Hope for Wockhardt on US regulator's inspection

USFDA inspected Wockhardt's other two units; the company hasn't received any notices so far

Drug maker Wockhardt, whose Waluj facility in Maharashtra came under an international regulatory scanner a month before, limiting its import revenue, is expected to get some relief.

According to sources, the US Food and Drug Administration (FDA) recently inspected the company's other two units, one in nearby Chikalthana and another a cephalosporin facility. “Since the company has not received any observations or warning letter so far from the FDA after the inspection, it is likely to receive approval for shifting products from Waluj to these facilities,” a source told Business Standard. This would help the company restart supplies of products to the US, barred after its Waluj facility, near Aurangabad, came under the FDA import alert for violation of manufacturing norms.

An email query sent to Wockhardt last Thursday did not elicit any response. Wockhardt makes injectibles and solid dosages from its Waluj facility. After receiving the import alert from the US regulator for its Waluj facility in July, the management had indicated it was anticipating an impact of around $100 million on an annual basis on consolidated revenue. It had also indicated a plan to shift products from Waluj to other facilities in Aurangabad and was expecting an inspection of these  in July-August.  

Apart from the US, the Mumbai-based maker is also facing trouble in Europe.  Following the FDA action, the UK drug regulator also imposed an import alert, stopping supplies from Waluj. The Medicines and Healthcare Products Regulatory Agency, the UK drug regulator, identified manufacturing deficiencies, including a risk of cross-contamination, and evidence of data falsification, at the facility during a routine inspection in March. The company had then said it might take a one-time hit of around £1.5 million due to the recall. Though the company’s Europe business contributes around 25 per cent to consolidated sales, the company maintained exports out of the Waluj plant were less than five per cent of UK sales and less than two per cent of its overall sales.