MCC gives Enaleni Pharmaceuticals the green light

Enaleni Pharmaceuticals Limited today confirmed that it had received Medicines Control Council (MCC) approval to proceed with multi-product manufacturing at its Durban-based manufacturing facility.  The facility, currently being renamed Cipla Medpro Manufacturing (Pty) Ltd, which is nearing the final stages of a R195 million upgrade to international PIC/S standards, will commence with the immediate manufacture of some of the group's own products, including AlkaFizz, Gastrolyte and ARVs, including those awarded in the recent government tender.

Jerome Smith, Enaleni Pharmaceuticals CEO, said the MCC's approval of the new upgraded facility was a major milestone and an acknowledgement of the responsible and professional measures implemented by the new management team to transform the previously ageing facility into a state of the art, accredited pharmaceutical plant.

"We are delighted to have received the green light from the MCC. Since the new management team took over in the latter half of last year, we have focused on rectifying the problems at the plant, which entailed addressing flexibility, capability and varying volume capacities which had not been included in the previous upgrade plans. Amongst other modifications, we also introduced effervescent powder manufacture and packing capabilities and are now only one of two facilities in South Africa to offer effervescent manufacturing."

"While we have been in production with Disprin and Dettol on behalf of Reckitt Benkiser SA since late last year in a dedicated upgraded MCC-approved area, we are now ready to utilize the additional new manufacturing areas for both our own lines and for contract manufacturing clients. We are currently negotiating with selected large pharmaceutical companies to manufacture on their behalf. Given the current turmoil within the local manufacturing environment, it is reassuring to know that a sincere commitment to meet the GMP standards of the MCC is recognized and will ensure an internationally accredited facility that will make a significant contribution to local pharmaceutical capabilities. The board remains confident that the upgrade to the factory will prove to be a strategically sound investment," said Smith.