Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
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 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.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
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.
The Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.
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
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.
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 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.
Flipkart, Amazon, too, under radar
Rathod said the Maharashtra government had initiated an inquiry against 84 out of 108 manufacturers of cough syrups in the state.
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.
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.
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.
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 company claimed that its product is "three times better than remdesivir and that 'AAYUDH Advance starts where vaccines stop'."
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.
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.
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.
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.
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 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.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
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.
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.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
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 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.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
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