Recall is on detection of trace amounts of an impurity found in an API manufactured by Zhejiang Huahai Pharma
Ahmedabad-headquartered Torrent Pharmaceuticals, among the best performing pharma stocks, is voluntarily recalling 14 lots of high blood pressure medicine Valsartan in the US.
The reason for the recall had been stated as an impurity, N-nitrosodimethylamine (NDMA), detected in the active pharmaceutical ingredients (API). NDMA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen by International Agency for Research on Cancer (IARC).
According to the website of US Food and Drug Administration (FDA), Torrent is voluntarily recalling Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an API manufactured by Zhejiang Huahai Pharmaceuticals. However, the company has not received any reports of adverse events to this recall, it said.
Valsartan is used for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control high blood pressure.
The website said the tablets were distributed nationwide to Torrent’s wholesale, distributor, repackager and retail customers.
The company, which acquired Unichem Laboratories in November 2017, on Friday touched a record 52-week high on BSEbefore closing at Rs 1,766.70 per scrip, up 3.98% the previous close.
Torrent Pharma has risen 41.57% since April 1, compared with a 14.11% rise in the S&P BSE Healthcare Index.
A research report by IDBI Capital on August 3 said Torrent has given a strong set of numbers for the June quarter result across all regions. The domestic business grew 78.9%, driven by better than expected growth across all segment (chronic focused segment supporting the growth).
Brazil continues to grow ahead of the industry in spite of the discontinuation of a product.
US business grew 22.8% year on year (yoy), driven by a launch. The report said the management has guided 10 launches this fiscal in the US.
During the first quarter, ex-biopharm growth in US was 12% y-o-y and erosion in the base business single digit..
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- Recall is on detection of trace amounts of an impurity found in an API manufactured by Zhejiang Huahai Pharma
- However, the company has not received any reports of adverse events to this recall
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Valsartan is used for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control high blood pressure.
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