Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
US drug regulator's fiat on Mohali factory, after strictures on the two other major Indian units, has numerous negative implications.
This generic Doxorubicin HCl Liposome injection USP, 2 mg/ml is therapeutically equivalent to Doxil Liposome Injection, 2 mg/ml of Janssen Research and Development, LLC.
US experts were pondering on the safety of food imported into US from developing countries. In lieu of this thought process, a new trend has emerged in America of preferring locally produced food. This trend is affecting Wal Mart and Whole Foods too. It has been observed that when food travels far, the local community are the least benefitted out of the exports. But the trend to grow more locally will seriously affect nations that depend largely on agricultural exports.
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.
The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.
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.
After recovering from issues such as defaults on foreign currency convertible bonds and piling debts, pharmaceutical major Wockhardt has been on the slow lane through the last six months, following warnings from global regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
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.
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.
The number of dollar billionaires in India has risen to 55 this year from 46 last year.
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
The high court had given the company six weeks for retesting.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
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.
Wockhardt might be headed for another crisis, as it has come under the scanner of US health regulator.
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
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
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.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
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.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
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 health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
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.
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