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.
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.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
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 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.
Hyderabad-based bulk drug major Aurobindo Pharma is looking at acquiring a $100 million European company to launch its operations in the continent.
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).
The focus of the company would be to develop its capability across segments of injectables, vaccines, biosimilars, inhalation and APIs to drive growth.
Both the units were under the scanner of FDA since 2011.
The company on Wednesday said P V Ramprasad Reddy would resign as executive chairman, while Nithyananda would also step down from his post.
The company's revenues are seen to cross $1 billion in three years time
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 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.
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.
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.
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 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.
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.
Atishi alleged that the BJP received "proceeds of crime" in its bank accounts
"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.
A sharp rise can be attributed to the significant changes in India's share buyback tax regime, which will come into effect from October 1, 2024.
A reading of the reports suggests that there is no standard practice for reporting political contributions and it is left to the company's discretion to report them as they find fit.
The agency made the disclosure in a chargesheet filed by it on May 10 against former Telangana chief minister and Bharat Rashtra Samithi leader K Chandrashekar Rao's MLC daughter K Kavitha and four others.
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.
The Delhi high court on Tuesday rebuked Chief Minister Arvind Kejriwal for 'casting aspersions' on the judicial process with his claim about an approver in the money laundering case against him making donations to the Bharatiya Janata Party through electoral bonds, saying the law relating to approvers was over 100 years old and not enacted to falsely implicate the Aam Aadmi Party leader.
Senior advocate Prashant Bhushan, who appeared for the petitioners in the court, said at least 30 shell companies purchased electoral bonds worth over Rs 143 crore.
Benoy Babu of Pernod Ricard and Sharath Reddy of Aurobindo Pharma have been arrested under sections of the PMLA.
Reddy, who was an accused in a money-laundering case linked to the alleged liquor scam in Delhi, had turned an approver in the case that is being probed by the Enforcement Directorate (ED). The CBI is yet to file a chargesheet against him.
The opposition's Indian National Developmental Inclusive Alliance (INDIA) will hold a 'maha rally' at Delhi's Ramlila Maidan on March 31 to safeguard the country's interests and democracy, Aam Aadmi Party leader Gopal Rai said on Sunday.
Bharat Rashtra Samiti leader K Kavitha is expected to be produced before a special Prevention of Money Laundering Act (PMLA) court by the Enforcement Directorate in New Delhi on Saturday for obtaining her remand for custodial interrogation in the money laundering case linked to alleged irregularities in the scrapped Delhi excise policy 2021-22, officials said.
The index is currently trading at 149 per cent of its historical P/B valuation, surpassing its previous peak of 125 per cent made in 2020-21.
Statements of five 'Angadiya' firm operators have also been recorded by the ED to establish the "money trail" of this alleged Rs 45 crore bribe amount.
'The BJP was supporting him from behind in order to bring down the Congress government.'
The Enforcement Directorate has summoned Telangana Chief Minister K Chandrashekar Rao's daughter K Kavitha in connection with a money laundering case linked to alleged irregularities in the Delhi excise policy, officials said on Wednesday.
BRS leader and former Telangana minister Vemula Prashanth Reddy claimed that Kavitha was taken to Delhi on a flight at 8.45 pm.
In a massive setback to Delhi Chief Minister Arvind Kejriwal, the Delhi high court on Tuesday dismissed his petition challenging his arrest in a money laundering case stemming from the alleged excise scam, saying there was no contravention of legal provisions.
The Enforcement Directorate on Friday arrested Bharat Rashtra Samiti leader K Kavitha after an hours-long raid at her premises in Hyderabad and brought her to Delhi for questioning in a money laundering case linked to the now-scrapped Delhi excise policy, agency sources said.
An acute drug shortage in the US and stable pricing along with product launches are likely to boost revenues of India's pharmaceutical companies during the first quarter of this financial year, analysts said. Most brokerages estimate a top line growth of around 14-15 per cent, with earnings before interest, taxes, depreciation, and amortisation (Ebitda) growth of 24-30 per cent for Q1 of FY24. Hospitals are, however, likely to report lower occupancy rates, and diagnostics companies may witness an impact from delayed monsoon.
© 2026 Rediff.com - Investor Information - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances