Dr Reddy's Laboratories Ltd on Friday said it has received tentative approval from US Food and Drug Administration for amlodipine besylate tablets.
With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
Ranbaxy Laboratories has received US Food and Drug Authority approval for Benazepril Hydrochloride, a high blood pressure drug.
Sun Pharma Ltd has received tentative approval for cancer drug Ondansetron from US Food and Drug Administration.
Move follows a spate of international regulatory enforcements on Indian drug firms.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
It had posted net profit of Rs 125.75 crore (Rs 1.25 billion) during the January-March quarter of the previous fiscal, 2012-13.
The FDA issued the letter on October 15, and has given the company 15 days to respond.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.
Ranbaxy Laboratories on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.
Scientists have developed a new and more effective drug to help smokers quit the habit, which is known to reduce the life span of those addicted by about 10 years and is the single most important factor for heart attacks the world over.
Of the 30-share Sensex pack, 22 ended with losses while NTPC ended flat at Rs 127.30.
Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine Tablets in 150 mg strength, the company announced on Saturday.
Ranbaxy Laboratories Ltd on Tuesday launched its approved generic formulation of Clarithromycin immediate release tablets in the US market.
Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.
Hyderabad based Dr Reddy's Laboratories has received approval from the US Food and Drugs Administration for multiple strengths of anti-diabetes drug glimepiride tablets.
GlaxoSmithKline has filed a lawsuit in a United States court against Dr Reddy's Laboratories alleging infringement of patent rights of a generic version of 'Imitrex' drug, used for the treatment of migraine.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
American drug company Akorn Inc has signed a Letter of Intent with Indian pharmaceutical giant Cipla to develop and supply an oral anti-infective drug in the United States.
The US market for the drug is pegged at $1 billion. Cipla has been selling the product in the European market. It had won a similar case in the UK against GSK a couple of years ago.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
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.
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