Alkem Lab drops after receiving observations from USFDA for API facility

Alkem Laboratories dropped 3.84% to Rs 1,611 at 12:35 IST on BSE after the company received the inspection report containing three 483 observations from the US drug regulator for manufacturing facility.

The announcement was made during market hours today, 12 December 2016.

Meanwhile, the S&P BSE Sensex was down 130.87 points or 0.49% at 26,616.31.

More than usual volumes were witnessed on the counter. On the BSE, 15,540 shares were traded in the counter so far as against average daily volume of 9,124 shares in the past one quarter. The stock had hit a high of Rs 1,685 and a low of Rs 1,588 so far during the day. The stock had hit a record low of Rs 1,175 on 2 May 2016. The stock had hit a record high of Rs 1,852.95 on 29 September 2016.

The stock had outperformed the market over the past one month till 9 December 2016, rising 1.48% compared with the Sensex's 1.85% fall. The scrip had also outperformed the market in past one quarter, gaining 4.47% as against the Sensex's 7.12% fall.

The large-cap company has equity capital of Rs 23.91 crore. Face value per share is Rs 2.

Alkem Laboratories announced that United States Food & Drug Administration (USFDA) had conducted an inspection at the company's active pharmaceutical ingredient manufacturing facility located at Ankleshwar, India from 5 December to 9 December 2016.

The company has received the inspection report from the USFDA which contains three 483 observations after the inspection. The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is proposed to be filed within the timeline stipulated by USFDA.

An FDA form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Alkem Laboratories' consolidated net profit rose 6% to Rs 282.83 crore on 18.6% growth in net sales to Rs 1615.01 crore in Q2 September 2016 over Q2 September 2015.

Alkem Laboratories is a pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.

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