India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis. With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.
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.
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.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
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.
India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.
But the newer entrants prove nimbler than the slowing pioneers.
Teja is among the 12 personalities from the Telugu film industry summoned by the SIT.
Normalcy returned to the city, recently renamed as 'Chhatrapati Sambhajinagar', even as the government deployed five companies of the State Reserve Police Force as a precaution.
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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.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
The Maharashtra government has capped the prices of N-95, double and triple layer masks for suppliers and private hospitals in the wake of the Covid-19 pandemic, state health minister Rajesh Tope has said.
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.
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 yet another deadly attack on Indians and Indian-Americans in the United States in recent months, a 34-year-old trained classical dancer from India and a student of Washington University, was shot dead in St Louis, Missouri.
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.
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.
Houston-based biotech firm awaits FDA approvals on its new drug for lung cancer treatment.
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.
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.
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."
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
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.
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.
The source of the synthetic drugs was Asia, especially India and China.
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.
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.
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 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 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 central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
Drug major Ranbaxy on Wednesday said it has received approval from the Australian health regulator to market its antipsychotic drug Ozidal Risperidone in that country.
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.
Says former Ranbaxy owners concealed critical information on probe by US agencies.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
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 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.
The surprising part was that seven of his personal security officers were youngsters, who had joined his drug de-addiction centre for rehabilitation, the officials said, adding that during their stay there for treatment they had been imparted training.
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