Strides Arcolab slides after receiving warning letter from USFDA

Strides Arcolab fell 3.63% to Rs 867.50 at 10:14 IST on BSE after the company said that one of its manufacturing facilities at Bangalore received a warning letter from the US drug regulator.

The announcement was made during trading hours today, 16 September 2013.

Meanwhile, the BSE Sensex was up 264.55 points, or 1.34%, to 19,997.31.

On BSE, 64,000 shares were traded in the counter compared with average volume of 81,886 shares in the past one quarter.

The stock hit a high of Rs 901 and a low of Rs 839 so far during the day. The stock hit a record high of Rs 1,224.90 on 5 December 2012. The stock hit a 52-week low of Rs 552.65 on 1 August 2013.

The stock had outperformed the market over the past one month till 13 September 2013, rising 9.38% compared with the Sensex's 2.62% rise. The scrip had, however, underperformed the market in past one quarter, gaining 2.63% as against Sensex's 4.81% rise.

The mid-cap company has an equity capital of Rs 59.11 crore. Face value per share is Rs 10.

Strides Arcolab said that the sterile manufacturing facility 2 (SFF) at Bangalore of Agila Specialties, a wholly-owned subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (US FDA).

The US FDA inspected SFF in the month of June 2013 and the inspection resulted in issuance of Form FDA 483 with observations. The company responded to the 483 observations by implementing corrective actions. Strides Arcolab said that the company is committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time.

Further, the oncology facility at Bangalore of Agila Specialties was also inspected recently by the USFDA and this facility has cleared the inspection with "Zero 483 status", Strides Arcolab said.

Strides Arcolab said that the company has 8 US FDA approved sterile manufacturing facilities.

Strides Arcolab reported net profit of Rs 2.16 crore in Q2 June 2013, as against net loss of Rs 19.90 crore in Q2 June 2012. Net sales declined 7.3% to Rs 150.83 crore in Q2 June 2013 over Q2 June 2012.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore. The company develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

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