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    Tag: usfda

    You Searched For "usfda"
    Hetero Labs recalls over 15.90 lakh bottles of hypertension drug from US

    Hetero Labs recalls over 15.90 lakh bottles of hypertension drug from US

    Ruby Khatun Khatun30 Aug 2018 11:26 AM IST
    New Delhi: Drug firm Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets used for the treatment of hypertension from the American...
    Unichem Labs gets 4 observations from USFDA for Roha facility

    Unichem Labs gets 4 observations from USFDA for Roha facility

    Ruby Khatun Khatun8 Aug 2018 10:30 AM IST
    New Delhi: Drug firm Unichem Laboratories said the US health regulator has made four observations after inspection of its active pharmaceutical...
    Morepen labs gets USFDA approval for 2 bulk drug manufacturing units

    Morepen labs gets USFDA approval for 2 bulk drug manufacturing units

    Ruby Khatun Khatun1 Aug 2018 10:47 AM IST
    New Delhi: Morepen Laboratories Ltd. has received USFDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing...
    Alkem Labs gets EIR from USFDA for its Daman facility

    Alkem Labs gets EIR from USFDA for its Daman facility

    Ruby Khatun Khatun25 July 2018 10:15 AM IST
    New Delhi: Drug firm Alkem Laboratories said the US health regulator has issued an establishment inspection report (EIR) for its Daman...
    USFDA approves Mylan, Biocon

    USFDA approves Mylan, Biocon's Fulphila, the first biosimilar to Neulasta

    Ruby Khatun Khatun6 Jun 2018 10:30 AM IST
    HERTFORDSHIRE/PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's...
    Dr Reddy

    Dr Reddy's Lab shares gain 3 percent on zero USFDA observations for Srikakulam plant

    Ruby Khatun Khatun5 Jun 2018 10:30 AM IST
    New Delhi: Shares of Dr Reddys Laboratories rose by nearly 3 percent after the company said the USFDA has completed its API Srikakulam plant audit...
    Zydus Cadila gets USFDA nod for skin ointment, stomach ailment drug

    Zydus Cadila gets USFDA nod for skin ointment, stomach ailment drug

    Ruby Khatun Khatun28 May 2018 10:30 AM IST
    New Delhi: Zydus Cadila has received final approval from the US health regulator to market Nystatin ointment and Omeprazole and Sodium Bicarbonate...
    Lupin gets USFDA nod to market Tetrabenazine tablets

    Lupin gets USFDA nod to market Tetrabenazine tablets

    Ruby Khatun Khatun24 April 2018 10:15 AM IST
    New Delhi: Drug firm Lupin said it has received approval from the US health regulator to market in America its Tetrabenazine tablets used for the...
    DRL recalls 80,000 plus bottles of Atorvastatin from US due to quality concerns

    DRL recalls 80,000 plus bottles of Atorvastatin from US due to quality concerns

    Medical Dialogues Bureau9 Feb 2018 11:28 AM IST
    HYDERABAD: Dr. Reddy's Laboratories has initiated a voluntary recall of over 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and...
    SEBI slaps Rs 50 lakh penalty on Jubilant Life Sciences and 4 others

    SEBI slaps Rs 50 lakh penalty on Jubilant Life Sciences and 4 others

    Ruby Khatun Khatun2 Feb 2018 12:21 PM IST
    New Delhi: SEBI imposed a total fine of Rs 50 lakh on Jubilant Life Sciences, its three promoter entities and a director for violation of norms...
    Pharma sector earnings to remain muted in Dec quarter: Edelweiss Securities

    Pharma sector earnings to remain muted in Dec quarter: Edelweiss Securities

    Ruby Khatun Khatun7 Jan 2018 10:00 AM IST
    New Delhi: Pharma sector's December quarter revenue is estimated to remain flat, while profits are likely to slip owing to decline in US businesses...
    Morepen Labs gets USFDA nod for asthma drug

    Morepen Labs gets USFDA nod for asthma drug

    Ruby Khatun Khatun21 Dec 2017 2:09 PM IST
    New Delhi: Morepen Laboratories said the US health regulator has given approval to Montelukast Sodium, used in managing asthma symptoms and seasonal...
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