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.
'We recently launched Yesintek in the immunology space.'
Her grandfather Philip Spratt was accused by the British Raj in the Meerut Conspiracy Case in the late 1920s. Meet the lady in Aamir Khan's life.
US President-elect Donald Trump has nominated Indian-American scientist Jay Bhattacharya to lead the National Institutes of Health (NIH), the country's top health research and funding institutions. Bhattacharya, a professor of Health Policy at Stanford University, is known for his research on the health and well-being of vulnerable populations. Trump also nominated Jim O'Neill as the deputy secretary of Health and Human Services to work alongside Robert F. Kennedy Jr.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
After falling 17 per cent since the start of the year to its March lows, the stock of the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries, has clawed back nearly half of those losses. Recent acquisitions, a favourable court ruling in the case of the hair loss drug Leqselvi, an edge over peers owing to its specialty portfolio, and a diversified global presence have supported the recovery.
Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.
Ankleshwar plant is the third such facility to face action
US, the largest market for Indian shrimp exporters, is peeved over the use of banned antibiotics.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
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.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
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.
Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
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.
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.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
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.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
Industry insiders in India warn that any such move in the pharmaceutical sector could be counterproductive for the US as it may face increased drug shortages if tariffs are imposed on such imports.
A civic body in North Goa has banned the sale of the popular street food 'Gobi Manchurian' at roadside stalls in its jurisdiction after concerns were raised about the unhygienic conditions in which the dish was prepared, an official said on Tuesday.
Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.
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.
Start your day with walnuts, chia, fruit. You can't go wrong.
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.
Former Maharashtra minister Baba Siddique, who was shot dead in Mumbai, was a popular figure in Bollywood circles and had earned praise for supplying life-saving medicines to patients during the Covid pandemic.
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.
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.
