In yet another blow to drug maker Wockhardt Ltd., U.S. health regulator has imposed restrictions on import of medicines produced at the company’s Chikalthana plant at Aurangabad in Maharashtra, the second unit of the firm to face such an action.
In a filing to the Bombay Stock Exchange, the company said it had received a warning letter from the US Food and Drug Administration (USFDA) for its manufacturing units located at L1, Chikalthana, Aurangabad, and B15, Waluj, Aurangabad.
“USFDA has also posted on its website an import alert on the manufacturing unit at L1, Chikalthana, Aurangabad. USFDA has however, excluded five products from import alert,” the filing added.
``Metoprolol XR (used for treating blood pressure) is under the import alert,’’ Wockhardt said.
“The company has already initiated several steps to address the observations made by the USFDA, and shall put all efforts to resolve the matter at the earliest,” it said.
In May, USFDA had also issued an import alert on the company’s Waluj facility which makes injectables and solid dosages.
The company had said it would take an annual hit of $100 million due to the import alert.
Later in October, the U.K.’s health regulator had imposed restrictions on import of medicines made at Wockhardt’s unit at Kadaiya in Nani Daman for violation of norms.
This was the third plant of the company that came under the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) action after its Chikalthana facility in Maharashtra, from where good manufacturing certification was withdrawn, and the export-oriented plant at Waluj, which came under an import alert in July this year.
Shares of Wockhardt plunged by nearly 9 per cent on Wednesday after the U.S. health regulator imposed restrictions. After losing a massive 13.98 per cent to Rs.406 intra-day, the drug major’s scrip finally ended the day at Rs.430.15, down 8.87 per cent on the BSE from its previous close.
The stock slumped 8.27 per cent to end at Rs.431 on NSE. In the process, the company’s market value eroded by Rs.460 crore to Rs.4,720 crore.
