Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
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.
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.
The FDA Maharashtra on Friday lodged an FIR against Snapdeal.
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.
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 company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
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.
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 drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
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.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
Sources say FDA letter over product and not entire facility
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.
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.
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 combined sales of the branded versions of the products in the US is about $3.5 billion.
These drugs will be entering in their global Phase -3 clinical trials early next year.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
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.
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 Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.
Flipkart, Amazon, too, under radar
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
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.
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.
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
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.
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 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 company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
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.
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.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
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