News for 'United States Food and Drug Administration'

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.

'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.'

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.

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.

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.

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.

USFDA to set up office in India

USFDA to set up office in India

Rediff.com18 Nov 2008

The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.

Wockhardt gets USFDA nod for anti-depressant tablets

Wockhardt gets USFDA nod for anti-depressant tablets

Rediff.com3 Sep 2012

The company said it is launching the product immediately

A COVID-19 Vaccine Snapshot

A COVID-19 Vaccine Snapshot

Rediff.com28 Apr 2021

Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.

Dr Reddy's launch generic version of Xyzal in US

Dr Reddy's launch generic version of Xyzal in US

Rediff.com28 Mar 2011

Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.

Wockhardt launches Ondansetron in US

Wockhardt launches Ondansetron in US

Rediff.com28 Dec 2006

Wockhardt's US subsidiary, Wockhardt USA, has launched Ondansetron injection in the United States on December 26.

Post takeover, Sun Pharma to rebrand Ranbaxy drugs in the US

Post takeover, Sun Pharma to rebrand Ranbaxy drugs in the US

Rediff.com9 Apr 2014

Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments

A bitter pill for Aurobindo's sterile drug unit

A bitter pill for Aurobindo's sterile drug unit

Rediff.com25 Nov 2019

USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.

Cadila gets USFDA nod for new diabetes molecule

Cadila gets USFDA nod for new diabetes molecule

Rediff.com7 Apr 2011

Approval was given by the United States Food and Drug Administration for an investigational new drug application for ZYGK1, Cadila Healthcare said in a filing to the Bombay Stock Exchange.

Glenmark gets nod for oral contraceptive tablets

Glenmark gets nod for oral contraceptive tablets

Rediff.com20 Jun 2011

United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.

Sun Pharma settles litigation with Novartis over cancer drug

Sun Pharma settles litigation with Novartis over cancer drug

Rediff.com15 May 2014

One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.

Ranbaxy gets nod for Fluoxetine

Ranbaxy gets nod for Fluoxetine

Rediff.com15 Dec 2004

United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.\n\n

Natco challenges Gilead's patent on Tamiflu

Natco challenges Gilead's patent on Tamiflu

Rediff.com9 Feb 2011

The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.

US FDA warns against side effects of malaria drug

US FDA warns against side effects of malaria drug

Rediff.com25 Apr 2020

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.

Cadila gets tentative FDA nod

Cadila gets tentative FDA nod

Rediff.com15 Jun 2006

Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.

Why Daiichi is taking Malvinder Singh to court

Why Daiichi is taking Malvinder Singh to court

Rediff.com27 Nov 2013

The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.

It's a tough road ahead for pharma companies

It's a tough road ahead for pharma companies

Rediff.com29 May 2013

Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.

Ranbaxy gets FDA nod for Amoxicillin

Ranbaxy gets FDA nod for Amoxicillin

Rediff.com8 Dec 2003

Ranbaxy Laboratories on Monday said it has received final approval from the United States Food and Drugs Administration to manufacture and market Amoxicillin and Clavulnate Potassium tablets, a generic version of GlaxoSmithkline's Augmentin.

JB Chem files 1st ANDA, US FDA

JB Chem files 1st ANDA, US FDA

Rediff.com16 Jan 2003

JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.

Dr Reddy's launches generic Parkinson's disease tablets in US

Dr Reddy's launches generic Parkinson's disease tablets in US

Rediff.com7 Jun 2012

The tablets are bio equivalent generic version of GlaxoSmithKline's Requip XL tablets

CDSCO panel recommends anti-Covid pill Molnupiravir for emergency use

CDSCO panel recommends anti-Covid pill Molnupiravir for emergency use

Rediff.com28 Dec 2021

The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions

Ranbaxy gets FDA nod for Metformin

Ranbaxy gets FDA nod for Metformin

Rediff.com12 Sep 2003

Ranbaxy Laboratories on Friday said it had received the United States Food and Drug Administration approval to manufacture and market Metformin HCL oral solution, a drug used by the diabetic patients.

Dr Reddy's get FDA nod for Ciprofloxacin

Dr Reddy's get FDA nod for Ciprofloxacin

Rediff.com10 Jun 2004

Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.

Pfizer moves US court against Aurobindo, Dr Reddy's over cancer drug

Pfizer moves US court against Aurobindo, Dr Reddy's over cancer drug

Rediff.com17 Nov 2020

Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.

Trump warns India of retaliation if it doesn't allow export of drug

Trump warns India of retaliation if it doesn't allow export of drug

Rediff.com7 Apr 2020

The US president said that he has sought help from Prime Minister Narendra Modi to allow the sale of Hydroxychloroquine tablets ordered by the US to treat the growing number of coronavirus patients in his country, hours after India banned the export of the anti-malarial drug.