Search For "us fda"
Combating COVID-19: Dr Harsh Vardhan discusses progress on antibody drug -
Updated : 5 years, 10 months ago IST
New Delhi [India], May 4 (ANI): Union Health Minister Dr Harsh Vardhan on Monday discussed among other things the progress over Remdesivir -- antibody-drug recently approved by the US-FDA for emergency use to treat COVID-19 patients -- with the heads of Council of Scientific and Industria
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US FDA authorises emergency use of Remdesivir in coronavirus treatment
Updated : 5 years, 10 months ago IST
Washington D.C. [US], May 2 (Sputnik/ANI): The US Food and Drug Administration has authorized an emergency use of Remdesivir drug in coronavirus treatment, FDA head Stephen Hahn announced on Friday.
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RTPCR kits should be kept under 20 degrees temperature for better result:
Updated : 5 years, 11 months ago IST
New Delhi [India], April 20 (ANI): Indian Council of Medical Research (ICMR) on Monday said that RTPCR kits are US FDA approved and have good standards and these should be stored under 20-degree temperature for better result.
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Lupin's Aurangabad facility gets EIR from US FDA
Updated : 5 years, 11 months ago IST
Mumbai (Maharashtra) [India], Apr 3 (ANI): Pharma major Lupin Ltd said on Friday it has got an establishment inspection report (EIR) from the US Food and Drug Administration for its Aurangabad facility.
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Strides announces successful completion of US FDA inspection at flagship f
Updated : 5 years, 12 months ago IST
Bengaluru (Karnataka) [India], Mar 30 (ANI): Strides Pharma Science Ltd said on Monday it has received the establishment inspection report (EIR) conducted by the US Food and Drug Administration last month at the company's flagship facility.
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Cipla receives final approval for generic version of AstraZeneca Pharmaceu
Updated : 5 years, 12 months ago IST
Mumbai (Maharashtra) [India], Mar 27 (ANI/ PRNewswire): Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as "Cipla" today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40m
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Biocon's Biologics drug products facility gets nod from US FDA
Updated : 6 years, 4 months ago IST
Bengaluru (Karnataka) [India], Nov 5 (ANI): Biopharmaceuticals major Biocon Ltd said on Tuesday it has received an establishment inspection report from the US Food and Drug Administration (FDA) for its biologics drug product facility here, reaffirming its global scale manufacturing capabilit
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Japan's PMDA issues GMP certificate to Lupin's unit at Mandideep facility
Updated : 6 years, 5 months ago IST
Mumbai (Maharashtra) [India], Oct 9 (ANI): Pharma major Lupin Ltd on Wednesday announced the receipt of good manufacturing practice (GMP) certificate from the Pharmaceutical and Medical Devices Agency (PMDA) of Japan for its active pharmaceutical ingredient facility at Mandideep in Madhya Pr
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US FDA issues warning letter for Glenmark Pharmaceuticals facility in Badd
Updated : 6 years, 5 months ago IST
Mumbai (Maharashtra) [India], Oct 7 (ANI): The US Food and Drug Administration (US FDA) has issued a warning letter to Glenmark Pharmaceuticals for breach of norms at its facility at Baddi in Himachal Pradesh.
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US FDA issues warning letter for Lupin's Mandideep facility
Updated : 6 years, 6 months ago IST
Mumbai (Maharashtra) [India], Sep 19 (ANI): The US Food and Drug Administration (US FDA) has issued a warning letter to pharma major Lupin Ltd for its facility at Mandideep in Madhya Pradesh.
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Twin USFDA approvals for Morepen Labs' bulk drugs (API) facilities
Updated : 7 years, 7 months ago IST
New Delhi [India], July 30 (NewsVoir): Morepen Laboratories Ltd. has received US FDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing facilities situated in Himachal Pradesh.
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Axiostat becomes first indigenous wound care product to get US FDA clearan
Updated : 8 years ago IST
Bengaluru (Karnataka) [India], Feb 28 (Businesswire India): Giving a fillip to the Government's 'Make in India' initiative, Axiostat has become the first Indian wound care product to receive 510(K) FDA clearance in the US for its pioneering haemostatic dressing.
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