In yet another blow to drug maker Wockhardt Ltd, US 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 BSE, the company said it has received a warning letter from 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, the US Food and Drug Administration (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 USD 100 million due to the import alert.
Later in October, UK'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came under UKMHRA action after its Chikalthana facility in Maharashtra, from where good manufacturing certification was withdrawn, and the export-oriented plant at Waluj, which came under an import alert in July this year.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 Ltd were trading at Rs 428.45 per scrip in the afternoon trade, down 9.23 per cent from the previous close on the BSE.