Neuland Labs drops after 5 observations from USFDA

Neuland Laboratories was down 4.08% to Rs 500 at 09:18 IST on the BSE after the company announced that it has received five observations from the US drug regulator after inspection of facility at Bonthapally, Telangana.

Jun 24, 2019 03:06 IST capital market

The announcement was made after market hours on Friday, 21 June 2019.

Meanwhile, the S&P BSE Sensex was up by 91.05 points, or 0.23% to 39,285.54.

On the BSE, 356 shares were traded in the counter so far compared with average daily volumes of 1079 shares in the past two weeks. The stock had hit a high of Rs 517.20 and a low of Rs 490.80 so far during the day. It hit a 52-week high of Rs 824.55 on 26 February 2019 and a 52-week low of Rs 431.45 on 11 December 2018.

Neuland Laboratories said that the United States Food and Drug Administration (USFDA) had inspected the companys manufacturing facility at Bonthapally, Hyderabad from 17 to 21 June 2019. The inspection has been completed with five observations given under form 483.

The company said that it has already initiated corrective and preventive actions for the observations and is confident of satisfying the FDA within the stipulated time. This is a regular surveillance audit by USFDA, and no data integrity issues were observed during the inspection, Neuland Laboratories said.

Neuland Laboratories net profit fell 16.4% to Rs 6.73 crore on a 7.8% rise in the net sales to Rs 172.66 crore in Q4 March 2019 over Q4 March 2018.

Neuland Labs has been at the forefront of manufacturing APIs through its cGMP manufacturing facilities, working with customers in close to 80 countries for over 35 years.

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