Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.
Sources say FDA letter over product and not entire facility
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
A drug developed by the Defence Research and Development Organisation (DRDO) may reverse the heart damage caused by a protein in the SARS-CoV-2 virus, a study conducted in fruit flies and mice has found.
These drugs will be entering in their global Phase -3 clinical trials early next year.
If the actress fails to respond to the notice within the stipulated time frame, a case could be registered against her, Food Security Officer Mahimanand Joshi said.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
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
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
"India is not only buying massive amounts of Russian Oil, they are then, for much of the Oil purchased, selling it on the Open Market for big profits," Trump said in a social media post on Monday.
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
Move follows a spate of international regulatory enforcements on Indian drug firms.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
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 Food Safety and Standards Authority of India (FSSAI) has commissioned a quality check on MDH and Everest products. This follows complaints that several popular spice mixes of the two leading brands contained traces of ethylene oxide more than the permissible levels, official sources said. This move by FSSAI comes after Hong Kong and Singapore recalled variants of the two masala majors' products in their countries.
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 US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
Around 7.4 per cent of Indians aged 60 and above are affected by dementia. This number is expected to rise from the current 8.8 million to 17 million by 2036, marking a 97 per cent increase.
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.
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.
'It is not just the US and European opportunity, but it is a huge global opportunity.'
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 company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
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.
The heightened global uncertainty due to the US "reciprocal tariffs" on India may cause near-term corrections and market turbulence, but the long-term outlook remains constructive, market experts said on Thursday. The US has announced 27 per cent reciprocal tariffs on India, citing high import duties imposed by New Delhi on American goods.
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
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.
'A long-term investor with a 4 to 5 year horizon could invest in this theme via SIPs.'
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 Manipur government has accused Mizoram Chief Minister Lalduhoma of stoking hatred and division through "unwarranted comments" and called on him to display "better statesmanship" by being a "good neighbour". In a statement, the Manipur government alleged that Lalduhoma's comments were part of a "greater agenda" to carve out a Kuki-Chin Christian nation from contiguous areas of Myanmar, India, and Bangladesh. It also warned against any attempt to "push" illegal Kuki-Chin immigrants from Mizoram into Manipur for land grabbing and the creation of a "Greater Mizoram." The Mizoram government could not be reached immediately for comment.
