Tuesday, December 3, 2013

U.S. FDA Bans Imports From Wockhardt Facility

MUMBAI—The U.S. Food and Drug Administration banned imports from one of the plants of Indian drug maker Wockhardt Ltd. in the latest example of increased global scrutiny of Indian generic drug makers.
Drug regulators in the U.S., the U.K. and elsewhere have been taking a closer look at India's drug companies, which are now the largest supplier of generic drugs to the U.S. and some other countries.
The U.S. FDA put on an import alert on drugs made by Wockhardt's Chikalthana plant in western India, the agency's website showed Wednesday. The alert blocks some imports from facilities that haven't met current good manufacturing practices, the FDA said. Five products from the Chikalthana plant have been excluded from the ban, Wockhardt said.
In May, the U.S. Food and Drug Administration had imposed a similar ban on products from Wockhardt's Waluj plant in western India after it failed a safety inspection. The U.S. agency didn't elaborate on the problems it found.
In a filing to Indian stock exchanges Wednesday, Wockhardt said its lucrative drug Metoprolol XR is under the new import alert. The drug is a generic copy of TOPROL-XL, made by AstraZeneca             » PLC to treat hypertension and heart failure.
The facility also makes Lamotrigine, said Prakash Agarwal, an analyst who covers the Indian company out of Mumbai for Malaysian investment bank CIMB Group. Lamotrigine is the generic name for the brand Lamictal XR, used in the treatment of epilepsy. Wockhardt hasn't said whether Lamotrigine is covered under the new FDA alert.
Wockhardt's "high margin U.S. business will see a decline," with total revenues falling by $180 million a year for the next two years because of the alert, he said.
A Wockhardt spokesman in Mumbai declined to comment. The company hasn't made public how much each drug contributes to its revenue.

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