The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
India's pharmaceutical exports to Iran have been hit owing to depleting rupee reserves in the West Asian country because of India stopping the import of crude oil from it in 2019 following US sanctions. Pharmaceutical exports dropped 71.25 per cent in April-August this year over the same period last year. The data from the Pharmaceutical Exports Promotion Council (Pharmexcil) showed exports to Iran had declined 31.29 per cent in 2022-23 as against the previous financial year.
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
Flipkart, Amazon, too, under radar
'No retaliatory tariffs now. You can retaliate after a few months.' 'Today, there is no need to retaliate because it is a question of long term benefits.'
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
Move follows a spate of international regulatory enforcements on Indian drug firms.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
The tailwind of low price erosion in the US generics market, seen by domestic pharmaceutical companies in calendar year 2023 (CY23), may be reversing slowly, caution analysts. According to the latest data from US-based Centers for Medicare and Medicaid Services (CMMS), price erosion in calendar year 2024 (CY24) on a year-to-date (YTD) basis stood at a high of 15 per cent in the oral solid dosage (OSD) segment compared to a low of 1 per cent in CY23. This erosion, according to a report by Antique Stock Broking, was the highest in the last three years.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
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.
The UK Home Office has announced a crackdown on illegal working across the country, targeting restaurants, nail bars, convenience stores, and car washes. In January, Immigration Enforcement teams conducted record-breaking raids, arresting 609 individuals, a 73% increase from the previous year. The crackdown comes as the government introduces new legislation aimed at tackling criminal gangs that facilitate illegal immigration. The Home Office highlights the dangers of illegal migration and the exploitation of vulnerable individuals while emphasizing its commitment to safeguarding workers and removing foreign criminals.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
US President-elect Donald Trump has nominated Indian-American scientist Jay Bhattacharya to lead the National Institutes of Health (NIH), the country's top health research and funding institutions. Bhattacharya, a professor of Health Policy at Stanford University, is known for his research on the health and well-being of vulnerable populations. Trump also nominated Jim O'Neill as the deputy secretary of Health and Human Services to work alongside Robert F. Kennedy Jr.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
President-elect Donald Trump announced a slate of key Cabinet nominations, including tapping former Democratic presidential candidate Robert F. Kennedy Jr. as his Secretary of Health and Human Services and former Congressman Doug Collins of Georgia as Secretary for Veterans Affairs. Trump also named Jay Clayton as US Attorney for the Southern District of New York, Todd Blanche as Deputy Attorney General, and Dean John Sauer as Solicitor General of the United States.
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.
The Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.
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.
The TIME 100 AI list is an interesting assortment of titans. Indians make up about 20 per cent of the coveted list, which is pretty commendable, notes Sandeep Goyal.
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 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.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
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 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.
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.
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 court had provided a conditional relief to Nestle India.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
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
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.
