new options for Xepa to register Xepa branded generic pharmaceuticals for marketing and sales into member countries of the EU, while strengthening the standing of Xepa as a manufacturer of choice in its existing markets," it added.
Apex Healthcare shares were untraded today. The stock last closed at RM4.71 on Aug 30, giving it a market capitalisation of RM551.76 million.