Lupin gets USFDA nod for Raltegravir tablets
Lupin announced that it has received an approval from US Food and Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg.
Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg, of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins Nagpur facility in India.
Raltegravir Tablets USP, 600 mg, are indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients and pediatric patients weighing at least 40 kg.
Raltegravir Tablets USP, 600 mg (Reference Listed Drug: Isentress HD), had estimated annual sales of $34 million in the U.S. for the 12 months ending March 2025, according to IQVIA.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The companys consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025.
The scrip fell 3.12% to end at Rs 2,006.40 on the BSE.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
17 minutes ago
- Time of India
HC asks MMRDA to deposit Rs 1,169 crore arbitral award in dispute with Reliance Infra
The Bombay High Court on Tuesday directed the Mumbai Metropolitan Region Development Authority (MMRDA) to deposit the arbitration award of Rs 1,169 crore with the court registry in connection with its dispute with the Mumbai Metro One Pvt Ltd ( MMOPL ), a subsidiary of Anil Ambani's Reliance Infrastructure . The MMRDA, a Maharashtra government agency, has moved the HC challenging two orders -- of August 2023 and February 2024 -- passed by a three-member tribunal in arbitration between MMOPL and MMRDA for various disputes including the cost of the metro project. The MMRDA, in an application, sought an interim stay to the arbitral award till the petition was heard and decided. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like B. Tech. Engineering Technology For Working Professionals. BITS Pilani WILP Apply Now Undo Justice Somasekhar Sundaresan on Tuesday refused to grant any interim relief without the amount being deposited. When parties agreed to submit themselves to arbitration and it culminated in an award, the money decree in the arbitral award is not something "written on water and irrelevant", said the judge. Live Events "Routinely granting a stay and that too without any deposit would run counter to the explicit legislative intervention that was made by Parliament to give teeth and relevance to arbitral awards," the HC said. The court further said no case was made out for an unconditional stay. If the MMRDA deposited the entire amount by July 15, then the execution of the award would be stayed pending final hearing and decision on the MMRDA's petition, it added. MMOPL, a joint venture of Reliance Infrastructure and MMRDA, operates Mumbai's first metro line on Versova -Andheri-Ghatkopar corridor. While Reliance Infrastructure holds 74 per cent stake, the rest is with MMRDA. The disputes between the two parties relate to the development, design, engineering, financing, procurement, construction, operation and maintenance of metro rail under a 2007 agreement. The metro rail project started with a delay of over two years. MMOPL claimed that the project costs increased from Rs 2,356 crore to Rs 4,321 crores, which the MMRDA contested. PTI
The Hindu
28 minutes ago
- The Hindu
Health Minister inaugurates Pay Ward at Pudukottai Govt Medical College Hospital
Health Minister Ma. Subramanian on Tuesday opened a Pay Ward constructed at the Pudukottai Government Medical College Hospital and inaugurated 20 medical buildings besides unveiling the foundation for 11 new medical buildings in the district. The Pay Ward with modern facilities has been established at a cost of ₹67.2 lakh. The new medical buildings that were inaugurated have been constructed at a cost of ₹6.95 crore, while ₹9.98 crore is to be spent for the construction of 11 others. Speaking to journalists at Pudukottai, the Health Minister said Pay Wards were being opened in Government Medical College Hospitals and Government Hospitals in various districts. The Pay Wards comprises various facilities with separate rooms which could also be utilised by middle and higher income groups to avail themselves of medical services. He said the State government had issued an order last week to establish a sewage treatment plant at a cost of ₹3.6 crore in the Pudukottai Government Medical College Hospital campus. The Minister participated in the third graduation reception ceremony held at the Pudukottai Government Medical College Hospital premises and distributed medals and certificates to 141 students. The Minister for Natural Resources S. Regupathy, Minister for Backward Classes Welfare Siva V. Meyyanathan, Pudukottai Collector M. Aruna and health department officials participated in the events. The Health Minister later unveiled the foundation of a critical care block at the Karur Government Medical College Hospital. The 50-bed critical care block is to be established at a cost of Rs. 23.75 crore.
&w=3840&q=100)
First Post
29 minutes ago
- First Post
SBI report finds India's household debt rise not a cause for concern
The Reserve Bank of India (RBI) sees the increase in household debt as sustainable, especially given two-thirds of the portfolio is made up of prime and above-credit-quality borrowers read more What happened India's household debt has been on the rise over the past three years. However, according to a report by the State Bank of India (SBI), this increase is not a cause for concern. The Reserve Bank of India (RBI) sees the increase in household debt as sustainable, especially given two-thirds of the portfolio is made up of prime and above-credit-quality borrowers. Tell me more - SBI reports that two-thirds of household debt in India is of prime and above credit quality, indicating strong repayment capacity. STORY CONTINUES BELOW THIS AD - The increase in debt is attributed to a higher number of borrowers, not excessive borrowing by existing borrowers. - Around 25% of household loans are for asset creation (homes, vehicles). - Another 30% are for productive purposes such as agriculture, business, and education. - 45% of loans (personal, credit card, and consumer durable) are used for consumption. - India's household debt stands at 42% of GDP, lower than the 49.1% average among other emerging market economies (EMEs). - The RBI's rate-easing cycle has led to a 100-basis-point cut in the repo rate, reducing interest rates on loans linked to external benchmarks. - Approximately 80% of retail and MSME loan portfolios are now linked to the External Benchmark Lending Rate (EBLR), leading to potential savings of Rs 50,000–60,000 for households. - The rate cut cycle is expected to continue for two years, helping further reduce household borrowing costs. - Last week, the RBI reduced the repo rate by 50 basis points to 5.5% and also cut the Cash Reserve Ratio (CRR) by 100 basis points in four tranches. The context Household debt is a key indicator of financial stability, and while rising debt can be risky, the structure and quality of India's household borrowing paint a relatively healthy picture. STORY CONTINUES BELOW THIS AD
