One of India’s pharmaceutical companies with a strong global footprint, Lupin, has launched risperidone long-acting injectable with 180-day CGT exclusivity in the US. This is the first product from its proprietary long-acting injectable platform, PrecisionSphere.
The Indian origin pharma major, Lupin, has launched risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, as it has received approval from the US Food and Drug Administration (US FDA). This is Lupin’s first product using proprietary technology from PrecisionSphere, the long-acting injectable (LAI) platform developed by Lupin’s subsidiary Nanomi B.V. (Nanomi).
Nanomi’s LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary PrecisionSphere technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere technology by fostering collaborations with companies looking to extend their product lifecycles.
“The launch of risperidone marks a significant milestone, demonstrating Lupin’s expertise in delivering complex injectables to market, validating the capabilities of the PrecisionSphere LAI technology platform,” said Spiro Gavaris, President, U.S. Generics at Lupin.
Leveraging its in-house expertise and alliance management, the company is planning to expand patient access to advanced LAI treatments through its growing internal pipeline and by forming new global strategic collaborations with companies that could benefit from longer-acting formulations for their products.
Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Risperdal Consta Long-Acting Injection. It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. RLD Risperdal Consta has estimated sales of $187 million combined for 25 mg, 37.5 mg and 50 mg in the US.
Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (API). The company has a presence in over 100 markets. The company has a strong position in India and the US across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin, with a workforce of over 24,000 professionals, has 15 state-of-the-art manufacturing sites and seven research centres globally. Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions are subsidiaries.
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New strength
- Lupin is India’s multinational pharmaceutical company
- The company has received approval from the US Food and Drug Administration (US FDA) for risperidone long-acting injectable.
- It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Quote
“PrecisionSphere’s proven capabilities, combined with our track record of successful partnerships, uniquely position us to expand global access to advanced long-acting injectable treatments.”
Dr Fabrice Egros
President – Corporate Development
Lupin
Caring public by HLL Lifecare
AMRIT Pharmacy
The public sector Mini-Ratna HLL Lifecare has contributed significantly to the successful implementation of the AMRIT Pharmacy scheme, which helped nearly 70 million people save on their medicine costs.
AMRIT (Affordable Medicines and Reliable Implants for Treatment) Pharmacy completed 10 years. The establishment of AMRIT Pharmacy marked a significant milestone in affordable medicine access. It also ensures the public sector’s continuing commitment to universal health coverage. Since its inception in 2015, the vast AMRIT network has been instrumental in providing life-saving and essential medicines at discounts ranging from 50 per cent to 90 per cent, bringing down treatment costs, especially for those from low-income backgrounds.
J P Nadda, Union Minister of Health and Family Welfare, praised HLL Lifecare Ltd. for its consistent and high-quality efforts in implementing AMRIT as an implementing agency. It was with the vision of making healthcare accessible, affordable, and equitable for all citizens that Jan Aushadhi and AMRIT were conceived. AMRIT has grown into a robust national network, with over 255 pharmacies currently operational, with a vision to expand the network to 500 outlets across the country. Every AIIMS in the country has an AMRIT pharmacy. The next challenge is to ensure that every medical college and every district hospital in India is equipped with an AMRIT pharmacy, so that affordable medicines reach citizens at every level of the healthcare system.
The offer of 50 per cent discounts on branded medicines benefited more than 68.50 million patients, as the AMRIT network delivered medicines worth over ₹17,000 at MRP. It resulted in cumulative savings of approximately ₹8,400 crore for patients. It is crucial to raise public awareness about AMRIT pharmacies, and more citizens should be informed about the benefits and availability of AMRIT outlets to help them take advantage of these benefits.
Continuous guidance of senior officials of the Ministry of Health and Family Welfare and the Health Secretaries has been vital in driving AMRIT’s growth over the last decade, says Dr Anitha Thampi, Chairperson and Managing Director of HLL Life Care. She appreciated the tireless dedication of the HLL and AMRIT teams, whose commitment on the ground has ensured that affordable medicines are available to all citizens.
JP Nadda inaugurated 10 more AMRIT outlets across India, marking a significant step toward enhancing affordable access to essential medicines and medical supplies for patients nationwide. He also launched AMRIT ITes – Eco Green Version 2.0, an upgraded and environmentally sustainable digital platform that will streamline operations, enhance transparency, and improve efficiency across the AMRIT network. The event also featured the release of Customised My Stamp in association with India Post.
HLL Lifecare is a Mini Ratna Public Sector Enterprise under the Ministry of Health and Family Welfare. The company has a diverse portfolio spanning contraceptives, hospital products, medical devices, and services, including diagnostic services under the brand Hindlabs, retail business under AMRIT, HLL Pharmacy, HLL Optical, infrastructure development, procurement services and consultancy. This makes HLL a comprehensive healthcare solutions provider. It has seven state-of-the-art factories, five subsidiaries and a corporate R&D centre, driving innovation in India’s healthcare sector.
“HLL family and the AMRIT pharmacy network have assured that they will continue to expand the network, improve systems, and further strengthen operations with Josh, Junoon and Jazbaat—energy, enthusiasm and spirit,” says Punya Salila Srivastava, Union Health Secretary, Ministry of Health and Family Welfare
Medicine affordability
- AMRIT network supplies life-saving and essential medicines at discounts of between 50 and 90 per cent
- HLL Lifecare portfolio includes contraceptives, hospital products, and medical devices.
- It serves people with diagnostic services under the brand Hindlabs
- Its retail business covers AMRIT, HLL Pharmacy, and HLL Optical
- It also provides infrastructure development, procurement services and consultancy.
Review of diagnosis
Superhealth’s Honest Second Opinion
India’s first zero-wait, zero-commission hospital network, Superhealth, has launched Honest Second Opinion, a groundbreaking service that helps patients make informed decisions about their treatment plans and surgical recommendations. Its flagship hospital is in Koramangala, Bengaluru.
Patients undergo medical procedures only when truly necessary – not out of fear, pressure, or profit. The service is completely free, even for those who are not Superhealth VIP Pass members, says the company. The idea for Honest Second Opinion was inspired by a true story. A young female patient visitedSuperhealth for a second opinion after being told by multiple hospitals that she urgently required a pacemaker implantation. For someone her age, that recommendation carried life-long implications- at least four future replacement surgeries, each one major and risk-laden. The financial impact alone would have been devastating, with the total cost of such procedures reaching as high as ₹15 lakhs.
At Superhealth, the management indicated in a press communique that her case wasn’t rushed through a quick two-minute consultation. Instead, a multi-speciality team that included a cardiologist, dermatologist and pharmacology consultant spent hours understanding her complete medical history, lifestyle, and prescriptions before making any recommendation. That diligence revealed that her heart rhythm issue wasn’t permanent. It was an adverse drug interaction caused by three acne medications prescribed together. With the right diagnosis and medication change, her heart rhythm normalised. No implant, no surgery, no unnecessary risk. As a Superhealth VIP Pass holder, all her consultations and diagnostic tests, worth nearly ₹35,000, were completely free of charge as part of her VIP package.
“At Superhealth, doctors are free from the pressures that can often exist in legacy healthcare systems, says Varun Dubey, Founder and CEO of the hospital. Patients listen, ask and understand because medicine is not a race. “With Honest Second Opinion, we’re putting the power back in the patient’s hands, guided by transparency, empathy, and science. Every treatment begins with one question: What’s best for the patient?. To make sure that everyone can benefit from it, we’re making this completely free. Email us your reports and meet our doctors, and they will tell you whether you really need this surgery or not,” says Dubey. Across India, 10- 15 per cent of outpatient consultations result in surgery. Superhealth tries everything possible to ensure its team can mitigate the necessity of surgery. In fact, Superhealth prescribes surgery in less than half the cases compared to industry standards,” Dubey points out.
Honest Second Opinion is a comprehensive, unhurried review of diagnosis, treatment plan, and surgery that has been recommended elsewhere. The hospital offers free access for all patients, regardless of Superhealth membership status.
With world-class infrastructure, full-time senior doctors, advanced AI systems, and a radical zero-commission model, Superhealth is building a 100-hospital network designed for simplicity, transparency, and trust. For families, Superhealth’s VIP Pass makes access to doctors effortless, covering up to four members with unlimited consultations and tests or scans prescribed by its doctors, even MRIs.
Advantage Superhealth
- Honest Second Opinion is a comprehensive, unhurried review of the diagnosis for an infallible treatment plan
- Doctors are not under pressure to meet targets, as seen in the legacy healthcare systems in the private sector
- Surgeries are recommended only in unavoidable cases
- Superhealth offers a VIP Pass for effortless access to doctors
