Mumbai : Wockhardt shares slumped 15 per cent after the USFDA made nine ‘observations’ highlighting violations of its norms at the drug maker’s new facility at Shendra in Aurangabad and recall of 62,555 bottles of its antibiotic tablets by PD-Rx Pharmaceuticals in the US market.
Shares of the company opened on a weak note and tanked 15 per cent to touch an intra-day low of Rs 1,257.10 on the BSE. Finally, the scrip of the company ended the day at Rs 1,288.40, down 14.98 per cent. On NSE, the stock opened at Rs 1,516.70 and then fell 15.04 per cent to touch an intra-day low of Rs 1,251.60, down 17.38 per cent. The stock finally closed at Rs 1,287.00, down 15.04 per cent.
Without disclosing details, Wockhardt Ltd said in a regulatory filing: “The Shendra manufacturing unit is a new facility and presently there are no supply of products from the said unit to the US markets.”
The observations were made by the USFDA in the form of Form 483, which is issued to firm management at the conclusion of an inspection its investigator, highlighting any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Besides, it emerged on Thursday that 62,555 bottles of anti-biotic Azithromycin tablets manufactured by Wockhardt are being recalled by PD-Rx Pharmaceuticals Inc in the US market. The tablets are in the strengths of 250 mg (45,022 bottles) and 500 mg (17,533 bottles).