Jan 29, 2014, 10.25 PM IST
According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.
Tags Pharma major Lupin, Quinapril Tablets USP , US Food and Drug Administration (FDA), , Abbreviated New Drug Application
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Lupin recalls Quinapril tablets from US market
According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.
Like this story, share it with millions of investors on M3
Lupin recalls Quinapril tablets from US market
According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.
According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.
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In 2006, Lupin received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is indicated to treat hypertension.
"During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval," FDA said citing the cause for the recall. According to the US health regulator, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Both the drugs were manufactured by Lupin at its Goa facility. When contacted, Lupin in a statement said: "This is an old event and a voluntary recall for a small batch of Quinapril Tablets 5 mg and 10 mg strengths; a precaution on our part, and of no business consequence."
Lupin shares today settled lower by 1.14 percent at Rs 865.90 apiece on the BSE.
Lupin stock price
On January 29, 2014, Lupin closed at Rs 865.90, down Rs 9.95, or 1.14 percent. The 52-week high of the share was Rs 951.00 and the 52-week low was Rs 569.00.
The company's trailing 12-month (TTM) EPS was at Rs 40.17 per share as per the quarter ended September 2013. The stock's price-to-earnings (P/E) ratio was 21.56. The latest book value of the company is Rs 108.11 per share. At current value, the price-to-book value of the company is 8.01.
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