Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
Recently, Ranbaxy and Wockhardt too were hauled up.
PepsiCo CEO Indra Nooyi's efforts to promote equality of women in business goes way beyond designing a maternity deal, but when it comes to choosing the American President she says only the best will do regardless of gender or race.
In the longest losing streak of 2017, the BSE Sensex has lost 1,270 points, or 3.91 per cent. It fell to a three-month low of 31,154.03 on Wednesday.
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
Mumbai-based pharma major Lupin will invest over Rs 200 crore (Rs 2 billion) this year to create additional manufacturing capacities.
The Indian pharmaceutical companies are involved in patent litigations of a mere 40 drugs, out of the 135 known patent litigation drugs in the US. This is despite the claims by major Indian players such as Ranbaxy and Dr Reddy's at having secured over 20 first to file status abbreviated new drug applications with the US Food and Drug Administration.
Maggi has also come on the radar of US Food and Drug Administration.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
Shares of Ranbaxy Laboratories on Friday slumped as much as 20 per cent in the morning trade after the USFDA prohibited the company from producing and distributing drugs for the American market from its Toansa plant in Punjab.
The court also restrained RHC Holdings from operating its bank accounts except for payment of salaries and statutory dues till March 23, the next date of hearing.
RPG Life already has marketing tie-ups with Israel's drug major Teva for the EU market and with the US-based Apotex for the Canadian market.
Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.
The company did not comply to the 'good manufacturing practice' norms.
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.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
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, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
Eli Lilly and Company, the US-based multinational pharmaceutical major, has sued Sun Pharmaceuticals in the US, alleging the company infringed its patent on Gemzar, a blockbuster cancer drug.
In a setback to pharmaceutical major Ranbaxy Laboratories Ltd, the US drug regulator USFDA has directed the company to recall as many as 7.32 crore (73.2 million) Gabapentin tablets of 600 and 800 mg strengths.
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.
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The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
The $66 million (Rs 272.8 crore) Leiner Health Products is likely to sue DRL for the early divorce (the agreement has lasted only four years) from the alliance.
Broader market outperformed with the S&P BSE Midcap index adding 0.7%, while S&P BSE Smallcap index gained 0.6%.
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
Money managers have turned cautious about the technology space.
The case was earlier heard by a different vacation bench which had on June 10 asked Sharma to substantiate his 'unfounded allegations' that the Indian pharma major was allegedly manufacturing and selling adulterated medicines.
Lupin Ltd received marketing approval from the US Food and Drug Administration to market its Cefixime oral suspension drug in the US, Ranbaxy Laboratories has received approval to market two strengths of Cefprozil tablets and Cefprozil powder.
The FDA had imposed a ban on the company's Waluj plant in May.
Agents from the US Food and Drug Administration apparently locked down the US headquarters of the Indian pharmaceutical major as well.
These drugs will be entering in their global Phase -3 clinical trials early next year.
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
Ranbaxy Laboratories will soon join the select club of Indian pharmaceutical majors and have a share in the $76.6 million generics market for anti-infective Cefprozil tablets in the US.
Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform
The company has already received approval from the US Food & Drug Administration for marketing clarithromycin tablets.
The company has received final approval from the US Food and Drug Administration for its Abacavir Sulfate Lamivudine, and Zidovudine Tablets, Lupin Ltd said in a statement.
In April, Mumbai-based pharmaceutical company Wockhardt announced it had received five marketing approvals for its generic medicines, versions of those that have gone off patents, from the US Food and Drug Administration in five weeks.
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