India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
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.
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.
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.
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.
Data also show that several other leading domestic pharma companies have recalled their products from the US
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.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
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.
Work to begin after that on corrective measures to meet US regulator's requirements.
PPD Inc has acquired exclusive worldwide license to develop, manufacture and market Ranbaxy's cholesterol lowering novel statin.
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.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
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."
'There is no reason why we should break this business up.'
The respondents were from over 22 states with 85 percent of them being under 35 years while 61 percent were interns or postgraduate trainees.
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.
Tech Mahindra and United Spirits will replace them in the 50-share index of the National Stock Exchange with effect from March 28.
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.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
The high court had given the company six weeks for retesting.
India on Tuesday temporarily licensed the export of paracetamol and anti-malarial drug Hydroxychloroquine in appropriate quantities to some countries, which have been particularly badly affected by the coronavirus pandemic.
Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
US experts were pondering on the safety of food imported into US from developing countries. In lieu of this thought process, a new trend has emerged in America of preferring locally produced food. This trend is affecting Wal Mart and Whole Foods too. It has been observed that when food travels far, the local community are the least benefitted out of the exports. But the trend to grow more locally will seriously affect nations that depend largely on agricultural exports.
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
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.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
Business of retail, food and beverages at duty-free shops in India was estimated to have a potential of $3.5 billion by 2021.
Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Hydroxychloroquine has been identified by the US Food and Drug Administration as a possible treatment for the COVID-19 and it is being tested on more than 1,500 coronavirus patients in New York.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Dilip Shanghvi founded Sun Pharma in 1983.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
