Ranbaxy under regulatory scanner in other countries after US alert, hits exports

Sep 23 2013, 08:31 IST
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Regulators in Australia and Europe, have sought information from FDA about the lapses at Ranbaxy's Mohali facility. Regulators in Australia and Europe, have sought information from FDA about the lapses at Ranbaxy's Mohali facility.
SummaryOther regulators say action will be taken after assessing the US FDA's reply.

units in India.

Ranbaxy clocked over $1 billion sales in the Americas in 2012, while it garnered over $420 million in Europe and over $270 million from Asia and Africa.

Genzyme corp files patent infringement suit against DRL

Hyderabad: Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis, has filed a suit against Dr. Reddy’s Laboratories alleging that the Indian drug maker infringed patents of its blockbuster cancer drug Mozobil on three counts.

Mozobil (plerixafor injection) is a hematopoietic stem cell mobiliser indicated to patients with non-Hodgkin’s lymphoma (blood cancer) and multiple myeloma. In its petition filed in the District Court of Delaware, Genzyme alleged that DRL intimated though a letter that it had submitted an Abbreviated New Drug Application with US FDA seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/ml Plerixafor injection as a generic version of Mobozil drug.

Genzyme sought the court to declare that DRL’s making, using, selling, offering to sell, or importing its Plerixafor ANDA Injection Product by DRL is infringement of one or more claims of the patents.

According to Sanofi’s 2012 annual report, Mozobil contributed euro 96 million to its revenues.

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