The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
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.
Prosecutors unveiled charges against Valvani alleging he fraudulently made $25 million by getting advance information about US Food and Drug Administration approvals of generic drug applications
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.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
The company's US-based subsidiary Lupin Pharmaceuticals Inc has launched its generic Rabeprazole Sodium delayed-release tablets, 20 mg in the American market after having received approval to market it from the US Food and Drug Administration, according to a statement by Lupin.
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.
Patanjali's packet milk to be lower than competitor brands by Rs 2 a litre
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
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.
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.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
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.
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.
The estranged Indian partner of McDonald's, Vikram Bakshi, on Thursday offered buying out the US food major's stake in their joint venture Connaught Plaza Restaurants.
Sayre Therapeutics aims for a spot among top 5 players in oncology.
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.
Bakshi had moved the application under Section 9 of the Conciliation and Arbitration Act, dealing with foreign arbitration and foreign tribunals.
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.
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.
The company's market value rose by Rs 1,684.87 crore.
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
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.
Kraft, the American food giant, said in a statement on Tuesday that Cadbury's board had unanimously endorsed the offer worth 840 pence per share. The revised offer is for 500 pence cash and 0.1874 new Kraft shares for each Cadbury share.
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.
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.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
Differences between Bakshi, his wife and McDonald's India emerged in mid-2013.
In yet another twist to the ongoing tussle for Cadbury, US-based Kraft Foods is looking at raising the cash component of its hostile takeover bid for the British confectioner.
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.
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.
Sun Pharma and Dr Reddy's top list in terms of those who face most class-action litigation
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
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