The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
The USTR has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favour local drug makers.
Companies such as Cadila Healthcare, Lupin, and Natco, which sell generic versions of flu medication in the US market, are likely to benefit.
The firm, however, said the anti-cholesterol tablets meant for the US market will be produced at its Mohali SEZ plant in Punjab and not at the three units banned by the US health regulator.
Daiichi Sankyo had entered into a licensing agreement with Sanofi-Aventis in 1993 for marketing levofloxacin (Tavanic) in Europe, Africa, South America and in some countries in Asia. Sanofi-Aventis is currently selling the drug in more than 90 countries under the brand 'Tavanic'.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing Indian drugs market.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
10 non-bank and non-finance stocks from the BSE500 Index universe that offer an optimal blend of low valuation, reasonably robust revenue and earnings growth in recent quarters, a strong balance sheet, and most importantly, positive cash flow from their operations.
One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.
The year also witnessed Mumbai-based Sun Pharmaceutical continue the tussle for taking over Israeli drug firm Taro, while MNCs struck alliances with Indian companies to capitalise on generics expertise in New Delhi.
The National Pharmaceutical Pricing Authority, which regulates the prices of medicines, has identified around 70 anti-cancer drugs, including anti-breast cancer medication Letrozole and anti-blood cancer drug Imatinib, for detailed price analysis.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
The US-based Dawn Alliance group is planning to set up a United States Food and Drug Administration-approved generic drug manufacturing facility in India.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
The drug is licensed to Ranbaxy Laboratories from Cipher Pharmaceuticals Inc of Mississauga, Ontario. It is currently protected by two issued patents listed in the FDA's approved drug products list, which expire in September 2021, the company said in a statement.
GVK Biosciences is the latest Indian firm to come under international scrutiny over quality issues.
Taro, which has been warding off a takeover bid by the Indian firm ever since their proposed $454 million merger deal was called off in 2008, warned the shareholders that if Sun was successful in its bid, then the Israeli firm may be facing the same fate as that of Caraco Pharmaceutical Labs.
The department of pharmaceuticals turned down a review petition by drugmaker Cipla against a price fixation order by the National Pharmaceutical Pricing Authority, slashing the price of Dytor Plus, a medicine for kidney and heart ailments.
The recent pullout by ICICI Venture and Citigroup Venture from a three-year-old drug discovery partnership with Dr Reddy's Laboratories points to angel investors' growing aversion to risk in pharma and biotech firms, say experts.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
It brought more drugs under control, cracked foreign firms' patents and introduced new regulations when MNCs acquire Indian cos.
'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'
Both the companies intend to integrate their business operations in Thailand to leverage and maximise the synergies of hybrid business model, which is expected to commence business on April 1, 2013, Ranbaxy said in a statement on Wednesday.
Sun generates 41 per cent of its annual revenues from the US market, a record of sorts among Indian drug firms. The company is bullish on its US prospects and expects 25 per cent growth in the country this year, higher than the 18-20 per cent growth projection it has given for other markets including India. The US is the world's largest market for medicines and accounts for nearly 50 per cent of the $780 billion global medicine sales.
The Wall Street Journal has reported that the SEC has contacted many investment banks whose analysts cover generic drug-maker Mylan, asking about a meeting the company hosted last September with those analysts and a group of investors.
Pharmaceutical firm Strides Arcolab on Friday said it has launched its anti-swine flu drug 'Starflu'.
New drug discovery and contract research have taken a back seat as global drug majors have slowed down their research and development offshoring to India.
The apex court, which quashed the criminal proceedings pending at a Chennai court against two people, said law is meant to exist as a shield to protect the innocent rather than being used as a sword to threaten them.
The drug maker will lose some incentives if its membership is suspended, sources in Pharmexcil said.
Leading Indian drug firm Ranbaxy has launched court battles in Britain and the US against the American pharmaceutical giant Pfizer for the rights to produce the cholesterol drug atorvastatin at a cheaper price.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
There is a perception getting built inside the government that big technology companies -- a common term used for firms like Facebook, Google, Twitter, Amazon and the like - are becoming very powerful and present multiple threats to entire nations and their citizens today. The digital ecosystem is replete with CSAM (child sexual abuse material), fake news, drug trade, radicalisation, trolling among other social vices. Given the network effect that these platforms have, it is important to ensure that these platforms are not misused.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
Israeli drug firm Taro Pharmaceuticals has filed a law suit in a US district court against Mumbai-based Sun Pharmaceutical Industries alleging violation of non-disclosure agreement and misleading shareholders.
The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.
The transaction, to be followed up by an open offer, puts the entire deal value between $3.4 billion and $4.6 billion.
As fear grips the world, demand for protective gear used by health care professionals and citizens is on a rise. And, supply disruption from China has opened a window of opportunities for Indian medical device makers.
Earlier in February, Daiichi Sankyo had announced it would launch an open offer for Zenotech to acquire 68.85 lakh shares or a 20 per cent stake. Daiichi had said it would pay up to Rs 78.23 crore (Rs 782.3 million), at Rs 113.62 a share, to Zenotech shareholders for the stake in the open offer, which was scheduled to begin on July 15 and close on August 3.
India's trade ties with Israel have only strengthened in the years after 2019. The total value of trade rose to $10.5 billion on a rolling four-quarter basis in June 2023 from $5.5 billion in the same month in 2019, shows a Business Standard analysis of data from the Centre for Monitoring Indian Economy (CMIE). A rolling four-quarter number provides a comparable figure across different time periods.
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