Lupin launches generic version of kidney disorder treatment drug in US
Pharma major
Lupin Ltd
on Tuesday said it has launched the generic version of Tolvaptan tablets used to slow kidney function decline in the
US market
, following the recent approval received from the country's health regulator. The company has launched Tolvaptan tablets of strengths 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg in the US, after receiving the approval from the
US Food and Drug Administration
(
USFDA
).
#Operation Sindoor
The damage done at Pak bases as India strikes to avenge Pahalgam
Why Pakistan pleaded to end hostilities
Kashmir's Pahalgam sparks Karachi's nightmare
"Lupin holds the exclusive first-to-file status for this product and will have 180-day
generic drug
exclusivity,"
Lupin
said in a statement.
Tolvaptan tablets are bioequivalent to Jynarque Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, of Otsuka Pharmaceutical Company, Ltd, and are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), it added.
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
She is Revealing Her Secret Strategy in Commodity Trading
TradeWise
Learn More
Undo
by Taboola
by Taboola
Lupin
CEO
Vinita Gupta
said the launch of Tolvaptan Tablets in the US will provide ADPKD patients with increased access to high-quality treatment options.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
News18
32 minutes ago
- News18
India Set to Approve ₹10,000 Crore Project For High-Tech Spy Planes
Last Updated: The high-level approval for the I-STAR project is expected during a key Defence Ministry meeting scheduled for the fourth week of June. Amid ongoing operations against Pakistan under Operation Sindoor, the Ministry of Defence is poised to consider a ₹10,000 crore proposal for acquiring three advanced spy aircraft. These Intelligence, Surveillance, Target Acquisition, and Reconnaissance (I-STAR) platforms are designed to provide the Indian Air Force with enhanced air-to-ground situational awareness, enabling precision strikes on enemy targets such as radar installations, air defence systems, and mobile units. According to defence officials cited by ANI, the high-level approval for the I-STAR project is expected during a key Defence Ministry meeting scheduled for the fourth week of June. Indigenous Systems on Foreign Aircraft The I-STAR initiative is being spearheaded by the Defence Research and Development Organisation (DRDO) and involves the procurement of three aircraft through an open tender process. International manufacturers including Boeing and Bombardier are being considered for the platform. However, the surveillance and targeting systems onboard will be fully indigenous—developed by DRDO's Centre for Airborne Systems (CABS). Officials confirmed that these systems have already been successfully developed and validated by CABS and now require integration with the selected aircraft, which will then be modified to suit ISTAR specifications. Strategic Significance The induction of ISTAR capabilities will place India among a select group of nations—including the United States, United Kingdom, and Israel—that possess such high-end surveillance and targeting technology. The system offers real-time, multi-spectral surveillance and the ability to detect, track, and monitor irregular forces, significantly enhancing India's dynamic and time-sensitive targeting capabilities. Operating from high altitudes and long stand-off ranges, ISTAR platforms will enable day-and-night intelligence gathering, target identification, and reconnaissance operations. The comprehensive system will comprise both airborne and ground-based segments, aimed at generating a common operational picture for Indian forces. This development is expected to play a crucial role in strengthening India's security apparatus by reducing the complexity and scale of undetected threats, while providing an edge in strategic operations across volatile regions. First Published:
Indian Express
an hour ago
- Indian Express
India's wind sector must innovate and secure, not just scale
Amid heightened Indo-Pak tensions, a Pakistani outlet claimed cyberattacks had knocked out 70 per cent of India's electricity. The false report exposed a very real anxiety: What happens when energy infrastructure becomes a frontline in cyber warfare? For years, the renewable energy sector has diligently optimised turbine efficiency, improved grid integration and focused on speedy deployment. These remain essential. However, an equally pressing threat looms quietly in the background: Cybersecurity and the pace of maximum value addition and localisation in manufacturing. Unlike finance or defence sectors, where digital safeguards have long been entrenched, robust cybersecurity measures are only now being introduced into India's renewable energy framework. And it's about time. A compromised SCADA (Supervisory Control and Data Acquisition) system or remote-access breach could disable a wind farm — or multiple sites — in mere seconds. As India pushes towards achieving 500 GW of non-fossil-based electric installed capacity by 2030, including an ambitious target of over 100 GW from wind, the true challenge goes beyond just scaling up. It lies in securing what we install and how it is manufactured. The proposed amendment requires all operational wind turbine data to be stored within Indian territory. Foreign entities will no longer be allowed to remotely access or control Indian wind farms, a clear attempt to eliminate vulnerabilities to external cyber threats. More importantly, Original Equipment Manufacturers (OEMs) will be required to establish R&D facilities in India, signalling a decisive shift from passive assembly to active domestic innovation. This aligns with NITI Aayog's 2024 roadmap, emphasising localisation of both hardware and control systems. Given the various global incidents where cyberattacks have crippled energy grids, India's push for digital self-reliance isn't just necessary — it's urgent. Mandating local R&D isn't just about job creation or investment; it's about creating wind turbine technology designed for India's grid, climate, and challenges. India — not China or Europe — must become the epicentre for wind turbine innovation and manufacturing. However, strong policy intent must translate into effective execution, and here the amendment stumbles. Firstly, there is a greater need to build capacity for enforcement. Without a concrete monitoring mechanism, these rules risk becoming paper mandates. Secondly, the amendment needs to articulate India-specific design adaptation clearly. Renewable energy projects here face extreme operating conditions — temperatures exceeding 45°C, saline coastal air, monsoon deluges, and erratic grid voltages. Yet, there is no mandate for in-country prototype testing or climate-resilience validation before inclusion in the RLMMs (Revised List of Models & Manufacturers). This oversight risks importing turbines built for European conditions that buckle under India's punishing climate. Third, the policy skirts the need for embedded systems security. Today, power converters used in wind turbines and solar inverters in solar projects are effectively software-defined assets. They depend on SCADA systems, PLCs, and firmware that may be compromised — often subtly and invisibly. Without mandatory audits of software stacks and hardware backdoors, especially from OEMs in adversarial jurisdictions, India's wind and solar assets remain vulnerable. To operate in India, vendors/OEMs must obtain certification and clearance from Indian authorities and adhere to Government of India (GOI) regulations. These regulations should include provisions for force majeure situations, where vendor/OEM-supplied equipment may fail to receive support and patches, potentially leading to significant security breaches and national security risks. This ensures that even in times of geopolitical uncertainty, India's energy infrastructure remains operable, supported, and secure. Additionally, existing regulatory frameworks — like the Central Electricity Authority's temperature thresholds or the National Institute of Wind Energy's certification protocols — are treated as optional references, not core requirements. This disconnect must be addressed if we want turbines that are not just 'Made in India' but truly Engineered for India. The writer is a Partner at Dalberg Advisors, where he leads climate-related projects in Asia Pacific and globally
Time of India
3 hours ago
- Time of India
General Electric Eager to Power India's 5th Gen Fighter Jet
Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Popular in Epaper US' General Electric (GE) will vie for the contract to make engines for the Indian Air Force 's fifth-generation stealth fighter or advanced medium combat aircraft , chairman and chief executive Larry Culp told ET in an said the aerospace major considers India a strategically important market for both the civil and defence aerospace businesses.'We are very interested,' he said. 'If you look at what we're doing with the Tejas with our 404 engines, we are right in the middle of probably what matters most in that regard. The US and India enjoy a very strong relationship. So we are here, we want to be supportive and are engaged so we possibly can be.'Last month, India announced a long-awaited plan to fast-track the development of an indigenous fifth-generation stealth fighter. The announcement came days after Operation Sindoor against of the most critical components—a high-thrust engine—will likely be developed through a joint venture with a foreign manufacturer. GE will face competition on this from rivals such as Safran and is also stepping up the delivery of jet engines to plane maker Hindustan Aeronautics (HAL) for the Tejas Mark-1A fighter, which has been much delayed. In March, GE delivered the first of 99 F-404 engines, around two years behind schedule.'That is our intent and we've communicated that to everyone,' Culp said. 'We are working with the suppliers to ramp their capability. We're making good progress. I just look at April and May of this year compared to where we were in the first quarter—we've seen a double-digit increase in the number of receipts.'IAF chief Air Chief Marshal AP Singh recently voiced concerns about delays in the procurement of critical military military programmes and commercial airline sales are increasingly being delayed due to the inability of manufacturers to ramp up production. Culp said that though multiple actions are being taken to lessen the impact, it will be a while before the problem is solved.'We are making a tremendous amount of progress not only in GE but across the industry,' he said. 'But when you look at the demand expectations that only increase every year, we're going to be talking about supply chain for a while. That's just the nature of the challenge where we are in a super cycle.'GE will also look to set up a maintenance, repair and overhaul (MRO) facility for civilian aircraft engines in India once the volume increases. 'I think that's more a matter of when, as opposed to if,' he said. 'We want to make sure we have the underlying volume in the marketplace that would support those investments.'GE has more than 1,400 engines operating in India, powering both narrow and wide body aircraft and an order book for around 2,500 more. 'The number is sufficient to say that India is a priority country for us,' Culp you look at what we're doing with the Tejas with 404 engines, we are right in the middle of probably what matters most... The US and India enjoy a very strong relationship. So we are here, we want to be supportive.
