This action is being taken as a precautionary measure due to the product being re-packaged in the US using a filler material that (removes or blocks) less moisture than what is approved in the application, the FDA enforcement report said. The Ahmedabad-based pharmaceutical major had launched its generic olanzapine orally-disintegrating tablets in the US in 2011 after FDA approval. Referring to a particular lot (BS392004A, expiry 9/2014) of the drug, the report said that this was a firm initiated voluntary recall.
In June, the UK drugs regulator MHRA had asked Wockhardt to recall 16 medicines from pharmacies and wholesalers after it found deficiencies in manufacturing procedures at the companys Waluj plant. Earlier, the FDA had also imposed an import alert on the same plant. In May, Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, had also made voluntary recall of multiple lots of three of its drugs from the US market due to odd smell, according to USFDA. Last November, the FDA asked Dr Reddys Laboratories to recall a batch of anti-psychotic drug quetiapine fumarate tablets of 25 mg, which failed dissolution test requirements.
Torrents Olanzapine is a generic version of Elli Lillys blockbuster drug Zyprexa, which had $3.2-billion US sales as on September 2011. The innovator drug went off-patent in October 2011. Analysts said the market size for the generic version for the drug was currently $360 million.
Torrent produced the specific batch of Olanzapine at its Indrad facility in Gujarat for US-based Prasco Laboratories, the enforcement report said. Torrent has a significant presence in the gastrointestinal, anti-infective, anti-diabetics and pain management segments, according to its website. Dr Reddys Laboratories, Sun Pharmaceuticals and Jubilant Lifesciences are other Indian pharma players who sell Olanzapine tablets in the US market. Torrent Pharma reported a 44% rise in its net profit and a 27% increase in revenues in Q1FY14, saying its US business grew by 43% y-o-y. Shares of the company closed 3% down at Rs 420.8 on the BSE.