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.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
Pharmaceutical giant Ranbaxy on Monday said that it has received tentative approval from the US Food and Drug Administration to manufacture and market carvedilol tablets for treatment of cardiac disorders including hypertension.\n\n\n\n
The popular anti-impotence drug will be available in about 2,000 drugstores in major cities.
A slight variation of lactoferrin, known as talactoferrin alfa, helps fight lung cancer, according to research by Dr Atul Varadhachary, president and chief operating officer of the Houston-based Agennix.
Ranbaxy Pharmaceuticals Inc said on Tuesday it has received US Food and Drug Administration's approval for manufacturing and marketing cardiovascular drug -- Atenolol tablets in the US.
If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US FDA, it may face ban on many of its products.
The number of dollar billionaires in India has risen to 55 this year from 46 last year.
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.
Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
Wockhardt might be headed for another crisis, as it has come under the scanner of US health regulator.
The Maharashtra State Chemists and Druggists Association has called for a three-day token strike from October 16-18, to protest alleged harassment by the Food and Drugs Administration officials.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
The high court had given the company six weeks for retesting.
Nationalist Congress Party leader Ajit Pawar was given the finance and planning portfolio on Friday, nearly two weeks after he broke away from the original party and took oath as Maharashtra's deputy chief minister.
Indian drug major Ranbaxy Laboratories has got the US Food and Drug Administration nod for the manufacture and sale of Ofloxacin tablets.
Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
Wockhardt Ltd said on Tuesday it has got US Food and Drug Administration's approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen in the US market.
Ranbaxy Laboratories, in a release issued to the BSE on Thursday, said the US Food and Drug Administration has granted the company permission to market DisperMox (amoxicillin tablets for oral suspension - 200mg and 400mg).\n\n
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
Indian women may consider it sacred to adorn 'Sindoor' (vermilion) on their foreheads, but the United States government has warned against using a particular brand of this toxic 'red powder' due to high lead content.
Ranbaxy Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration to manufacture and market multiple dosages of anti-diabetes drug Glimepiride tablets.
A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.
The 2008 deal agreement contains provisions of arbitration to be held in that country.
The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.
All medicines that have USFDA approvals continue to be produced in the Poanta Sahib facility. The USFDA has not given any approval for new drugs as they have some concerns. We are addressing them, Malvinder Singh said.
Ranbaxy Laboratories has received tentative approval form the Food & Drug Administration USA for manufacturing and marketing Fluconazole tablets
Business of retail, food and beverages at duty-free shops in India was estimated to have a potential of $3.5 billion by 2021.
The Maharashtra government has capped the prices of N-95, double and triple layer masks for suppliers and private hospitals in the wake of the Covid-19 pandemic, state health minister Rajesh Tope has said.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
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