Wockhardt plunges 10% on US FDA warning letter
The US FDA had earlier imposed an import alert on the company's Waluj plant in Maharashtra in May. UK drug regulator MHRA had this month recalled some medicines from the same plant citing manufacturing deficiencies it had identified.
July 22, 2013 / 13:28 IST
Moneycontrol Bureau
Shares of pharma major Wockhardt plunged 10 percent in morning trade on Monday following the company's update over the weekend that it has received a warning letter from the US Food and Drug Administration in relation to its facility in Waluj, Maharashtra, not meeting manufacturing guidelines.The warning letter follows an import alert, which the US drug regulator had issued on the plant in May this year. An import alert means detention of drugs without physical examination from firms, which have not complied with current good manufacturing practises, the drug regulator states.With reference to the earlier announcement dated May 24, 2013, regarding the import alert from the US FDA on the company's Waluj facility, the company has (now) received a warning letter, which lists the observations made during the inspection, Wockhardt said in a notice to stock exchanges on Saturday.The company has already initiated several corrective actions to resolve the same and If any additional measures are necessary, it would take them to squarely address all concerns, it added.Apart from the US FDA, Wockhardt's Waluj facility, which makes injectables and solid dosages, is also under scrutiny from UK's drug regulator. UK's MHRA (Medicines and Healthcare Products Regulatory Authority) had also identified manufacturing deficiencies and earlier this month recalled some medicines made by Wockhardt at the same plant. "The deficiencies identified during a routine inspection in March included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten," MHRA had said.At 10:00hrs, Wockhardt was down 8.4 percent at Rs 813.80 on NSE. The stock had hit a 52-week low of Rs 780.05 earlier in the session.Since the US FDA imposed the import alert on May 24, the stock has tumbled more than 32 percent. Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
