The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it
The FDA has stepped up its efforts to ensure drug safety in recent months.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
Recently, Ranbaxy and Wockhardt too were hauled up.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
The fees for facility inspection of foreign companies have been reduced
Aurobindo Pharma on Thursday said it had received US FDA approval for anti-retroviral Lamivudine, thus enabling it to participate in the president's emergency plan for AIDS relief), a US government initiative.
The Maharashtra Food and Drug Adminstration has served a notice to Wipro for allegedly "misbranding and mislabelling" its baby oil.
Westlife Foodworld, fast-food chain McDonald's operator in West and South India, on Tuesday said food safety regulator FSSAI has verified the cheese used by it and is now allowed to use the word cheese in the name of its products. Additionally, an independent NABL (National Accreditation Board for Testing and Calibration Laboratories) has also confirmed that Westlife Foodworld uses authentic cheese in its food preparation and not cheese analogues or substitutes, its managing director Saurabh Kalra said.
Biotech major Biocon will file an application with the US Federal Drug Administration to begin clinical trials for oral insulin, which, it says, would be the world's first insulin that could be consumed orally.
A tiny dead snake was allegedly found in a packet distributed under the mid-day meal scheme meant for children aged between six months and three years at an anganwadi or a government-run nursery school in western Maharashtra's Sangli district, prompting the authorities to launch a probe.
Retail chain Subhiksha feels it is being unfairly targeted by the Food and Drugs Administration (FDA) of Maharashtra in initiating enquiries and hygiene checks on grounds that it is selling repackaged goods. The company would present its case in a hearing scheduled on August 8.
Inspections only in domestic authorities' presence, visiting US drug regulator told
On her maiden visit to India, US Food and Drug Administrator Margaret A Hamburg has said recent lapses in quality by a handful of pharma companies has overshadowed the good things done by other Indian companies, who emphasise on quality products and practices.
Rising Indian driver Jaden R Pariat has been invited to the Ferrari Driver Academy (FDA) selection trials.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
A report was positive for the presence of two dead and one live insect, FDA Commissioner Uttam Khobargade said in Mumbai.
Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
In a shocker, the US Food and Drug Administration has discovered the presence of mice, ants and cockroaches in food served on airlines in the country.
In a dazzling showcase at Apple Park, Apple on Monday introduced its latest technological marvels, including the much-anticipated iPhone 16 lineup. The event, held at the newly inaugurated Observatory building, featured an array of exciting updates that promise to redefine the smartphone experience.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
'The focus for value creation will be on all business segments.'
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
'There is no reason why we should break this business up.'
Ramaswamy was a distant fourth with 7.7 per cent of the votes polled in the Iowa Caucus
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).
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
Analysts have turned cautious on Cipla, as the recently issued form 483 by the US FDA with eight observations to its Pithampur (Indore) plant is expected to delay the launch of the company's key generic - Advair - in the US. The Indore plant contributes around 5 per cent of Cipla's revenues, as per analysts' estimates. While the respiratory product, which is used to treat asthma, had cleared the pre-approval inspection of the regulator at the Indore unit; the final approval could be unlikely until the company clears the recent US FDA observations, analysts say.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
