News for '-united-states-food-and-drug-administration'

Healthcare Funds: Caution Advised

Healthcare Funds: Caution Advised

Rediff.com12 Feb 2026

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.

'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.'

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.

J&J in talks with India for study of single-dose vaccine

J&J in talks with India for study of single-dose vaccine

Rediff.com9 Apr 2021

India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.

Molnupiravir not to be included in Covid treatment now

Molnupiravir not to be included in Covid treatment now

Rediff.com11 Jan 2022

The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.

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.

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.

Covovax nod to boost vaccination drive in India: SII

Covovax nod to boost vaccination drive in India: SII

Rediff.com28 Dec 2021

Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.

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

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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

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.

'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.

Govt in talks with Pfizer, J&J for supply of vaccines to India

Govt in talks with Pfizer, J&J for supply of vaccines to India

Rediff.com2 Jun 2021

The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.

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.

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.

Dr Reddy's files ANDA

Dr Reddy's files ANDA

Rediff.com22 Mar 2004

Dr Reddy's Laboratories has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Levetiracetam tablets, 250, 500 and 750 mg.

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.

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.

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Hetero's generic version of remdesivir to be sold @ Rs 5,400/vial

Rediff.com24 Jun 2020

The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.

Biden, wife to receive Pfizer COVID-19 vaccine on Monday

Biden, wife to receive Pfizer COVID-19 vaccine on Monday

Rediff.com19 Dec 2020

Biden previously told Jake Tapper of CNN that he would be "happy to" take the COVID-19 vaccine once US infectious disease expert Anthony Fauci said it was safe and he would get the injection in a public setting to prove it.

Serum to double Covid vaccine output in 2022

Serum to double Covid vaccine output in 2022

Rediff.com13 Jul 2021

SII would be scaling up its AstraZeneca-Oxford vaccine manufacturing capacity to 200 million doses a month from 100 million a month now, reports Sohini Das.

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.

'We put pressure on Biden admn over vaccines'

'We put pressure on Biden admn over vaccines'

Rediff.com13 May 2021

'Supplies should start moving to the Serum Institute without any impediments.'

In talks with India over 'expedited approval' of Covid vaccine: Pfizer

In talks with India over 'expedited approval' of Covid vaccine: Pfizer

Rediff.com3 May 2021

Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.

Cipla gets nod to import Moderna vaccine for emergency use in India

Cipla gets nod to import Moderna vaccine for emergency use in India

Rediff.com29 Jun 2021

India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.