USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
US accounts for a large part of revenue for top Indian pharma companies like Gland Pharma (54 percent), Dr Reddy's (53 per cent), and Aurobindo Pharma (48 per cent).
Movement in the equity market this week will be guided by a host of macroeconomic data announcements, global trends and trading activity of foreign investors, analysts said. Stocks markets concluded the last week on a subdued note, as investors grappled with global uncertainties.
The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
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.
Industry insiders in India warn that any such move in the pharmaceutical sector could be counterproductive for the US as it may face increased drug shortages if tariffs are imposed on such imports.
Analysts are expecting pharmaceutical companies to post sales growth of 10-11 per cent in the second quarter this financial year while the Ebitda (earnings before interest, tax, depreciation, and amortisation) margins are anticipated to improve by about 110 basis points. Ebitda improvement will be led by lower input costs because prices of active pharmaceutical ingredients (APIs) are 5-15 per cent lower year-on-year (Y-o-Y). Axis Capital said sales growth would be around 10 per cent, of which growth in the India market would be 11 per cent or so.
"Remember, the IT Department and the ED implement the Pradhan Mantri Hafta Vasuli Yojana. The State Bank of India implements the #ElectoralBondScam. And at the end of the day, all of these institutions report to the same person: the Finance Minister," Ramesh alleged.
The two leaders had a complex relationship yet formed a partnership and even after their parting of ways, the two admired each other in their efforts for India's freedom.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
In a reprieve for controversial United States historian Peter Heehs who faced deportation from India, the Union home ministry on Friday extended his visa by one more year with effect from April 15.
AstraZeneca on Wednesday announced that it had filed separate patent infringement actions in the United States District Court, Delaware, against seven generic drug manufacturers, which have submitted abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) seeking marketing authorisation for Crestor.
The announcement of Murmu's candidature by BJP president J P Nadda came a day after she celebrated her 64th birthday.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
Ajit Balakrishnan on how to arrest a worldwide decline.
In his letter, Singh hinted since the Central Public Works Department's tableau already featured Bose, West Bengal's float was not included for the parade, without saying it in so many words.
At 64, the woman who will be India's 15th president, taking over from Ram Nath Kovind, will also be the youngest and India's first President to be born after Independence.
Indian companies have made acquisitions of $1 billion so far in January
And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
'The TMC has become a private limited company.'
Kolkata-based business tycoon Sanjiv Goenka's RP-SG Group claimed the Lucknow franchise for a whopping Rs 7090 crore, while international equity investment firm CVC Capital won the bid for Ahmedabad with a Rs 5600 crore offer.
While acknowledging Shivaji's naval contributions, questions are being raised about the inadequate acknowledgement of Chola sea-power in southern Tamil Nadu, which dates back by a few centuries, explains N Sathiya Moorthy.
An astrologer told Ramesh Menon that he was increasingly having worried parents asking him about the future of their children who were showing serious behavioural changes like lack of tolerance towards others, shunning social interaction, and even violent behaviour. They were worried because they had never ever seen such traits in their children before the pandemic.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
Sanjeev Nayyar offers a roster of things to do to see the India of our dreams.
Here's the full text of President's Ram Nath Kovind's address to the joint sitting of both houses of Parliament on the first of Budget Session 2022.
Life in Telangana is likely to come to a standstill on Tuesday, thanks to the state government's Intensive Household Survey. Not just the state-owned public transport buses, even private vehicles, will remain off the roads.
Quite a few large- and mid-cap stocks are yet to recover from the note ban, pharma, banking and rural demand-based industries among laggards.
Top companies added employees at 3% CAGR from 2003-04 to 2013-14, while revenues grew at 18%.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
It will now take at least two more years to get a clarity on the priorities and policies of the leadership of the new state of Telangana.
Short-covering and the propping up of net asset values have potential to boost frontline as well as second-rung names next week
Saroj Kumar Rath, author of the newly-published book Fragile Frontiers: The Secret History of Mumbai Terror Attacks, speaks to Rediff.com's Vicky Nanjappa.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
Markets ended lower amid volatile trade with Sun Pharma leading the decline.
Ajit Mishra, Vice President, Research, Religare Broking, answers readers's queries on stocks they own or want to buy.
Bharati Dutt witnessed life-changing events that shaped India on the threshold of freedom. Her memories are an account of how ordinary Indians saw India change.
In a surprise announcement in April, Sun and Ranbaxy -- at that time owned by Japan's Daiichi -- declared an all-stock deal to create India's largest and world's fifth-largest drugmaker in an over $4 billion deal.
Markets in green tracking firm global cues.
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