Pharma major Wockhardt slumped 10 percent on Friday on reports that the US Food and Drugs Administration had issued a 483 form through a routine course of inspection of one of its plants. The inspection was for its injectables facility in Aurangabad.
A form 483 is issued when the FDA observes any violation from standard manufacturing practices. This is, however, routine and may or may not result in any enforcement action by the US drug regulator, analysts say.
The management too says the issue is routine and can be resolved. More clarity is expected once US FDA reverts to its responses.
Even if the US FDA does end up sending a warning letter to Wockhardt, it would only affect new approvals in injectables and not the current revenue stream materially, according to a foreign brokerage. It is expecting less than 5 percent impact to earnings should this facility receive a warning letter.
Another domestic brokerage says the probability of the company receiving a warning letter is low and even if it does get such a letter, then its earnings will not be impacted much as it contributes to only 2 percent of the total sales.
Wockhardt closed down 10 percent at Rs 1,752 on NSE. The stock has declined over 13 percent in the last two days.
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