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About 263 results for "us food and drugs administration"

FDA approves Pfizer#39;s leukaemia drug, Mylotarg
Money Control

FDA warns of death, liver injury risks from Intercept's drug

The U.S. Food and Drug Administration (FDA) warned on Thursday that Intercept Pharmaceuticals Inc’s drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death. The U.S. Reuters, 22 hours ago

254 images for us food and drugs administration

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Many drug companies fail to conduct timely safety checks on medicines after FDA approval

(Reuters Health) - In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A new analysis in the New England ...
 Reuters22 hours ago Three reasons why pacemakers are vulnerable to hacking  catchnews.com1 week ago FDA approves Medicines Co's urinary tract infection drug  Reuters3 weeks ago
Money Control

Lupin#39;s US arm recalls 12,888 bottles of ulcer drug in US

The reason for the recall is current Good Manufacturing Practise (CGMP) deviations, United States Food and Drug Administration (USFDA) said in its latest Enforcement Report.
 Money Control1 week ago Lupin recalls contraceptive Mibelas 24 Fe pills in US  Money Control4 weeks ago Biocon tanks 9% after USFDA issues Form 483 with 10 observations to Bengaluru unit  Money Control1 month ago Lupin recalls 12,480 bottles of anti-depressant drug from US  Business Standard2 months ago
Money Control

US FDA makes 3 observations after inspecting Dr Reddy#39;s plant in UK

The audit of API Mirfield plant in the UK by the US Food and Drug Administration (FDA) was completed on Friday, Dr Reddy#39;s said in a regulatory filing to stock exchanges.
 Money Control6 days ago Torrent Pharma falls over 3.5% as US FDA issues 5 observations to Dahej plant  Money Control2 months ago
Money Control

Cadila Healthcare soars 5% on zero observations from USFDA for Moraiya unit

The US Food and Drug Administration has issued zero observations for Moraiya unit (Gujarat) after its re-inspection.
 Money Control2 weeks ago Cadila Healthcare gains over 2% on USFDA approval for anti-dementia medicine  Money Control2 weeks ago USFDA hikes fee for processing ANDA by USD 1 lakh for FY18  Business Standard3 weeks ago USFDA clears marketing of Zydus Cadila anti-hypertension drug  Money Control4 weeks ago
Money Control

Laurus Labs rises 3% on completion of USFDA inspection

The company has completed the US Food and Drug Administration (USFDA) inspection of its API facilities in Units 1 and 3 at Parawada, Visakhapatnam, Andhra Pradesh with two observation which are only procedural in nature.
 Money Control1 month ago Laurus Labs in pink of health on completion of USFDA inspection  Business Standard1 month ago

Lupin#39;s Aurangabad plant undergoes USFDA inspection

During the inspection, the US Food and Drug administration (USFDA) issued one 483 observation, Lupin said in a statement.
 Money Control1 month ago Lupin gets inspection report from USFDA for Aurangabad unit  Business Standard1 month ago USFDA issues EIR for Granules India's Gagillapur plant  Business Standard1 month ago Lupin may advance as Goa facility clears US FDA inspection  Business Standard1 month ago
Money Control

Natco Pharma gets EIR from USFDA for Kothur unit

Natco Pharma announced the receipt of successful Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility at Kothur Unit, Telangana, India, during the period January ...
 Money Control2 months ago Natco Pharma receives EIR from USFDA, stock up 1.05%  Money Control2 months ago Orchid Pharma gets EIR from USFDA for its Alathur facility  Business Standard1 day ago
Money Control

Divis Labs zooms 20% as USFDA to lift import alert on unit-II at Visakhapatnam

The US Food and Drug Administration issued an import alert under clauses 99-32 and 66-40 in March of 2017.
 Money Control2 months ago Resolved all issues leading to USFDA import alert on Vizag unit: Divis Labs  Business Standard2 days ago Divi's Lab shares jump 20% in intra-day; later settles 8% up  Business Standard2 months ago USFDA to lift import alert on Visakhapatnam unit: Divi's Labs  Business Standard2 months ago
Money Control

Lupin launches generic conjunctivitis treatment medicine in US

The launch follows receipt of approval from the US Food and Drug Administration (USFDA) earlier for Moxifloxacin Hydrochloride Ophthalmic solution 0.5 per cent, the company said in a statement. The product is produced at Lupin#39;s Pithampur manufacturing ...
 Money Control2 months ago Lupin shares up nearly 4% on drug launch  Business Standard2 months ago
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