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    • No issue of impurities...

    No issue of impurities in Losartan in India: Torrent Pharma

    Farhat NasimWritten by Farhat Nasim Published On 2018-12-26T14:58:30+05:30  |  Updated On 26 Dec 2018 2:58 PM IST
    No issue of impurities in Losartan in India: Torrent Pharma

    When questioned about the recalling of Losartan tablets sold in India, Jayesh Desai, Executive Director told IANS, “Currently, we do not have this issue in India.”


    Chennai: Unlike US, the Indian pharmaceutical major Torrent Pharmaceuticals Ltd is not facing any issue of impurities in its hypertension tablet Losartan manufactured and marketed in India, a senior official told IANS.


    Notably, two days ago the US Food and Drug Administration (USFDA) in a statement said,“Torrent Pharmaceuticals Limited is voluntarily recalling two lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.”


    As per US FDA, the impurity detected in the Active Pharmaceutical Ingredients(API) is N-nitrosodiethylamine (NDEA), which 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 as per International Agency for Research on Cancer (IARC) classification.


    To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall in India.


    Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.


    Also Read: Torrent Pharma issues voluntary nationwide recall of Losartan Potassium tablets: USFDA




    However, when questioned about the recalling of the Losartan tablets sold in India, Jayesh Desai, Executive Director told IANS, “Currently, we do not have this issue in India.”



    “Pharmaceutical products go through testing processes to ensure safety. This impurity was recently detected and we have developed a new method to measure it,” Desai added.


    Also Read: Torrent Pharma Q2 net profit dips 12 per cent to Rs 179 crore



    drugDrug RecallFDAIARCimpuritiesIndiaInternational Agency for Research on CancerLosartanmedicinesN-nitrosodiethylamineNDEApotassium tabletsTabletsTorrent PharmaUSUSFDA
    Source : With input

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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