Ipca Labs will be in focus today as the USFDA lists serious deviations on Ratlam API facility. Archana Shukla has more details.
Ipca Laboratories will be in focus today as the USFDA lists six serious deviations on inspection done between July 14 and July 18 of the Ratlam API facility.
Two of the observations detailed severe data integrity issues in the plant. Moreover, there are observations indicating senior staff involvement in data falsification. Quality system issues also date back to 2011 inspection that cited similar issues.
There are issues overwriting previous raw data and falsifying batches being placed along with instances of manipulating integration parameters so as to achieve desirable results. Another instance posing serious threat was noted in the form 483 where USFDA states that they found analysts who were backdating or falsifying temperature records and when there were questioned on why they were doing it, they said, they were forced to falsify these records by the direct supervisor.
In addition, an event of power supply disconnect for four hours took place wherein the quality assurance assessment determined an out of trend for unknown impurity. Serious threats can be raised for Ipca Labs if these issues are not resolved satisfactorily as FDA has shown zero tolerance in the past for data integrity lapses. Similar lapses were also seen in Ranbaxy , Wockhardt , Strides Arcolab and the FDA has not taken very easily on them.
Ratlam facility is very important for Ipca because it supplies API both to Silvassa and Indore plant and they have voluntarily stopped shipments from that facility but if these issues are not taken care of, there is a possibility of a warning letter or an import ban by USFDA. Meanwhile, the company in the last call had said that they hope to resolve these issues in the next four-six months.
Ipca Labs stock price
On August 08, 2014, at 14:15 hrs Ipca Laboratories was quoting at Rs 691.50, down Rs 33.35, or 4.6 percent. The 52-week high of the share was Rs 906.90 and the 52-week low was Rs 609.00.
The company's trailing 12-month (TTM) EPS was at Rs 43.67 per share as per the quarter ended March 2014. The stock's price-to-earnings (P/E) ratio was 15.83. The latest book value of the company is Rs 157.02 per share. At current value, the price-to-book value of the company is 4.40.
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