Statement from National Pharmaceutical Industries
In reference to recent news articles and media reports citing circular No 11/2016 issued by the Directorate General of Pharmaceutical Affairs and Drug Control at the Ministry of Health regarding the recall of Omafen tablets wherein there is an impression that aluminium pieces are present in the tablet, National Pharmaceutical Industries (NPI) would like to clarify that there is no aluminum pieces present in the tablet. In isolated cases, a piece of aluminum packing foil was found in a blister cavity. As part of NPI’s commitment to safety and quality, Omafen tablets from specific batches were recalled from the market in close coordination with the Ministry of Health.
NPI prides itself in maintaining the highest quality standards in pharmaceutical production in the GCC. Over the last 15 years, NPI has demonstrated its commitment to comply with rigorous industry standards to manufacture world-class products that today are sold in over 12 countries around the world. Product quality assurance stems from the company’s strict adherence to cGMP regulations, qualification reviews of material vendors, stringent in-process controls and effective change and document control systems. All NPI equipment, facilities and products, in addition to cleaning procedures are completely validated and documented. Self-audits and audits by regulatory bodies on a periodic basis ensure strictc GMP compliance.