Us Food And Drug Administration

USFDA issues warning letter to Glenmark Pharma for lapses at Goa plant

The US health regulator has pulled up drug maker Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish required laboratory control mechanisms, at its Goa-based manufacturing plant. In a warning letter addressed to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha, the US Food and Drug Administration (USFDA) pointed out various lapses at the company's Bardez-based facility in Goa, which produces drug formulations. The US Health regulator noted that the "warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals". It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated..." The USFDA inspected the manufacturing facility from May 12, 2022, to May 20, 2022. In the warning letter, the US health regulator pointed out the company's failure "to ...

Sun Pharmaceuticals' Halol plant gets 'import alert' from USFDA

The USFDA had imposed an import ban on the Halol plant in December 2015 too

World's most expensive drug approved to treat hemophilia at $3.5 mn a dose

CSL Behring's Hemgenix, administered just once, cut the number of bleeding events expected over the course of a year by 54%, a key study of the therapy found

US likely to authorise updated Covid booster shots for new Omicron variants

The US Food and Drug Administration is expected to approve new ovid-19 booster shots for newer Omicron strains this week, making them accessible to people in the country

Monkeypox bite: Bavarian Nordic is becoming a 'hot stock' again

Shares in the Danish biotech, which makes the only monkeypox vaccine approved by the US Food and Drug Administration, have gained 69% since hitting a low in early May

Lupin receives tentative approval from USFDA to market Ivacaftor tablets

The product is the generic equivalent of Vertex Pharmaceuticals' Kalydeco tablets, Lupin said in a statement

US allows more baby formula imports to fight shortage due to Abbot recall

The shortage stems from a February recall by Abbott that exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

The last two years saw limited physical inspections due to travel restrictions during the pandemic

US FDA authorises Pfizer-BioNTech booster shots for kids aged 12-15

The US FDA has expanded the emergency use authorisation for the Pfizer-BioNTech Covid-19 vaccine boosters to children aged 12 to 15.

Merck says it has first effective antiviral pill against Covid-19 pandemic

Drug cuts hospitalisation, deaths by 50%, shows an analysis of a late-stage trial

Explained: What FDA full approval to Pfizer-BioNTech vaccine means

The research to develop a safe and effective Covid-19 vaccine was accelerated in 2020

False negatives is not the only outcome: False Covid positive a concern too

False positives are generally very rare among tests that have been vetted by the Food and Drug Administration

Policy flip-flops may puncture India's image as 'pharmacy of the world'

India supplies almost 20 per cent of the medicines consumed by the world. Every third tablet in the US market is from India

USFDA removes partial lifting of import on API facility at Ratlam: Ipca Lab

USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa

Covid-19 updates: FDA's remark on HCQ, race for Covid-19 vaccine and more

After "positive preliminary" results of phase I and II clinical trials, the vaccine-maker is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study

US Health Secy tells docs to prescribe HCQ as FDA withdraws use in Covid-19

During a White House media appearance with President Donald Trump, Azar asserted that HCQ was approved in the United States

US FDA ends emergency use of hydroxychloroquine to treat Covid-19

The decision on the so-called 'wonder drug' as touted by the US President Donald Trump is taken in the wake of recent clinical trials

Aurobindo's US manufacturing facility gets inspectional observations

The US drug regulator inspected the plant from January 13 to February 12,2020 and issued a letter to the company to this effect while classifying the inspection as 'Official Action Indicated'

Toward a coherent strategy for Covid-19

Having a strategy is essential. But equally important is that the strategy accurately describe the economic problem at hand

Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said