Wockhardt might be headed for another crisis, as it has come under the scanner of US health regulator.
Many say trend could lead to concerns on manufacturing quality in Indian facilities.
A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
Last week, Sun's Israeli subsidiary, Taro Pharma, received the US Food and Drug Administration's approval for its New Drug Application to launch Topicort Topical Spray for the treatment of psoriasis.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
The 2008 deal agreement contains provisions of arbitration to be held in that country.
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products.
In the latest initiative, the US food giant has roped in popular Indian cartoon character Chhota Bheem to sell various items through its retail outlets in India.
CBD oil, found in marijuana, is gaining popularity for its pain-relieving properties. It's now legally available in India
In the last one month, Indian pharmaceutical company Lupin has won US Food and Drug Administration nod for three of its contraceptive pills, and has at least nine approvals pending with the regulator.
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
Through a Freedom of Information Act request, the Show '20/20' obtained lists of recent health violation records from the FDA, the agency in charge of inspecting airlines and their outside food caterers.
'I have a voice and must use it to do as much as I can.'
A popular energy drink, produced by a company founded by an Indian-American billionaire, has come under the scanner in the United States after reports of 13 deaths possibly linked to the energy shots.
Work to begin after that on corrective measures to meet US regulator's requirements.
Regulator says fee would enable it to quicken approval process.
USFDA has extended the timeline for granting tentative approval to generic drug applications filed under Para IV of its rules by 10 months.
Lupin will be launching the generic version of Yasmin, a brand of Bayer Healthcare.
In 2012, drugs worth $35 billion went off-patent in the US, while the market size of drugs which will see patent expiry in 2013 will halve to $17 billion.
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
Wockhardt said it is launching the product immediately in the US market.
Sources say FDA letter over product and not entire facility
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
Import alert on unit-6 facility might be lifted by FDA by Sept.
This move could cost $299 million a year for Indian pharma players.
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.
USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.
Ranbaxy has also agreed to relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications.
Both the units were under the scanner of FDA since 2011.
Bureaucratic insensitivity gave way to compassion with the state administration, police and passersby joining forces to help the stream of Indians fleeing Delhi.
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.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
The regulator has given the company 15 days to take corrective measures and report back to it.
Ankleshwar plant is the third such facility to face action
Around 81 per cent of the workers constitute the unorganised sector - devoid of any social security cover and outside the purview of a complex set of labour laws.
'I could not believe that the prime minister knew me.'
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.
The anti-depressant drug market in the US is primarily ruled by Effexor XR (Venlafaxine) of Wyeth (now owned by Pfizer).
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.
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