Company had earlier received an import alert in February this year from the US Food and Drug Administration.
Hyderabad-based bulk drug major Aurobindo Pharma is looking at acquiring a $100 million European company to launch its operations in the continent.
The company has received the tentative approval from the US Food & Drug Administration to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg, a statement by Aurobindo Pharma said.
Since the start of this financial year (FY24), the stock of Aurobindo Pharma has been one of the top pharma gainers, enhancing investor wealth by over 68 per cent, with a third of those gains coming in the last three months. The stock is riding on multiple triggers given its investments in the production-linked incentive or PLI scheme, biosimilars, injectables and vaccines, which should drive revenues and profits over the medium term. Better than expected performance after the June quarter results led to a revision of earnings estimates for FY24 and FY25.
Both the units were under the scanner of FDA since 2011.
The company's revenues are seen to cross $1 billion in three years time
Aurobindo Pharma on Thursday said it had received US FDA approval for anti-retroviral Lamivudine, thus enabling it to participate in the president's emergency plan for AIDS relief), a US government initiative.
The focus of the company would be to develop its capability across segments of injectables, vaccines, biosimilars, inhalation and APIs to drive growth.
The company on Wednesday said P V Ramprasad Reddy would resign as executive chairman, while Nithyananda would also step down from his post.
Aurobindo Pharma Ltd has posted a net profit of Rs 211.50 million for the quarter ended December 31, 2002 as compared to Rs 201.00 million in the quarter ended December 31, 2001.
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.
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).
Concerns over weakening demand for Indian pharmaceutical (pharma) drugs in the US - their largest export market - have weighed heavily on investor sentiment this year. While the Nifty 50 has gained 6.02 per cent year - to - date (as on September 15), the Nifty Pharma index has declined 5.18 per cent, National Stock Exchange data shows.
The US Food and Drug Administration's (USFDA)'s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars - lower-priced, near-replicas of complex biologic medicines - could significantly benefit Indian biotech companies.
The tailwind of low price erosion in the US generics market, seen by domestic pharmaceutical companies in calendar year 2023 (CY23), may be reversing slowly, caution analysts. According to the latest data from US-based Centers for Medicare and Medicaid Services (CMMS), price erosion in calendar year 2024 (CY24) on a year-to-date (YTD) basis stood at a high of 15 per cent in the oral solid dosage (OSD) segment compared to a low of 1 per cent in CY23. This erosion, according to a report by Antique Stock Broking, was the highest in the last three years.
In its first acquisition in Europe, Aurobindo Pharma Ltd today said it has acquired UK-based Milpharm Ltd, in an all cash deal, from Whyte Group and Iracot Ltd.
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.
Indian drugmakers supply 47 per cent of the generic medicine requirements in the US, and tariffs would have increased prices in the US domestic market for patients, who are already dealing with drug shortages.
Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.
Benoy Babu of Pernod Ricard and Sharath Reddy of Aurobindo Pharma have been arrested under sections of the PMLA.
Hyderabad-based pharma company Aurobindo Pharma, which has plans to emerge as a billion dollar company by 2009-10, is enhancing its presence in Europe by investing $100 million in phases. The company is likely to buy two pharma companies worth Euro 10 million each, open offices in 10 countries and establish a packaging, warehouse and manufacturing hub in Malta.
Import alert on unit-6 facility might be lifted by FDA by Sept.
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.
Aurobindo Pharma has received licences from Bristol Myers Squibb Co to market two anti-AIDS drugs in 49 countries.
Aurobindo Pharma has acquired business assets of the UK-based generic drug maker Milpharm.
US-based pharma giants Eli Lilly and company has filed a case against two Indian drug makers, Aurobindo Pharma and Lupin alleging infringement of patent of its anti-depressant drug Cymbalta.
Aurobindo Pharma Ltd on Monday said its Anti-retro viral products have been included in World Health Organisation's pre-qualification list.
Aurobindo Pharma Ltd on Monday said its product Nevirapine tablets 200 mg, has been included by World Health Organisation in its pre-qualification list.
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.
Billed as the largest private placement by any pharmaceutical company in India, Hyderabad-based Auribindo Pharma would be issuing 38 lakh preferential shares with a premium of Rs 594 per share to net Rs 229.52 crore.
Aurobindo Pharma Ltd on Tuesday said it has received tentative approval from the US FDA for its Sertraline
Aurobindo Pharma on Monday said it has received a tentative new drug approval from USFDA for its fixed dose combination product used for treating HIV-1 infection.
Better-than-expected financial results in Q3 due to higher revenue growth and margins in key markets fuel the rally
The rupee's appreciation of 6.4 per cent against the dollar and 12 per cent against the euro is likely to hurt the first-quarter performance of the pharmaceutical sector, indicate a results' preview by broking houses.
These include former drugs controller M Venkateshwarlu, Ranbaxy CMD Malvinder Mohan Singh, Ranjit Shahani, India chief of Swiss pharma major Novartis AG, Ramaprasad Reddy, chairman Aurobindo Pharma and Rajesh Jain, joint managing director, Panacea Biotec.
Atishi alleged that the BJP received "proceeds of crime" in its bank accounts
The BSE Healthcare Index is up 19 per cent as compared to BSE Sensex returns of 11 per cent during this period. Nitin Agarwal of DAM Capital highlighted this trend in a report last month. "After a sustained period of underperformance over FY21-23, the BSE Healthcare Index has once again captured the spotlight. "The recent uptick in performance has been driven by hospitals and emerging green shoots in pharmaceutical exports, particularly to the US, along with sustaining momentum in domestic branded formulations," he said.
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