Indian drugmaker Aurobindo announced it was looking into spinning-off its injectable business as a wholly owned subsidiary, in a filing to the Bombay Stock Exchange last Saturday.
Aurobindo spokesperson T Roy Choudhury confirmed to in-Pharmatechnologist.com that a sub-committee of independent directors is to make a presentation in the next couple of months to assess the separation of the injectable business.
“All our injectable units will be shifted under one umbrella to have a much bigger focus and manage the business a lot better,” Choudhury said.
This includes injectable units run by Aurobindo in the Andhra Pradesh region of India – including its new Unit IV liquid injectable plant - and its subsidiary Auronext, located in the Haryana region.
The Board also approved plans to acquire a 60% share of Celon Laboratories for INR 156m ($2.5m). Celon is constructing a greenfield facility which will manufacture injectables for hormonal and oncology products and Aurobindo has committed a further INR 323m over the next 12 months to complete the plant.
A second acquisition - detailed in Aurobindo’s filing – is a 57% stake in Silicon Life Sciences Private. According to Choudhury the firm manufactures non-sterile APIs (active pharmaceutical ingredients) and the purchase will “act as a feeder,” supplying APIs for Aurobindo’s new injectables business.
Injectable Quality Assurance
News of an Indian facility receiving an FDA 483 or Warning Letter is becoming a staple sight on our website – Strides Arcolab and Fresenius Kabi have both made headlines in recent weeks – and Aurobindo too has been subject to problems with the FDA (US Food and Drug Administration) in the past.
The Chitkul Village cephalosporin facility – known as Unit VI - was subject to a warning letter in 2011, citing concerns over potential microbiological contamination, which led to an import ban that has only recently been lifted.
“We put in a lot of effort in auctioning the observations made by the inspectors in order to make the facility compliant,” said Choudhury.
"We now have a very strong focus on safety,” he continued, adding as part of the restructure all its facilities - including the new Celon plant - will be aligned to the same standard. “We have learned our lessons the hard way.”
The firm reported Q1 2014 operating income of INR 17.2bn, up 41% on the same quarter last year with a net profit of INR 186m, compared to a loss of INR 1.29bn.