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.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
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.
The US president said that he has sought help from Prime Minister Narendra Modi to allow the sale of Hydroxychloroquine tablets ordered by the US to treat the growing number of coronavirus patients in his country, hours after India banned the export of the anti-malarial drug.
After reports of contamination in cough syrups sent from the country, India is considering a system to test them before exporting. It is learnt that the Central Drugs Standard Control Organisation (CDSCO) has sent a proposal to the Union health ministry on this. The idea is to test the medicines at government labs before exporting.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
The company has received final approval from the US Food and Drug Administration for its Abacavir Sulfate Lamivudine, and Zidovudine Tablets, Lupin Ltd said in a statement.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
The FDA has stepped up its efforts to ensure drug safety in recent months.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
The BSE Healthcare Index is up 19 per cent as compared to BSE Sensex returns of 11 per cent during this period. Nitin Agarwal of DAM Capital highlighted this trend in a report last month. "After a sustained period of underperformance over FY21-23, the BSE Healthcare Index has once again captured the spotlight. "The recent uptick in performance has been driven by hospitals and emerging green shoots in pharmaceutical exports, particularly to the US, along with sustaining momentum in domestic branded formulations," he said.
The court had provided a conditional relief to Nestle India.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
The trouble for Nestle's Maggi started in Uttar Pradesh last month and has now spread nationwide. The Food and Drug Administration has directed all states on Wednesday to get sample of India's most popular instant noodles tested for high content of lead and mono-sodium glutamate, a taste enhancer.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
Dinesh Thakur is famous for exposing Ranbaxy safety problems
The fees for facility inspection of foreign companies have been reduced
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
'There is no reason why we should break this business up.'
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
Bolstered by an impressive performance in the global specialty business and outstanding results in the Indian market, Sun Pharmaceutical Industries, the largest pharmaceutical (pharma) company in the country, showcased a strong performance in the July-September quarter (second quarter, or Q2) of 2023-24 (FY24).
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