Cadila recalls anti-depressant generic batches from US

Drug maker Cadila Healthcare had recently recalled select batches of its anti-depressant tablet medicine, venlafaxine hydrochloride, from the US market, a source said.

“The drug was recalled in March after some pharmacists complained of an excessive amount of broken and chipped tablets in some batches,” the source told Business Standard.

An e-mail query to Cadila got no response.

The US market for venlafaxine hydrochloride tablets, the generic version of Pfizer’s Effexor, is estimated at a little over $2 billion annually. The financial impact on Cadila due to the recall could not be ascertained.

The source said batches of the recalled drug were being manufactured at Cadila’s Ahmedabad facility. Distribution was through its US arm, Zydus Pharmaceuticals USA Inc.

“It is classified as a class-II recall by the US FDA (Food and Drug Administration),” the source said.

According to the FDA’s classifications, a class-II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

Today, Cadila’s shares ended at Rs 751.50 on the Bombay Stock Exchange, down about one per cent from yesterday’s close.

According to FDA data, Indian companies have been facing frequent recalls over recent months. Some of the major domestic drug manufacturers, such as Ranbaxy Laboratories, Glenmark Pharmaceuticals, Dr Reddy’s Laboratories and Sun Pharmaceutical Industries, have recalled their products from the US, the world’s largest drug market, in the past seven months.

In November last year, Ranbaxy had recalled its revenue-churning generic version of Lipitor from the US, after it suspected the presence of tiny glass particles in some of the batches. While the company recently restored supplies of the medicine for its US facility, it is yet to do so from its Mohali unit in India. More recently, Dr Reddy’s Labs and Glenmark had to recall some product from the US, after complaints.

While recalls are considered part of business in the pharmaceutical sector, experts say more frequent and serious recalls might create trouble for Indian companies in the US.
BROKEN CHIPPED AND RECALLED

• Total US market for venlafaxine hydrochloride tablets, estimated at $2 billion annually
• These tablets are a generic alternative of Pfizer’s Effexor
• Venlafaxine hydrochloride used to treat depression
• Cadila Health launched the drug in the US in 2008