Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.
The company said it is launching the product immediately
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.
Wockhardt's US subsidiary, Wockhardt USA, has launched Ondansetron injection in the United States on December 26.
Approval was given by the United States Food and Drug Administration for an investigational new drug application for ZYGK1, Cadila Healthcare said in a filing to the Bombay Stock Exchange.
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.
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.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.\n\n
The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.
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 Trade Representative noted that India's average applied tariff rate stood at 17% per cent, the highest of any major world economy.
The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.
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.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
Ranbaxy Laboratories on Monday said it has received final approval from the United States Food and Drugs Administration to manufacture and market Amoxicillin and Clavulnate Potassium tablets, a generic version of GlaxoSmithkline's Augmentin.
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets
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 Laboratories on Friday said it had received the United States Food and Drug Administration approval to manufacture and market Metformin HCL oral solution, a drug used by the diabetic patients.
Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.
'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.'
Dr Reddy's Laboratories has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Levetiracetam tablets, 250, 500 and 750 mg.
Wockhardt Ltd said on Thursday it has received approval from USFDA for marketing antibiotic, Clarithromycin tablets, in the US market.
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.
'It is not just the US and European opportunity, but it is a huge global opportunity.'
The FDA has stepped up its efforts to ensure drug safety in recent months.
Wockhardt has received United States Food & Drug Administration approval to market Zonisamide capsules.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
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.
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