Lupin nosedives after USFDA issues warning letters for Goa & Indore sites

Lupin slumped 16.91% at Rs 859.70 at 14:00 IST after the company announced that a combined warning letter was issued by the US drug regulator for the company's Goa and Indore, Pithampur Unit II, sites.

The announcement was made during market hours today, 7 November 2017.

Meanwhile, the S&P BSE Sensex was down 341.41 points or 1.01% at 33,389.78.

High volumes were witnessed on the counter. On the BSE, 21.34 lakh shares were traded on the counter so far as against the average daily volumes of 1.36 lakh shares in the past two weeks. The stock had hit a low of Rs 851.20 so far during the day, which is also a 52-week low for the stock. The stock had hit a high of Rs 1,044 in intraday trade. The stock had hit a 52-week high of Rs 1,572.25 on 6 February 2017.

The stock had underperformed the market over the past one month till 6 November 2017, falling 0.73% compared with 6.03% gains in the Sensex. The scrip had also underperformed the market in the past one quarter, rising 4.25% as against Sensex's 4.35% rise. The scrip had also underperformed the market in the past one year, dropping 27.18% as against Sensex's 23.67% rise.

The large-cap company has equity capital of Rs 90.38 crore. Face value per share is Rs 2.

Lupin said that the company has received warning letter issued by the United States Food & Drug Administration (USFDA) yesterday, 6 November 2017, for the company's formulation manufacturing facilities at Goa and Indore, Pithampur II.

The company had responded to all the observations after earlier receiving 3 Form 483 observations in Goa on 7 April 2017 and 6 Form 483 observations in Pithampur Unit II on 19 May 2017.

The company said that it is deeply disappointed to have received the current outcome. While there will be no disruption of existing product supplies from either of these locations, there will likely to be a delay of new product approvals from these two facilities.

The company said that it upholds quality and compliance issues with utmost seriousness and remains fully committed to be compliant with cGMP quality standards across all its facilities. The company plans to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest.

Lupin's consolidated net profit fell 31.3% to Rs 455.01 crore on 8% decline in net sales to Rs 3874.16 crore in Q2 September 2017 over Q2 September 2016.

Lupin is a transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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