In addition to the US drug regulator, Food and Drug Administration, and rival pharma majors that appear keen to launch litigation against Indian company Ranbaxy, a US citizen has joined the bandwagon by filing a case in the world's biggest drug market.
Chairman of the Department of Surgical Oncology at Lilavati Hospital in Mumbai, Dr P Jagannath shares interesting insights on how detecting cancer early on has helped many survive the disease.
Maggi has also come on the radar of US Food and Drug Administration.
Data also show that several other leading domestic pharma companies have recalled their products from the US
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.
Approval was given by the United States Food and Drug Administration for an investigational new drug application for ZYGK1, Cadila Healthcare said in a filing to the Bombay Stock Exchange.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
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.
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
But the newer entrants prove nimbler than the slowing pioneers.
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.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
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.
In fresh troubles for Nestle over safety standards of its famous Maggi noodle brand, the Uttrakhand Food Safety Department has collected samples of the 'two-minute' noodles from the company's Pantanagar plant and other places in the state.
Houston-based biotech firm awaits FDA approvals on its new drug for lung cancer treatment.
The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.
Children who previously had COVID-19 or the inflammatory condition MIS-C are not protected against the Omicron variant of coronavirus, according to a study which found vaccination, however, does afford protection.
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.
Hyderabad, Mar 28 (PTI) Dr Reddy's Laboratories Limited has launched Levocetirizine tablets (5mg), a bio-equivalent generic version of Xyzal tablets in the USA market, the company said on Monday.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
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.
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."
The EUA allows for Remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe condition.
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.
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.
United States Food and Drug Administration (USFDA) has given final approval to Glenmark Generics Inc for their abbreviated new drug application (ANDA) for Norgestimate and Ethinyl Estradiol tablets USP in the strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25/0.035 mg, the company said in a statement.
The Aam Aadmi Party on Sunday said Tihar authorities were 'lying' about specialist doctors examining Delhi Chief Minister Arvind Kejriwal, while his wife Sunita Kejriwal alleged that he was being denied insulin for diabetes as 'they want to kill' him.
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
Says former Ranbaxy owners concealed critical information on probe by US agencies.
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.
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.
China's API exports to India touched $3.3 billion last year, while Indian drugs struggled to post $500 million worth of exports to China.
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.
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.
The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.
The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.
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.
Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.
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