The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
The United Kingdom extracted USD 64.82 trillion from India over a century of colonialism between 1765 and 1900 and USD 33.8 trillion of this went to the richest 10 per cent -- enough money to carpet London in notes of 50 British pound almost four times over.
These drugs will be entering in their global Phase -3 clinical trials early next year.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
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.
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.
Flipkart, Amazon, too, under radar
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.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
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.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
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.
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.
'Someone posts a job on LinkedIn and there are a thousand resumes in an hour? This is not the America IT professionals are used to.' 'Once they lose their job, it's impossible to get a job.'
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.
Sources say FDA letter over product and not entire facility
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 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
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.
Move follows a spate of international regulatory enforcements on Indian drug firms.
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.
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
A United States court has sentenced an Indian oncologist and his wife for using unapproved chemotherapy medications at their cancer institute for three years.
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 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.
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.
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.
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 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
On Thursday, the bench, after perusing the plea copy, noted that Wankhede had approached the Central Administrative Tribunal, too, against the notices issued to him by the NCB.
Given Narendra Modi's trust in him, Praful Khoda Patel is unlikely to back down in Lakshadweep.
The protestors called the state's administrative measures "only partial victory" of their movement.
The company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
Hindus for America First, a newly created grassroots organisation, has announced it will endorse Republican presidential candidate Donald Trump and launch a campaign against Democratic nominee Vice President Kamala Harris in the key battleground states of Pennsylvania, Georgia and North Carolina.
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.
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