Medicines were made at two plants in Maharashtra
Mumbai, April 29, 2015
Wockhardt Ltd will recall all remaining batches of medicines in the US that were manufactured at two of its Indian plants before the US regulator imposed an import ban on the facilities.
The drug company said it was doing this as a remedial measure, “even though there is no evidence of risk to patient safety from the products currently available in the US market”.
The recall was not directed by the US Food and Drug Administration, Wockhardt Founder Chairman Habil Khorakiwala told mediapersons. Even as market analysts questioned the timing of the announcement, Khorakiwala clarified that the objective was to get back to normalcy faster.
The USFDA after its last inspection of Wockhardt’s facilities at Ll-Chikalthana and Waluj in Aurangabad (Maharashtra) had made some observations involving batches of products manufactured prior to the USFDA import alerts.
Between the two plants, 12-15 products would be impacted, Khorakiwala said, adding that the company was putting into place a third party to make them.
Khorakiwala did not put a number on the financial impact the latest move would have. However, he added, the company has not been exporting to the US over the past two years, when the import ban kicked in.
Further, the company said, the United Kingdom’s regulatory authority (MHRA, UK) has also restored the EU GMP (good manufacturing practices) certification of its potent product facility at Kadaiya, Daman.
Wockhardt shares closed down about 7 per cent on the BSE on Tuesday, at Rs.1,243. Business Line
