homehealthcare NewsOAI letter from USFDA for Lupin's Mandideep facility won't impact future earnings, says HDFC Sec

OAI letter from USFDA for Lupin's Mandideep facility won't impact future earnings, says HDFC Sec

The US Food and Drug Administration (USFDA) has classified the inspection at Lupin's Mandideep facility in Madhya Pradesh (MP) as 'official action indicated'. New approvals from this unit may be withheld. Amey Chalke, a research analyst at HDFC Securities, spoke to CNBC-TV18 about the development.

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By Latha Venkatesh  Mar 14, 2019 9:50:29 AM IST (Published)

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The US Food and Drug Administration (USFDA) has classified the inspection at Lupin's Mandideep facility in Madhya Pradesh (MP) as 'official action indicated' (OAI). New approvals from this unit may be withheld. Amey Chalke, a research analyst at HDFC Securities, spoke to CNBC-TV18 about the development.

“I don’t see any impact on the future earnings considering this is an Active Pharmaceutical Ingredients (API) plant and it does not have any pending filings from this plant for the US market. So if it is a warning letter, which is a very high probability, then the existing sales would not be affected and anyways there won’t be any new product sales coming in from that plant. So we don’t see any impact on our future earnings,” Chalke said on Thursday.
On whether the USFDA news will have a bearing on the stock, Chalke said, “I don’t see further pressure on the stock considering – if you value the domestic business, it contributes only 30 percent through the top line, you will get Rs 650 kind of a price. If it goes below Rs 70, the share price, then there is a strong cushion because of that domestic business. So I believe one should buy this stock at this time if it falls.”

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