UPDATE 2-India's Wockhardt shares plunge after FDA ban on another plant
* Chikalthana plant had US sales of $230 mln last fiscal year
* Shares fall as much as 13.5 percent after latest import ban
* Company says FDA's ban excludes five drugs from Chikalthana
(Adds company and analyst comments, drug details and details on rivals)
MUMBAI, Nov 27 (Reuters) - India's Wockhardt Ltd faces a sharp drop in market share and delays in new launch approvals after a second plant operated by the generic drugmaker was hit by the U.S. Food and Drug Administration's "import alert", effectively a ban.
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, one of its key export facilities, comes amid a slew of regulatory rebukes in recent months, which has wiped off nearly three-quarters of the company's share value this year.
The United States is Wockhardt's No.1 market and accounted for 43 percent of its revenue in the quarter ended in September.
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.
India is the biggest overseas source of medicines for the United States and is home to more than 150 FDA-approved plants. Pharmaceutical exports from India to the United States rose nearly 32 percent last year to $4.23 billion.
Wockhardt said in a statement the company had initiated several steps to address the observations made by the FDA and would "put all efforts" to resolve the matter at the earliest. It did not give details.
Wockhardt's Chikalthana facility makes generic versions of AstraZeneca's hypertension drug Toprol, and the plant generated $230 million in U.S. revenue in the last fiscal year that ended in March, or about a quarter of its total sales.
The FDA import ban on the Chikalthana facility excludes five products, but includes Toprol generic, the company said.
Mylan Inc, Actavis Inc, the U.S. drugmaker previously known as Watson Pharmaceuticals, and India's Dr Reddy's Laboratories also sell the generic version of Toprol in the United States.
Dr Reddy's shares rose as much as 1.8 percent on Wednesday in a falling market on hopes of increase in its market share of the drug after the latest FDA action on the Wockhardt facility, sector analysts said.
Wockhardt has filed for 43 new generic drug approvals with the U.S. regulator from its plants in Waluj and Chikalthana, both of which have now been banned from shipping drugs to the United States.
"If they are out of the market for a long time then someone else will take their position. It will take time for them to rebuild the brand," said Daljeet Kohli, head of research at brokerage IndiaNivesh in Mumbai. "The import alert will mean loss of market share and no visibility on the future product pipeline."
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.
Wockhardt shares fell as much as 13.5 percent on Wednesday. The stock was trading down nearly 8.4 percent at 430.35 rupees at 0731 GMT, taking its losses to more than 72 percent so far this year.
The Wockhardt stock is the biggest loser this year among its 589 peers in the Asia Pacific healthcare sector with a market value of more than $100 million, according to Thomson Reuters data.
SHIFT TO OTHER PLANTS
The US regulator inspected the Chikalthana plant, hit by the latest regulatory action, in July and had made some observations about the manufacturing practices, the company said in August.
Britain's Medicines and Healthcare Products Regulatory Agency withdrew its good manufacturing practice certificate for the Chikalthana plant last month, and instead issued a restricted certificate.
The United States and Europe accounted for three-quarters of Wockhardt's sales in the last fiscal year that ended in March.
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.
The company, which has 12 manufacturing facilities globally, has been expanding capacity at some of its other Indian plants to cushion the impact of the regulatory actions in two of its largest markets.
It is, however, not likely to be able to generate revenue soon from a shift to other plants as the products would require fresh approvals from overseas health regulators, analysts have said.
(Additional reporting by Abhishek Vishnoi in MUMBAI and Tripti Kalro in BANGALORE; Editing by Matt Driskill)