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.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
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 FDA has stepped up its efforts to ensure drug safety in recent months.
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
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.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Dinesh Thakur is famous for exposing Ranbaxy safety problems
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
He had taken charge as the 25th director general of the Indian Coast Guard on July 19 last year.
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.
'Investors looking at the next 6-12 months can be certain that the Fed will maintain its easing cycle, and we expect the overall environment to be conducive for fixed income investments for portfolio diversification.'
Delhi Cabinet Minister Saurabh Bharadwaj Sunday alleged that Tihar authorities have now requested a diabetologist from All India Institute of Medical Sciences (AIIMS) in contradiction of their earlier stance of adequate medical facilities for diabetics being present in the prison.
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.
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.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
The Delhi minister also claimed that Kejriwal used to take 50 units of insulin daily before he was sent to jail.
'There is no reason why we should break this business up.'
Trump said countries such as Afghanistan, India, The Bahamas, Belize, Burma, Colombia, Costa Rica and the Dominican Republic among others are a major drug transit or illicit drug producing nations.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
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).
The Bombay high court on Thursday said the Union government's allocation of Amphotericin-B, a key drug used in the treatment of mucormycosis or black fungus, appeared to be irrational, and the supply to Maharashtra was not adequate considering the number of cases in the state.
FDA allows Teva to launch Nexium generic; Cipla, which supplies formulation, to gain
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 recent terror acts are a sign of our enemy's desperation, he said, in an apparent reference to Pakistan.
'In a complex situation a PM coming was not necessary'
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 fees for facility inspection of foreign companies have been reduced
Harris will appoint hundreds of extreme far-left judges to 'forcibly impose crazy San Francisco liberal values' on Americans nationwide, he alleged, invoking the spectre of San Francisco -- a liberal city long used as shorthand by conservatives eager to denigrate Democrats.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
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.
Embattled US President Joe Biden on Sunday announced that he will end his candidacy for re-election in 2024 and endorsed Vice President Kamala Harris as the Democratic Party's new nominee, saying "it is in the best interest of my party and the country".
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
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.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
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.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
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.
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
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