Strides Arcolab facility gets the nod from FDA
pharmafile | May 3, 2011 | News story | Manufacturing and Production | Pfizer, distribution issues
Indian pharmaceutical manufacturer Strides Arcolab has been given a green light from the FDA for a facility in Bangalore that’s central to its oncology agreement with Pfizer.
The US regulator’s approval of the facility, which makes a range of cancer drugs including sterile injectables as well as tablets and softgels, will “enable Strides to play a more significant role in the global oncology industry”, the company said.
In January 2010, Strides forged a licensing and supply agreement with Pfizer under which the Indian firm would develop and manufacture up to 40 different generic products to be sold by Pfizer in the US market, focusing on mainly cancer medicines.
In May 2010 that deal was widened to include generic 38 anticancer medicines in Europe, Canada, Australia, New Zealand, Japan and Korea. In January 2011 Pfizer extended its arrangement with Strides once again, this time paying $63 million to acquire another 22 generics – including anti-infectives – from Akorn-Strides, the Indian company’s US joint venture.
Pfizer is looking to diversify its business to help offset the looming US patent expiry of its biggest product, cholesterol-lowerer Lipitor (atorvastatin), later this year. Strides also has a collaboration with GlaxoSmithKline in the area of injectable generic medicines, which was formed in 2008.
The facility is operated by Strides’ subsidiary Onco Therapies, part of its Agila specialty pharmaceuticals division, and is one of five plants the company operates in India. The company recently announced the FDA approval of its sterile non-oncology plant, also in Bangalore.
“We now look forward to scaling up our specialty business through the launch of highly specialised products for the US market”, commented Venkat Iyer, chief executive of Agila.
The Indian drugmaker has already filed for approval of 31 generic cancer drugs made at the facility in the USA, which collectively address a market valued at more than $4 billion. It expects to start selling its first oncology product for the US market in the second half of 2011.
Phil Taylor
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