News for 'United States Food and Drug Administration'

US Senator warns against poor-quality drugs from India

US Senator warns against poor-quality drugs from India

Rediff.com17 Oct 2025

United States Senator Jim Banks has urged the Food and Drug Administration (FDA) to step up inspections of overseas pharmaceutical manufacturing facilities, expressing concern over poor-quality drugs being imported from countries like India and China.

Healthcare Funds: Caution Advised

Healthcare Funds: Caution Advised

Rediff.com7 days ago

Most first-time investors may be better served by diversified options such as flexicap or multi-cap funds, which already hold pharma and healthcare stocks.

Cough syrup deaths: No state follows pharma safety norms

Cough syrup deaths: No state follows pharma safety norms

Rediff.com10 Oct 2025

The Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.

Cough syrup deaths: Many states ban Coldrif; MP suspends officials

Cough syrup deaths: Many states ban Coldrif; MP suspends officials

Rediff.com7 Oct 2025

A special investigation team (SIT) has been formed in Madhya Pradesh to investigate the deaths of 14 children in Chhindwara, suspected to be linked to a toxic cough syrup. The investigation includes arrests, exhumations, and a ban on the implicated cough syrup.

Where The Deadly Cough Syrup Was Made

Where The Deadly Cough Syrup Was Made

Rediff.com18 Oct 2025

Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that's been locked up. The non-descript two-room building is a manufacturing unit of Sresan Pharmaceuticals, the pharma company made its Coldriff cough syrup that has allegedly killed 25 children in Madhya Pradesh.

Cough syrup kills 14 children in MP, doctor arrested

Cough syrup kills 14 children in MP, doctor arrested

Rediff.com5 Oct 2025

Police have arrested a doctor for alleged negligence and registered a case against the manufacturer of a 'toxic' cough syrup after the death of 14 children in Chhindwara due to suspected renal failure, officials said on Sunday.

Is this medicine harmful during pregnancy? Trump links it to autism

Is this medicine harmful during pregnancy? Trump links it to autism

Rediff.com23 Sep 2025

In contrast to Trump's strong warnings, the FDA's current position remains more measured. In a recent letter to physicians, the agency stated that "a causal relationship has not been established" between acetaminophen use during pregnancy and autism, and acknowledged the existence of "contrary studies in the scientific literature."

States Seek Centre's Help To Deal With Trump's Tariffs

States Seek Centre's Help To Deal With Trump's Tariffs

Rediff.com2 Sep 2025

State governments have requested the Centre for export incentives, lifting of import duty in the case of cotton for the textile sector and GST exemptions.

Adulterated Drugs On Decline Amid Crackdown

Adulterated Drugs On Decline Amid Crackdown

Rediff.com10 Oct 2024

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

Checks On Drug-Making Units Begins

Checks On Drug-Making Units Begins

Rediff.com29 Dec 2022

The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country

Lupin pills hit legal wall in United States

Lupin pills hit legal wall in United States

Rediff.com12 Oct 2009

Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.

Now, Ranbaxy AIDS drug under US lens

Now, Ranbaxy AIDS drug under US lens

Rediff.com22 Sep 2008

It is now probing the quality of AIDS medicines supplied by the company to developing countries under US government-funded programmes. Estimates suggest that Ranbaxy has received over $9 million from the programme so far. Ranbaxy had a turnover of $1.5 billion in 2007-08, of which a quarter came from US sales.

'Medicines are just one part of the solution'

'Medicines are just one part of the solution'

Rediff.com21 May 2025

'We are looking at what kind of products, diagnostics or other solutions we can offer to become a well-rounded player in a particular disease area globally.'

Wockhardt receives US nod for cardiac drug

Wockhardt receives US nod for cardiac drug

Rediff.com23 Jul 2010

Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.

Ranbaxy resumes drug exports to US after 4 years

Ranbaxy resumes drug exports to US after 4 years

Rediff.com2 Apr 2012

The firm, however, said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.

Cipla HIV drug gets USFDA nod

Cipla HIV drug gets USFDA nod

Rediff.com26 Jun 2006

Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.

Diabetes Drug Linked To Vision Loss?

Diabetes Drug Linked To Vision Loss?

Rediff.com16 Jul 2024

Study suggested that constant use of Semaglutide may be linked to development of a condition called non-arteritic ischemic optic neuropathy.

USFDA nod for Aurobindo's AIDS drug

USFDA nod for Aurobindo's AIDS drug

Rediff.com11 Jul 2005

The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.

US bans import of 30 generic drugs of Ranbaxy

US bans import of 30 generic drugs of Ranbaxy

Rediff.com17 Sep 2008

The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.

Ranbaxy gets US FDA nod for drug

Ranbaxy gets US FDA nod for drug

Rediff.com15 Mar 2004

Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.

Dawn Alliance to set up generic drug facility

Dawn Alliance to set up generic drug facility

Rediff.com2 Feb 2007

The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.

Mice, roaches found in food served on US airlines: FDA

Mice, roaches found in food served on US airlines: FDA

Rediff.com21 Nov 2012

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.

'US bio-terrorism law to hit Indian food exports'

'US bio-terrorism law to hit Indian food exports'

Rediff.com9 Apr 2004

The new US bio-terrorism law, which mandates prior registration of food suppliers with the USFDA, is likely to adversely affect the Indian food and marines exports, warns a leading non-government organisation EAN-India.

Sun Pharma Q4 profit down 19% at Rs 2,149.8 cr, revenue up 8%

Sun Pharma Q4 profit down 19% at Rs 2,149.8 cr, revenue up 8%

Rediff.com23 May 2025

India's largest drug maker Sun Pharmaceutical on Thursday posted a decline of 19 per cent year-on-year (Y-o-Y) for its consolidated net profit for the fourth quarter of the financial year 2025 (Q4FY25) at Rs 2,149.8 crore. Meanwhile, its revenue from operations rose by 8 per cent at Rs 12,958.8 crore.

Quality Lapses Shut Down Drug Makers

Quality Lapses Shut Down Drug Makers

Rediff.com28 Jun 2024

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

US: Indian couple sentenced for using unapproved cancer drugs

US: Indian couple sentenced for using unapproved cancer drugs

Rediff.com14 Jun 2014

A United States court has sentenced an Indian oncologist and his wife for using unapproved chemotherapy medications at their cancer institute for three years.

Dr Reddy's launch generic cancer drug in US market

Dr Reddy's launch generic cancer drug in US market

Rediff.com12 Jul 2013

The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.

US food regulator testing Maggi noodles after India recall

US food regulator testing Maggi noodles after India recall

Rediff.com11 Jun 2015

Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.

Are Indian drugs safe? US doctors worried over quality

Are Indian drugs safe? US doctors worried over quality

Rediff.com18 Mar 2014

Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.

Ranbaxy forged data, says US drug regulator

Ranbaxy forged data, says US drug regulator

Rediff.com26 Feb 2009

India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.

Ranbaxy shares jump on drug approval in US

Ranbaxy shares jump on drug approval in US

Rediff.com27 Jun 2014

Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.

Ranbaxy gets FDA nod for hypertension drug

Ranbaxy gets FDA nod for hypertension drug

Rediff.com26 Apr 2004

Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.

US approves first HIV-prevention drug amid protests

US approves first HIV-prevention drug amid protests

Rediff.com17 Jul 2012

For the first time, a once-a-day pill which reduces the chance of contracting HIV among high risk groups "significantly" has got green signal in the United States, where 1.2 million people are infected by the deadly disease.

Trump picks anti-vaccine activist as health secretary

Trump picks anti-vaccine activist as health secretary

Rediff.com15 Nov 2024

President-elect Donald Trump announced a slate of key Cabinet nominations, including tapping former Democratic presidential candidate Robert F. Kennedy Jr. as his Secretary of Health and Human Services and former Congressman Doug Collins of Georgia as Secretary for Veterans Affairs. Trump also named Jay Clayton as US Attorney for the Southern District of New York, Todd Blanche as Deputy Attorney General, and Dean John Sauer as Solicitor General of the United States.

Sterilisation botch-up: FDA seals drug unit in Raipur

Sterilisation botch-up: FDA seals drug unit in Raipur

Rediff.com13 Nov 2014

The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.

US Cong seeks details of Ranbaxy drug approvals

US Cong seeks details of Ranbaxy drug approvals

Rediff.com24 Jul 2008

Two United States senators have asked the US Food and Drug Administration (USFDA) to provide details of market approvals given to all medicines sold by India's largest drug-maker Ranbaxy in that country.

Alembic to expand bulk drugs business in US

Alembic to expand bulk drugs business in US

Rediff.com22 May 2003

Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.

Ranbaxy gets USFDA nod for generic Serzone

Ranbaxy gets USFDA nod for generic Serzone

Rediff.com28 Apr 2003

The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.

Lupin receives US FDA nod for drug

Lupin receives US FDA nod for drug

Rediff.com28 Jul 2003

Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.