This move could cost $299 million a year for Indian pharma players.
Drug-maker Ranbaxy Laboratories on Wednesday said it has signed an agreement with the US health regulator to lift a ban on the import of drugs from certain manufacturing plants in India and will pay up to $500 million to settle a case lodged by the Department of Justice.
Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
Ranbaxy, its partners and Actavis have signed a non-exclusive agreement.
Both the units were under the scanner of FDA since 2011.
According to a report, the executives are T G Chandrashekhar, vice-president, global quality and analytical research, and Abha Pant, executive director for regulatory affairs.
Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.
Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.
Natco Pharma's anti-cancer drug, NRC-AN-019, has received 'Orphan Drug' designation from the US Food and Drug Administration (USFDA) for three indications - glioma (brain tumour), pancreatic cancer and chronic myelogenous leukemia.
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.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Drug maker Sun Pharmaceutical Industries on Thursday said it has received the US health regulator's nod for marketing a generic version of the Keppra injection, used for treating epilepsy, in the American market.
A three-member committee, comprising two officials from the Director of Factories and one pharma expert, will probe the gas leak at a production unit of Dr Reddy's Laboratories (DRL). The Director of Factories will appoint a pharma domain expert soon.
The company has received a tentative approval for the company's abbreviated new drug application for Eszopiclone tablets from the US Food and Drug Administration, Lupin said in a filing to the Bombay Stock Exchange.
Sun Pharmaceutical Industries and its subsidiary, Caraco Pharmaceutical Laboratories, have reached a settlement agreement with drugmaker Forest Laboratories and licensing partner H Lundbeck AS, over a pending patent infringement dispute over Forest's blockbuster antidepressant, Lexapro.
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
Drug-maker Ranbaxy Laboratories on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
Australian health regulator Therapeutic Goods Administration is investigating Indian pharma major Ranbaxy, following US allegations of the company falsifying data and test results of new drug applications, a media report says.
Since UK referendum outcome to exit European Union last Friday, 32 companies have hit record highs.
Ranbaxy has acceded to the request of Health Canada to quarantine drugs produced from its Paonta Sahib facility at Himachal Pradesh, North American country's newspapers reported, highlighting the trouble in store for the Japanese-controlled drug maker. Health Canada is a department of the government of Canada with responsibility for national public health.
US-based Abbott Laboratories has sued Sun Pharmaceutical Industries and Ranbaxy Laboratories in courts there for challenging the patents of its cholesterol-lowering drugs, Niaspan and TriCor, respectively, in separate infringement suits.
But the newer entrants prove nimbler than the slowing pioneers.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
Cephalon, a US-based drug maker, has filed a lawsuit against Lupin Ltd and its US subsidiary Lupin Pharmaceuticals for challenging the patents on its sleep disorder drug Nuvigil.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
This increase is despite the decreased growth of drug sales in the US - the world's largest market - which has seen a tightening of regulations and aggressive competition.
Sun Pharmaceutical Industries on Friday said that it has received the US Food and Drug Administration's nod to market a generic version of alprazolam, an anti-anxiety drug, in the US market.
The USFDA has accused Ranbaxy of falsifying data and test results of medicines. A Daiichi Sankyo statement said it takes the issue very seriously. 'Both Daiichi and Ranbaxy have formed a team to solve the issue. Ranbaxy will be responding to the FDA and will continue to cooperate with the agency.' Ranbaxy shares fell more than 18 per cent to Rs 169.85 today on the Bombay Stock Exchange, while Daiichi stock dropped about 10 per cent to yen 1,680 on the Tokyo Stock Exchange.
India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.
Ranbaxy's shares jumped almost 10 per cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban, which is still in place, that stops the US importing or purchasing the company's drugs. Daiichi Sankyo, the Japanese drugmaker, reiterated on Wednesday that it would stick to its June offer to buy Ranbaxy in spite of its recent troubles.
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.
Sanjeev Dani, senior vice-president and regional director, Asia and CIS, Ranbaxy, said, "We are pleased to partner with Sirtex. We shall work towards creating a productive relationship."
Despite the ongoing trouble India's largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world's largest drug market with added vigour.
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