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    Tag: us health regulator

    You Searched For "US health regulator"
    Natco Pharma gets 6 USFDA observations for API facility near Hyderabad

    Natco Pharma gets 6 USFDA observations for API facility near Hyderabad

    Medical Dialogues Bureau13 Aug 2019 1:16 PM IST
    Natco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
    Natco Pharma gets zero USFDA observations for Chennai facility

    Natco Pharma gets zero USFDA observations for Chennai facility

    Medical Dialogues Bureau16 July 2019 9:30 AM IST
    Natco Pharma announced "successful completion of regulatory inspection from the US Food and Drug Administration (USFDA) for its active pharmaceutical...
    Dr Reddys gets two USFDA observations for Vizag plants

    Dr Reddys gets two USFDA observations for Vizag plants

    Farhat Nasim24 Jun 2019 11:09 AM IST
    Hyderabad: City-based Dr Reddy's Laboratories (Dr Reddys/ DRL) has reportedly fallen under the US health regulator's scanner. The company has been...
    Zydus Cadila gets USFDA nod for Phentermine Hydrochloride orally disintegrating tablets

    Zydus Cadila gets USFDA nod for Phentermine Hydrochloride orally disintegrating tablets

    Medical Dialogues Bureau26 April 2019 8:59 AM IST
    Phentermine Hydrochloride orally disintegrating tablets is used together with diet and exercise to treat obesity (overweight) in people with risk...
    USFDA inspected Goa facility, no observations issued: Indoco Remedies

    USFDA inspected Goa facility, no observations issued: Indoco Remedies

    Farhat Nasim30 March 2019 11:52 AM IST
    The US Food and Drug Administration (USFDA) has cleared the Goa-based sterile manufacturing facility of Indoco Remedies for finished dosages.New...
    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

    Farhat Nasim8 Feb 2019 11:40 AM IST
    Fulvestrant injection is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added. The Faslodex...
    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets

    Medical Dialogues Bureau24 Jan 2019 9:30 AM IST
    Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets...
    Dr Reddy

    Dr Reddy's gets four observations from USFDA for Andhra plant

    Medical Dialogues Bureau19 Jan 2019 9:30 AM IST
    "The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....
    USFDA issues 4 observations for Torrent Pharmaceuticals Indrad plant

    USFDA issues 4 observations for Torrent Pharmaceuticals Indrad plant

    Ruby Khatun Khatun15 May 2017 12:52 PM IST
    New Delhi: Drug firm Torrent Pharmaceuticals said the US health regulator has issued four observations after inspection of its Indrad facility in...
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