News for 'fda'

US FDA warns against side effects of malaria drug

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.

Quality Lapses Shut Down Drug Makers

Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.

India Inc holds breath for Trump's new tariffs to kick in

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.

Now, Hospira under US FDA's lens

Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy

Cloud over US FDA inspection

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.

Wockhardt gets import alert from US FDA

Ankleshwar plant is the third such facility to face action

Why US FDA is cracking down on India's shrimp shipments

US, the largest market for Indian shrimp exporters, is peeved over the use of banned antibiotics.

Ranbaxy sues US FDA for revoking drug approvals

FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte

FDA raises concern over US unit: Wockhardt

Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.

Pharma cos should learn to appreciate FDA norms: Experts

Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations

Recipe: Walnut Chia Smoothie Pot

Start your day with walnuts, chia, fruit. You can't go wrong.

US FDA India head quits; regulator goes for rejig

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.

Baba Siddique: Political veteran known for grand Iftar parties

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.

No more Gobi Manchurian at north Goa's roadside food stalls

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.

FDA warns India's Emcure Pharma, cites repeated data fudging at plant

It is one of 42 drug-making factories in India that the FDA has banned in recent years

Ranbaxy drugs cleared FDA test before import alert

FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.

FDA halts sale of Bisleri!

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.

FDA asks Wockhardt to conduct global assessment of its plants

The FDA Commissioner Margaret Hamburg is slated to travel to India soon.

Aurobindo gets FDA nod for drug

Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline

Standards violation: FDA seizes Caraco drugs

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.

Now, UP FDA finds lead in ITC's Yippee noodles

Uttar Pradesh Food and Drug Authority (FDA) says it has found excess lead in the Yippee noodles of domestic giant ITC.

US FDA conducts surprise inspection of Dr Reddy's Vizag plant

The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes

Drugmakers draw more FDA scrutiny as US imports rise

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.

Indian drug firms top FDA list

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.

US FDA tightens regulatory noose on Indian drug firms

Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter

FDA warns Wockhardt on quality issues

Nestle India did not opt for re-test, instead burnt Maggi: FDA

Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.

Adulterated Drugs On Decline Amid Crackdown

Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.

FDA warns Ranbaxy's American subsidiary

The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.

US FDA to set up Indian offices by '09

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.

Now, US FDA gets a call from Indian pharma companies

The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it

FDA finds contaminated drug ingredient at GSK Ireland plant

The FDA has stepped up its efforts to ensure drug safety in recent months.

Wockhardt hit by FDA alert on another plant

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.

Sun Pharma hit by FDA ban on Gujarat plant, shares fall

Recently, Ranbaxy and Wockhardt too were hauled up.

Mumbai hospitals await FDA guidance on Ranbaxy drugs

Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.

FDA hikes fee for drug approvals, cuts unit inspection charge

The fees for facility inspection of foreign companies have been reduced

Aurobindo Pharma gets US FDA nod for Lamivudine

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.

It's confirmed! McDonald's India uses authentic cheese

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.

After J&J, FDA puts Wipro on notice

The Maharashtra Food and Drug Adminstration has served a notice to Wipro for allegedly "misbranding and mislabelling" its baby oil.

Dead snake found in mid-day meal packet in Sangli

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.