FDA slaps import ban on Wockhardt facility
pharmafile | November 29, 2013 | News story | Manufacturing and Production | FDA, MHRA, Wockhardt, recall
The US Food and Drug Administration has banned imports of medicines made at Wockhardt’s Chikalthana plant in India that failed an inspection.
This is the second facility in the company’s network to come under the import alert. A restriction on imports from Wockhardt’s Waluj plant in western India was imposed earlier this year, with the UK’s Medicines and Healthcare products Regulatory Agency also ordering a wholesaler- and pharmacy-level recall of 15 medicines made there.
A notice on the FDA’s website recently indicated that all products made at Chikalthana are now subject to detention without physical examination (DWPE), apart from the antibiotic ceftriaxone, blood pressure medication enalapril maleate, divalproex sodium for epilepsy, antidepressant venlafaxine HCl and bethanechol chloride, an anticholinergic drug used to treat reflux oesophagitis and urinary retention.
In a filing with the Indian stock exchange Wockhardt suggested its extended-release metoprolol product – the generic version of AstraZeneca’s Toprol XL used to treat high blood pressure and heart failure – is one of the main products included in the ban.
A Bloomberg report suggests that Wockhardt has a 26% share of the $1.1 billion generic Topril-XL market and accounts for 14% of the company’s revenues. It appears that the ban also affects lamotrigine, a widely-prescribed epilepsy drug.
The effect of the import alert on Waluj had already made an impact on Wockhardt’s top-line financial results, with sales down 11% in the first half of fiscal 2014, reported at the end of last month.
Wockhardt’s managing director Murtaza Khorakiwala said at the time that “the current performance has been impacted due to the recent regulatory actions”.
In the wake of the latest announcement, analyst Prakash Agarwal of Malaysian bank CIMB said he expected Wockhardt’s revenues to be impacted by 14% to 16% in fiscal 2014 and 2015 and cut net profit by a third this year. US sales would be reduced by 25% in 2014 and 45% the following year, he predicted.
Wockhardt’s problems come against a backdrop of increased FDA scrutiny of plants making medicines overseas in recent years. The country’s biggest pharma company – Daiichi Sankyo subsidiary Ranbaxy – saw a third plant come under an import alert a few weeks ago.
Phil Taylor
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