Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
Its Waluj manufacturing facility in Maharashtra failed to meet the good manufacturing norms prescribed by the UK drug regulator.
The introduction of e-pharmacy, to protect the interest of a handful of players, would hamper the interest of 800,000 chemists and 80 lakh workers and their families
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
The company did not comply to the 'good manufacturing practice' norms.
A widening probe by US authorities involving top drug companies following complaints of price fixing of generics was a point of worry for the participants, said analysts.
Dr Reddy's shrugged off recent volatility on Wednesday and moved tenaciously on filing new gernerics with the US FDA.
Lupin will fund the buy through $100 mn cash reserves and a bridge loan.
Apple on Wednesday launched the Series 4 of the Watch and three phones -- iPhone XS, XS Max and XR -- at the Steve Jobs Theater in Cupertino, California.
The names of two Indian-Americans -- Seema Verma and Bobby Jindal -- have emerged as possible candidates.
Sun Pharma and Dr Reddy's top list in terms of those who face most class-action litigation
Maggi banned in Delhi for 15 days.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
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.
'Nothing in this world is permanent. So also in business.' 'And more so in family businesses where family issues often influence business decisions,' point out S Subramanian and Nupur Pavan Bang.
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As per the media report, the US Food and Drug Administration is learnt to have issued a Form 483 to the company's manufacturing facility at Mohali a few months ago after finding deviations from norms during an inspection of the plant.
Viveka Kumar lists the factors you need to keep in mind.
Accenture -- considered as one of the top-most employers in India among the global technology services companies -- is believed to have over 150,000 workers in India, next to IBM.
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.
The state government had in the first week of June banned Maggi sale in the state after the product failed the food safety test.
'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'
A huge stock of Maggi noodles was destroyed by Nestle after the ban was imposed by the food regulators.
It hopes to turn around Ranbaxy within four years of closing the deal by improving efficiency and resolving all regulatory issues
Sun Pharma profit down 30% over compliance costs, lower sales.
Nestle now has less than two weeks to convince the regulator why product approval for its noodles should not be withdrawn
Pharma major Ranbaxy Laboratories has set aside Rs 257.4 crore (Rs 2.57 billion) towards the financial impact of a US ban on import of products made at its plant at Toansa.
IT, pharma and FMCG stocks are the top performers in 2013.
The company spokesperson expressed disappointment with the "unprecedented step of filing of a complaint before the NCDRC"
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
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The report comes at a time when the government is trying to clear pending FDI proposals, which include various planned investments in this sector.
While Reliance Retail did not comment, sources said the company will have to follow order, at least in Delhi.
According to Munjal, there is an opportunity for somebody who comes from a not for profit background in health care to do something.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
Amneal Pharmaceuticals is set to pip Sun Pharma as the fifth largest generics maker in the US, reports Sohini Das.
market, was today seized from an illegal drug manufacturing unit in Jalgaon district in north Maharashtra and six persons were arrested, Directorate of Revenue Intelligence officials said.
DRL launched four new products in North America during the previous quarter.
In India, thousands of lives are lost every year because of unavailability of organs
4 Ranbaxy facilities in India have been barred from exporting to US.
'India easily remains one among the more attractive large economies, with high growth and stable/improving macros, as a top investment destination.' 'We are looking pretty good.'
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