Altaf Ahmed Lal, country head of the US Food and Drug Administration (US FDA) in India, has quit and so have a few other key officials at the American drug regulator's India office.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The Maharashtra Food and Drug Administration has directed Parle Exports, manufacturers of Bisleri bottled water, not to release the product in the market till further orders.
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
Uttar Pradesh Food and Drug Authority (FDA) says it has found excess lead in the Yippee noodles of domestic giant ITC.
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.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
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.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.
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.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Under fire from some United States senators for allegedly taking lenient positions in granting product approvals to generic companies from countries like India, the US FDA is planning to speed up its plans to set up offices in India by 2009. FDA, in its latest newsletter dated July 21, has said that the agency will set up offices in Mumbai and Delhi to intensify its monitoring efforts.
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.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
Rising Indian driver Jaden R Pariat has been invited to the Ferrari Driver Academy (FDA) selection trials.
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.
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.
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
'There is no reason why we should break this business up.'
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.
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.
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.
Ramaswamy was a distant fourth with 7.7 per cent of the votes polled in the Iowa Caucus
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