The FDA has stepped up its efforts to ensure drug safety in recent months.
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
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 Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
The court had provided a conditional relief to Nestle India.
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
'There is no reason why we should break this business up.'
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
The trouble for Nestle's Maggi started in Uttar Pradesh last month and has now spread nationwide. The Food and Drug Administration has directed all states on Wednesday to get sample of India's most popular instant noodles tested for high content of lead and mono-sodium glutamate, a taste enhancer.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
Bolstered by an impressive performance in the global specialty business and outstanding results in the Indian market, Sun Pharmaceutical Industries, the largest pharmaceutical (pharma) company in the country, showcased a strong performance in the July-September quarter (second quarter, or Q2) of 2023-24 (FY24).
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.
Dinesh Thakur is famous for exposing Ranbaxy safety problems
The fees for facility inspection of foreign companies have been reduced
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
As marketing rights for off-patent drugs in the US become less exclusive, companies are scrambling for fresh strategies to make up for the revenue loss.
The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
An advocate on Wednesday approached the Supreme Court with a PIL seeking cancellation of the license granted to Ranbaxy Laboratories and for initiating probe against the pharma major for allegedly manufacturing and selling adulterated drugs.
The company did not comply to the 'good manufacturing practice' norms.
Maharashtra Chief Minister Uddhav Thackeray has handed over portfolios of nine rebel ministers, who are currently camping in Guwahati, to other ministers.
Singh says Japanese pharma giant's allegations false.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
The company was indicted for violations at one of its US facilities in 2009, even after Daiichi Sankyo took over as majority shareholder in 2008.
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.
India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.
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.
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