Lupin slides after USFDA closes inspection at Mandideep with observations

Lupin fell 2.37% to Rs 867 at 14:10 IST on BSE after the company said that US drug regulator has made a total of 22 observations after inspection of its facilities located at Mandideep in Madhya Pradesh.

The announcement was made during market hours today, 5 December 2018.

Meanwhile, the S&P BSE Sensex was down 219.29 points, or 0.61% to 35,915.02.

On the BSE, 1.46 lakh shares were traded in the counter so far compared with average daily volumes of 1.85 lakh shares in the past two weeks. The stock had hit a high of Rs 889.20 and a low of Rs 849.60 so far during the day.

The stock hit a 52-week high of Rs 986 on 10 September 2018. The stock hit a 52-week low of Rs 723.55 on 15 May 2018.

The company announced today, 5 December 2018, the completion of United States Food and Drug Administration (US FDA) inspections carried out at its Mandideep location. Lupin's Mandideep location houses the company's cardiovascular "Pril" API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility. These inspections were carried out between November 26 and December 4,2018.

The inspection at Unit-2, the Cardiovascular "Pril" API facilities closed with 4 observations. The inspection at Unit-I, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and 8 observations for the Cephalosporin Solid Oral Dosage Form facility.

The observations are largely procedural in nature with some gaps identified in the aseptic processing areas of the Cephalosporin API block and the company is confident of addressing them satisfactorily. As a company, Lupin has committed to an enhanced Quality Management System and Compliance Sustainability Plan. The Lupin Mandideep site is already executing the plan, which also serves to address some of the concerns raised during this inspection. There are no new DMF and ANDA applications pending for review or approval from Lupin's Mandideep facilities.

Further, Lupin announced the launch of Silodosin Capsules 4mg and 8mg, having received an approval from the United States Food and Drug Administration (USFDA) earlier. Lupin's Silodosin Capsules 4mg and 8mg; is the generic equivalent of Allergan's Rapaflo. An alpha-1 adrenergic receptor antagonist, it is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Rapaflo had annual sales of $198.5 million in the US (IQVIA MAT September 2018). The announcement was made after market hours yesterday, 4 December 2018.

On a consolidated basis, Lupin's net profit fell 41.24% to Rs 268.45 crore on 0.43% rise in net sales to Rs 3890.93 crore in Q2 September 2018 over Q2 September 2017.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APls globally.

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