According to news reports, US health regulator issued Form 483 with three observations to Lupin Goa plant. The US Food and Drug Administration inspected this plant between March 27 and April 7, 2017.
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The observations, as per reports, are- failure to review any unexplained discrepancy; no written procedures for production and process controls; control procedures that monitor output of manufacturing processes not established.
“Goa plant of the company contributed close to 50% of the US sales (around 25% of consolidated revenue) and accounted for 30 outstanding ANDAs and thus very important for Lupin growth plans. While it’s difficult to assess the impact on the same as the company still has time to respond back to the queries and also, since queries are small and can be responded,” said Sarabjit Kour Nangra, VP Research- Pharma, Angel Broking.
As of now we are not changing the estimates and maintain our BUY rating with a price target of Rs 1809, the brokerage said in client note.
At 10:38 am; the stock was down less than 1% at Rs 1,325 on BSE against 0.32% decline in the S&P BSE Sensex. A combined 723,845 equity shares changed hands on the counter on BSE and NSE so far.
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