Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
In a major boost to Ranbaxy Laboratories' exports to developed countries, the United States has approved marketing of flecainide acetate tablets in the country.
Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.
The company's US-based subsidiary Lupin Pharmaceuticals Inc has launched its generic Rabeprazole Sodium delayed-release tablets, 20 mg in the American market after having received approval to market it from the US Food and Drug Administration, according to a statement by Lupin.
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products.
Ranbaxy Laboratories, in a release issued to the BSE on Thursday, said the US Food and Drug Administration has granted the company permission to market DisperMox (amoxicillin tablets for oral suspension - 200mg and 400mg).\n\n
The combined sales of the branded versions of the products in the US is about $3.5 billion.
Indian drugmaker Dr Reddy's Laboratories hopes to launch two-to-three generic products in the United States this year in a bid to increase its share of a lucrative market, its chief executive said.
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to market an oral suspension form of Warner Chilcott's Duricef antibiotic, the Bombay Stock Exchange
A record number of 2,129 of Americans died in one single day, the previous highest being 2,074 on April 10. New York has become the epicentre of the country's outbreak with 2,03,020 confirmed cases and 10,842 deaths so far.
Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US
The novel coronavirus has mutated before, and both companies say they've found that their vaccines worked against other variations of the virus.
The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das
The previous single-day record was on May 7 at 2,769 deaths.
If a retail investor wants exposure to a healthcare ETF, it should be a part of his satellite portfolio, suggests Sanjay Kumar Singh.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
After spending considerable time and energy in remediation efforts in the wake of the US Food and Drug Administration's warning letter on compliance issues, the company's leadership has finally set out to bring the house in order.
Guterres reiterated his call for a COVID-19 vaccine to be a global public good available to everywhere and particularly, available in Africa.
Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.
The company has not yet revealed details about the unexplained illness but has stopped trials while doctors find out if the illness was caused due to the vaccine or was a coincidence.
Calling COVID-19 pandemic and vaccines as one of the most important aspects of his discussions with top officials of the Biden administration, External Affairs Minister S Jaishankar has said the endeavour is to expand production of vaccines in India with assistance from the US.
Fund managers said investors remained positive on the pharma manufacturing activity in India, which further strengthened during the Covid-19 period, on account of restrictions imposed on pharma imports from China.
Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.
While sales in the domestic market declined 4.2 per cent during the April-July period, exports grew steadily at 9.5 per cent during the same period.
US, the largest market for Indian shrimp exporters, is peeved over the use of banned antibiotics.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
Soon after Trump revealed to the world that he has been taking the medicine, the White House doctor said the president is in good health.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
The vaccine arrives at a critical moment for the US. Hospitalisations due to COVID-19 hit record highs for the seventh day in a row on Saturday.
'I want to thank Prime Minister Modi of India for allowing us to have what we requested for the problem arose and he was terrific. We will remember it'
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
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