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The stock of Wockhardt gained 3 per cent in trade on Thursday, after the company said that no observation was made by the US drug regulator in the recent inspection of its Chikalthana (Maharashtra) facility.
The US Food and Drug Administration in November 2013 had banned export of drugs from Wockhardt’s Chikalthana facility to the US, after the regulator observed quality issues with the products manufactured from this facility.
Following the recent re-inspection of the facility, the company expects to receive the US FDA’s nod to resume production and export from this facility. Resolution of the regulatory issues at Chikalthana will add over Rs 100 crore to Wockhardt’s revenue.
While a successful completion of inspection at the Chikalthana plant is positive, resolution of the regulatory issues involving its Waluj (Maharashtra) plant is critical for the company to resume the growth path.
According to the company, the US FDA had raised few observations during its recent inspection of the Waluj facility. The revenue loss on account of regulatory issues at the Waluj facility works out to about $100 million (Rs 625 crore).
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