MUMBAI (Reuters) - A second plant operated by generic drugmaker Wockhardt Ltd was hit by the U.S. Food and Drug Administration with an "import alert", effectively a ban, clouding the company's earnings outlook and sending its shares down as much as 13.5 percent.
An "import alert" results in the detention without physical examination of drugs from firms that have not met so-called good manufacturing practices, according to the FDA website.
The latest FDA action against Wockhardt's Chikalthana plant in western India comes amid a slew of regulatory rebukes this year. The plant was last month hit by the British drug regulator's curb on imports over manufacturing deficiencies.
Wockhardt shares fell as much as 13.5 percent on Wednesday. The stock was trading down 8.6 percent at 429.40 rupees at 11.27 am, taking its losses to more than 72 percent so far this year.
A spokesman for Wockhardt declined to comment on the FDA import alert.
The United States and Europe accounted for three-quarters of Wockhardt's sales in the last fiscal year that ended in March.
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Indian medicine makers, which produce nearly 40 percent of generic and over-the-counter drugs for the United States, have recently been battered by a rash of regulatory actions including a record fine for Ranbaxy Laboratories Ltd .
In May, the FDA imposed ban on the Waluj plant of Wockhardt after inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area.
The US regulator had inspected the Chikalthana plant, hit by the latest regulatory action, in July and had made some observations about the manufacturing practices, the company said last month.
Wockhardt, which has 12 manufacturing facilities globally, generated $40 million in sales by supplying medicines from its Chikalthana plant to the United States, its largest market and one that accounted for 43 percent of revenue in the quarter ending in September.
In October, Britain's Medicines and Healthcare Products Regulatory Agency withdrew its good manufacturing practice certificate for the Chikalthana plant, and instead issued a restricted certificate.
Wockhardt faces a year or more to get U.S. and British regulators to end curbs on its shipments of medicines to the two countries, the drugmaker said last month after posting its smallest profit in six quarters.
India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players. Pharmaceutical exports from India to the United States rose nearly 32 percent last year to $4.23 billion.
(Reporting by Sumeet Chatterjee and Aradhana Aravindan; Editing by Matt Driskill)