USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
'There is not any negative connotation associated with it.'
Charging the multinational companies with making several drugs beyond the reach of the poor, visiting Commerce Minister Anand Sharma today asserted it is the Indian generics which have challenged such a "suffocating stranglehold" and made the medicines affordable.
Sarfira seems to be scene-to-scene copy of the original, which begs the question: Why re-do a film if there's nothing new to add, asks Mayur Sanap.
Regulator says fee would enable it to quicken approval process.
'Whichever company offers better incentives, the chemist would prefer it.'
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
'However, we have seen weakness in our active pharmaceutical ingredients business.'
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The drug that it would supply is called Olanzapine, used to treat schizophrenia and bipolar disorder.
Continued demand for generics from the US market will ensure stable outlook for Indian Generics Pharmaceuticals in 2011, global rating agency Fitch Ratings said on Monday.
India's biggest drug maker Ranbaxy Laboratories Ltd has put in its bid to acquire generic business of German pharmaceutical firm Merck.
As the Drugs Controller General of India (DCGI) is set to crack down on companies to ensure compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they welcome the regulator's mandate and that they are on track. They also view it as a positive step to ensure patient safety. Sheetal Arora, CEO of Mankind Pharmaceuticals, which has already adopted QR codes in 20 of their products, stated: "We strongly advocate for mandatory implementation of barcodes and QR codes on medicines as this initiative will not only protect patients but also strengthen the integrity of our healthcare system by reducing circulation of counterfeit drugs."
Mandatory prescription of generic names is not a complete solution. Rather, in the absence of a range of approaches, it could mean passing the choice of selecting a drug from a doctor to a pharmacist, says Chandrakant Lahariya.
Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA), the representative body of US-based drug firms, has said it does not support the seizure of legitimate generic medicines meant for developing country destinations.
GlaxoSmithKline Plc's anti-migraine drug brand, Imitrex, is turning out to be a good revenue earner for Indian generic companies.
Dr Reddy's Laboratories has succeeded in developing a copycat or generic version of Pfizer's Lipitor, the world's largest selling drug which has sales of over $10 billion.
The Supreme Court on Monday dismissed a plea filed by the West Bengal government challenging the Calcutta high court's order which directed a Central Bureau of Investigation (CBI) probe into the allegations of crimes against women and land grabbing in Sandeshkhali.
Dr Reddy's Laboratories (DRL) is set to acquire Haleon's global portfolio of consumer healthcare brands in the nicotine replacement therapy (NRT) category outside of the US. DRL will pay a total consideration of 500 million, including an upfront cash consideration of 458 million and contingent cash payments up to 42 million based on performances in CY25 and CY26. DRL will acquire the portfolio through the purchase of shares of Northstar Switzerland SARL, a Haleon group firm.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
Rajkummar Rao does the best with what he is given and he ably elevates the generic story-telling. Too bad that his performance remains the only takeaway from such an inspiring real-life story, notes Mayur Sanap.
The launch came after final approval from the US health regulator to manufacture the generic version of Lipitor at Ranbaxy's wholly owned Ohm Laboratories facility in New Brunswick, New Jersey, as well as market the product.
The US market for the drug is pegged at $1 billion. Cipla has been selling the product in the European market. It had won a similar case in the UK against GSK a couple of years ago.
Bots don't suffer from the same nervousness that real matches do. This makes every conversation with a bot almost flawless and smooth, alerts rediffGURU Ravi Mittal.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
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'Mankind's experience, sharpness, and execution will make it happen. We are not going for short-term gains.'
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
The Indian company that acquires Merck Generics, the multinational drug maker's generics (non-patented) business, up for sale, will be able to compete against the top global players
But the newer entrants prove nimbler than the slowing pioneers.
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The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.
Terming the racial attacks on Indian students in Australia as 'generic', former Australian wicketkeeper Adam Gilchrist has said that the country was safe for students.
This move could cost $299 million a year for Indian pharma players.
Is yet to decide about the partnership or acquisition route
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