When Aurobindo forked over $ 1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S. But it is one that brings a history of quality issues when it comes to manufacturing, as exemplified in the latest thrashing by the FDA.
The agency this week posted a Form 483 for Aurobindo’s plant in Telangana with nearly a dozen observations but one overriding issue, the agency said. The plant’s quality control unit, which should be ensuring products meet the highest standards before shipping to the U.S., doesn’t seem to know what it is doing.
The problems ran a gamut from poorly trained visual inspectors to the company’s indifferent treatment of customer complaints about vials that had black particles in them. The company said the particles “were intrinsic” to manufacturing when FDA inspectors indicated they most likely were from shedding stoppers.
Manufacturing issues have been an ongoing concern of the FDA’s when it comes to Aurobindo. The citation came just weeks after a key sterile injectables plant in Pashamylaram, Hyderabad, was written up in December for the second time in two years. Aurobindo has had similar problems at another sterile manufacturing plant in nearby Bachupally.
The FDA finding comes as the Indian drugmaker has significantly increased its footprint the U.S. generics market with three plants, 750 employees and a portfolio of 300 drugs it acquired in September from Novartis’ Sandoz unit for $ 1 billion. Those included Sandoz’ U.S. dermatology line.
At the time, Aurobindo managing director N. Govindarajan claimed the deal would make his company the second-largest dermatology player in the U.S. generics market and the second-largest generics company by prescriptions. Of course, it is yet to be seen how Aurobindo will fare with the drugs, given that Sandoz tossed them off for having insufficient margins in a very challenged U.S. generics market.
But Aurobindo is not content to be simply a generics player in the U.S. It pulled off a smaller deal in January when it agreed (PDF) to pay up to $ 300 million for seven branded injectable cancer drugs from Irvine, California-based Spectrum Pharmaceuticals, along with what it termed a substantial commercial infrastructure to support them.