South African Enaleni to reopen plant

At the end of June, Enaleni's recently appointed CEO Jerome Smith decided to momentarily halt manufacturing activities as the plant was not yet ready to comply with newly implemented regulations in the country. The company said that the production suspension was currently common practice within the pharmaceutical industry as the South African regulator - the Medicines Control Council (MCC) - is working to ensure the adherence to international benchmark standards as required by the Pharmaceuticals Inspectorate Cooperation Scheme (PIC/S). The new requirement was implemented on 1 July and is slowly changing the dynamics of the local industry. Commenting on the plant closure, Smith said: "We have had our pain; other local manufacturers still have to go through theirs." ​ The firm's decision to close the facility was also aimed at accelerating the R100m (€10m) upgrade of the plant to become of the first PIC/S compliant facilities in the country, the firm said. "While the upgrade work had no causal effect on the disruption to manufacturing, it was becoming difficult to ensure adherence to existing MCC current good manufacturing practice (cGMP) requirements in an old plant with ageing equipment and the MCC were well aware of the problems,"​ company spokesperson Ros Walsh told Outsourcing-Pharma.com. "Hence Mr Smith's decision to temporarily suspend manufacturing so as to expedite the upgrade." ​ She said that the closure did result in some disruption to some clients however this was limited during July due to existing stocks on hand. "Costs of lost revenues have not yet been finalised for August, however it is anticipated that production on these contract lines will recommence in the next week to ten days, negating any lost revenues for September,"​ explained Walsh. An initial area has been upgraded and the MCC have completed their inspection, added Walsh. "Once we are assured they are satisfied with the new areas, production will get underway."​ The site improvement, which kicked off in March and is expected to be completed in June next year, will increase capacity four-fold and the new facility will also boast a new analytical laboratory and all new primary processing equipment, the company said earlier this year. "Adherence to PIC/S will make Enaleni's manufacturing standards comparable with those of the world's top pharmaceuticals companies,"​ said Enaleni former chief executive Trevor Edwards back in February "This will give Enaleni's products greater international recognition, ensuring export-quality standards." ​ However the whole episode took its toll on the company's bottom line as Enaleni reported a R2.4m operating loss in the first half of the year, mainly due to the plant closure. In addition to its own portfolio of brands which includes FirstPharm Pharmaceuticals, Bioharmony, Muscle Science, Hercules and Caivil, Enaleni also currently manufactures on behalf of several pharmaceutical companies, such as Reckitt Benckiser, Pharma Dynamics and Merck Generics. In the longer term, the company intends to manufacture some of the Cipla Medpro products, a company it acquired in 2005, at the new facility. Meanwhile, the company has also spent the last couple of months reshuffling its management team. The firm appointed Cipla Medpro CEO Jerome Smith as the incoming CEO in June and Trevor Edwards announced his retirement with effect from 17 August. The company CFO Andrew Hall resigned from the board with effect from 17 August as well while the appointment of a replacement for Hall "is well progressed and will be announced in due course,"​ the company said recently. Furthermore Chris Aucamp was appointed as commercial director, starting from 17 August, after being the financial director of Cipla Medpro for 11 years. Aucamp will also fulfil the duties of Group CFO in the interim until a replacement for found.