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Cadila Healthcare slumps on getting warning letter from USFDA

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Last Updated : Jan 01 2016 | 12:01 AM IST

Cadila Healthcare fell 14.47% to Rs 329.40 at 11:04 IST on BSE after the company said that it received a warning letter from the US drug regulator relating to its Moraiya formulation facility and Ahmedabad API facility.

The announcement was made during trading hours today, 31 December 2015.

Meanwhile, the BSE Sensex was up 37.28 points, or 0.14%, to 25,997.31.

On BSE, so far 19.29 lakh shares were traded in the counter, compared with an average volume of 1.27 lakh shares in the past one quarter.

The stock hit a high of Rs 385.40 and a low of Rs 320.45 so far during the day. The stock hit a record high of Rs 454.40 on 23 October 2015. The stock hit a 52-week low of Rs 285.02 on 5 February 2015.

The stock had underperformed the market over the past one month till 30 December 2015, sliding 3.48% compared with 0.71% decline in the Sensex. The scrip had also underperformed the market in past one quarter, falling 7.97% as against Sensex's 0.74% fall.

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The large-cap company has an equity capital of Rs 102.37 crore. Face value per share is Re 1.

Cadila Healthcare said that it has received a warning letter issued by the US Food and Drug Administration (USFDA) relating to the company's Moraiya formulation facility and Ahmedabad active pharmaceutical ingredients (API) facility (Zyfine).

The company said that it takes quality and compliance matters very seriously and stand by its commitment to fully comply with cGMP (Current Good Manufacturing Practice) quality standards across all its facilities. The company said that it is working hard to ensure that the commitments made to the USFDA are fully completed. The company said that it will continue to take all necessary steps to ensure that the USFDA is fully satisfied with its remediation of the above facilities. It added that its products in the market are safe and effective and it is committed to supply the quality products to its customers across the globe.

Cadila Healthcare further clarified that there are no products in the US market which use API of Zyfine facility.

The company further added that it will respond to USFDA to address the observations within the statutory time permitted in the letter. It is committed to resolve all the issues and revamp its quality systems and processes as the top most priority.

On consolidated basis, Cadila Healthcare's net profit rose 40.6% to Rs 390.91 crore on 15% growth in net sales to Rs 2373.80 crore in Q2 September 2015 over Q2 September 2014.

Cadila Healthcare is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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First Published: Dec 31 2015 | 11:07 AM IST

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