Wockhardt hits fresh 52-week low; down over 30% in July on USFDA concerns

NEW DELHI: Shares in Mumbai-based drug maker Wockhardt plunged another 10 per cent to hit their fresh 52-week low of Rs 594.85 on Wednesday, after details of a warning by the US Food and Drug Administration ( USFDA) emerged over the company's manufacturing practices.

The warning letter is a follow-up of an import alert that Wockhardt received for its injectables plant at Waluj. Following the warning, the UK's drug regulator Medicines and Healthcare Products Regulatory Agency also issued a similar warning for the drugs earlier this month.

At 10:20 a.m.; Wockhardt was trading 8.9 per cent lower at Rs 602.10. It had hit a 52-week low of Rs 594.85 and a high of Rs 639.90 in trade today. The stock has plunged over 30 per cent so far in the month of July on USFDA concerns.

In a letter to the company on July 18, the US drug regulator said Wockhardt deliberately withheld "truthful information and delayed and limited inspection" of its Waluj plant in Maharashtra.

"These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) and 501(j) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B) and 351(j), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing process," the FDA said in its letter.

Analysts say the FDA charges may engulf the company's other facilities, threatening the drugmaker's long-term prospects, ET said in a report.

In an email to ET, Wockhardt said it is taking corrective measures.

"Wockhardt has already initiated the process of taking corrective measures, including appointment of a leading US-based consultant for its Waluj facility in Aurangabad. The consultant has extensive experience and expertise in CGMP (Current Good Manufacturing Process) and will work with the Wockhardt team to address issues raised by the USFDA," managing director Murtaza Khorakiwala said in the email.