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INTERVIEW #SpeakPharma

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“We’re investing in next-gen CDMO & peptide building blocks infrastructure to support the evolving demands of complex therapies.”

This week, SpeakPharma interviews Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions (LMS). In this exclusive interview with PharmaCompass, Dr. Toumi discusses the evolving CDMO landscape, the shift toward complex therapies and growing peptide ecosystems along with LMS’s recent strategic investments in integrated CDMO and peptide building blocks infrastructure. As the industry convenes at DCAT Week, he highlights how LMS is positioning itself as a capability-driven CDMO partner for next-gen complex therapies.Dr. Toumi, The US has been taking several steps to reduce dependence on overseas pharmaceutical supply chains. How is Lupin Manufacturing Solutions (LMS) navigating these shifts?The framing of this debate as globalization versus reshoring misses what is actually happening. What we are seeing is a deliberate recalibration, a move from networks built purely for cost efficiency toward architectures that distribute risk more intelligently. That is a fundamentally different objective, and it changes what pharmaceutical companies expect from their manufacturing partners. What policymakers are pushing for, whether through the BIOSECURE Act or broader reshoring incentives, is a strategic allocation of manufacturing risk, and that is entirely rational.For LMS, this environment plays to our strengths. We have never positioned ourselves as a low-cost volume provider. Our competitive case is built on technical capability, regulatory reliability, and the ability to manage genuinely complex chemistry programs. Those attributes matter most to customers re-evaluating their supply relationships. Our investments in HPAPI containment, peptide building blocks, and integrated CDMO infrastructure reflect a deliberate commitment to being relevant precisely where complexity is highest. That is where we see sustained and growing demand, irrespective of how supply chain policy continues to evolve.How do you see the pharmaceutical landscape evolving over the next five years? How is LMS positioning itself to stay ahead of these changes?Five years from now, the defining feature of this industry will be the sheer scientific complexity embedded in pharmaceutical pipelines. Peptides, targeted oncology compounds, radiopharmaceuticals, these are not molecules you manufacture through conventional means. They demand deep process chemistry, specialized infrastructure, and partners who can genuinely co-develop solutions rather than simply execute a manufacturing order.That shift is changing how innovation-driven companies select their CDMO partners. Technical depth, regulatory track record, and the ability to navigate development risk have moved to the top of the evaluation criteria. At LMS, everything we are building right from our integrated CDMO block at Dabhasa to our HPAPI infrastructure at Vizag is calibrated to this reality. We are positioning to be a partner of choice and not just a transactional service provider.Could you provide an update on LMS’ oncology (HPAPI) manufacturing block in Visakhapatnam? How is it contributing to your CDMO strategy?Oncology manufacturing is one of the most technically exciting segments in the industry, and that complexity is only intensifying. As targeted therapies and antibody drug conjugates advance through pipelines, the demand for high-potency API capability delivered reliably, at global safety standards continues to grow.Our Vizag facility has been designed with that reality in mind, and that goes beyond containment engineering. It incorporates the process discipline, safety culture, and quality systems that high-potency manufacturing demands at every level of the organization. You cannot retrofit this kind of capability; it has to be purpose-built. What we have put in place is a platform that supports programs from early clinical development through commercial supply offering customers the continuity they need without transferring between sites as their programs mature. That continuity is a genuine competitive advantage.In December, LMS signed a strategic alliance with PolyPeptide Group AG to scale the global peptide supply chain. How will this collaboration strengthen your CDMO capabilities in the fast-growing peptide therapeutics segment?The rapid growth of peptide therapeutics, especially GLP1s, has fundamentally changed how the industry thinks about scale, reliability, and supply security. What was once a niche capability has become a core requirement, and customers are now looking for partners who can support the peptide value chain end-to-end, at a global scale.LMS’s strategy is built around serving the entire peptide market and establishing a globally competitive platform over the next three to five years, rooted in India, positioning itself as a credible partner amidst the China+1 strategy, capable of supporting both innovators and large pharmaceutical companies. The strategic alliance with PolyPeptide Group fits naturally within this vision allowing us to complement our own capabilities with additional synthesis depth and geographic flexibility, particularly for customers seeking resilient, diversified supply chains.LMS brings deep process chemistry expertise, a growing peptide intermediates and building blocks platform at Dabhasa, and strong regulatory execution. Importantly, as part of the Lupin group, we are also able to offer downstream drug product manufacturing capabilities spanning oral formulations as well as sterile injectables, including vials and drug-device delivery systems, which are increasingly critical as peptide programs move rapidly from development to commercial scale.Together, this integrated approach allows us to support customers across the full lifecycle, from peptide intermediates and APIs through to finished dosage forms. In a market defined by speed, scale, and supply assurance, this breadth of capability positions LMS to emerge as one of the leading global players in peptide CDMO services.As the industry convenes at DCAT Week, what is LMS bringing to the table this year?This year is about laying the foundations for LMS’s next phase of growth, particularly in complex and high value modalities. Strategically, our focus is on building the capabilities required to support emerging oncology and peptide adjacent platforms, while preparing for commercial scale-up over the next 18-24 months.On the technology side, LMS already has strong R&D capabilities across peptides, payloads and linkers, bioconjugation, and high potent compounds. These capabilities allow us to engage with customers early in development, solve complex chemistry challenges, and support rapid transition from discovery into development programs. Building on this base, we are progressing plans to establish commercial-scale GMP capacities in payload-linker synthesis and bioconjugation, including the development of a dedicated GMP facility in Vizag. This is a critical step for us as more antibody drug conjugates and related platforms move toward late-stage development and commercialization.Equally important is how we engage with customers. Alongside traditional CDMO models, we are increasingly offering alternative business models such as dedicated facilities, long-term capacity commitments, and guaranteed supply arrangements designed to address customers’ growing concerns around security, scalability, and speed to market. Overall, the year ahead is about execution including strengthening our R&D engine, advancing commercial-scale infrastructure, and deepening customer partnerships so that LMS is well positioned to support complex programs as they move into clinical and commercial reality.LMS has articulated its ambition to emerge as a trusted global CDMO partner with next-generation manufacturing capabilities and scientific agility. How would you assess your progress toward that goal?Trusted partnerships are earned over time, and I am clear-eyed about that. What I can say with confidence is that the strategic choices we have made over the past year have been the right ones, and the investment portfolio we have assembled aligns with direction the industry is heading.The development of our integrated CDMO block at Dabhasa, the scaling of peptide building blocks capabilities, the Vizag HPAPI facility, the PolyPeptide alliance, these reflect a coherent long-term strategy. What continues to occupy my attention most is execution. Infrastructure sets the stage, but it is our science, our quality systems, and our people that customers will ultimately judge us by. That work is ongoing, and it is where I spend most of my time.Could you update us on LMS’ green manufacturing initiatives? How is sustainability being integrated into your operations and facilities?Sustainability has shifted from a compliance requirement to a genuine competitive dimension, and I think that shift is permanent. Customers, investors, and regulators are asking harder questions, and organizations treating it just as a reporting exercise will find themselves at a disadvantage.Our approach remains grounded in the belief that durable environmental improvement comes from process intelligence. When you optimize synthesis routes for atom economy, reduce solvent intensity, and engineer waste out at the design stage, you improve sustainability and manufacturing economics simultaneously. These are not competing priorities. We are embedding green chemistry principles across our development workflows and investing in solvent recovery and waste management infrastructure. Our parent organization Lupin Limited was recently recognized among the top 1% of companies worldwide in the S&P Global Corporate Sustainability Assessment (CSA) attaining an overall score of 91 out of 100 establishing itself as the leading pharmaceutical company globally, and the leader across all sectors in India, surpassing both Indian and international peers which underscores our commitment.

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VLOG #PharmaReel

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Aseptic Processing of Injectables

This PharmaReel spotlights medac CDMO, a trusted fill & finish partner for complex injectables in vials, pre-filled syringes, and cartridges. Specializing in biologics, ADCs, and HPAPI handling, medac CDMO supports programs from clinical development to commercial supply, backed by FDA, EMA, ANVISA, and PMDA certifications.

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DATA COMPILATION #PharmaFlow

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Prostaglandin market to cross US$ 1.27 bn by 2035; Liquidia’s Yutrepia okayed for pulmonary hypertension

Prostaglandins are natural fatty acid compounds produced by the human body. They are made from a type of fat known as arachidonic acid and act like messengers, controlling many functions such as inflammation, blood flow, muscle contraction, and fluid drainage in the eye. Prostaglandin APIs are synthetic (lab-made) versions of natural prostaglandins that are used to create medicines. Prostaglandin-based medicines are used in obstetrics and gynecology, gastroenterology, urology, and cosmetics, and their use is also being explored in certain cardiovascular and respiratory conditions. One of the largest and most important uses of prostaglandin APIs is in ophthalmology (eye care), where they are used as first-line therapy for open-angle glaucoma (a chronic, progressive eye disease) and ocular hypertension (a condition where pressure inside the eye is consistently higher than normal). In ophthalmic applications, these drugs usually serve as prodrugs – inactive in the formulation but converted into their active form after entering the eye.According to estimates, the global prostaglandin market is valued at US$ 0.63 billion in 2025 and is poised to grow from US$ 0.68 billion in 2026 to US$ 1.27 billion by 2035, growing at a CAGR of 7.1 percent between 2026 and 2035.Prostaglandin API manufacturing is a highly specialised field, with only a few experienced manufacturers. Companies such as EUROAPI, Cayman Pharma, Chirogate International, Kyowa Pharma Chemical, Everlight Chemical, and Yonsung Fine Chemicals are key players with strong capabilities in complex chemistry.FDA allows Glaukos’ iDose TR to be re-administered for treating eye diseases; approves Liquidia’s Yutrepia The prostaglandin market continues to see steady regulatory activity and innovations. In ophthalmology, Glaukos Corporation’s iDose TR received a labelling supplement from the US Food and Drug Administration (FDA) that allows for re-administration of the medication indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The intracameral implant was originally approved in December 2023 for single use. This update was supported by long-term safety data demonstrating good tolerability in patients with OAG and OHT. Similarly, Santen Pharmaceutical secured manufacturing and marketing approval in Japan for Setaneo (sepetaprost) ophthalmic solution 0.002% in August 2025 for the treatment of glaucoma and OHT. In April 2025, Santen also received approval in China for Tapcom (tafluprost + timolol maleate), a preservative-free fixed-dose combination therapy that lowers intraocular pressure (IOP) in patients with OAG and OHT.Beyond ophthalmology, prostaglandin APIs are also driving advancements in respiratory care. Liquidia Corporation received FDA approval in May 2025 for Yutrepia (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). While PAH is a serious and progressive disease where blood pressure in the lung arteries rises, causing them to narrow and harden, PH-ILD is a serious complication in which high blood pressure develops in the lung arteries due to lung scarring. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary technology. Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Nicox’s drug scores phase 3 win in glaucoma, OHT; United seeks expanded approval for Tyvaso to treat pulmonary fibrosisInnovation in prostaglandins is increasingly focused on enhanced efficacy and sustained drug delivery. French ophthalmology company Nicox has reported positive phase 3 results for its ophthalmic solution NCX 470, demonstrating consistent lowering of intraocular pressure in OAG and OHT. Nicox is likely to submit a new drug application for NCX 470 sometime soon, with a potential approval and launch expected in 2027.Meanwhile, US-based SpyGlass Pharma is advancing sustained-release innovation through intraocular lens (IOL)-based and ring-based drug delivery systems. Its Bimatoprost Drug Pad–Intraocular Lens (BIM-IOL) system (currently in phase 3 trials) integrates drug delivery with cataract surgery to enable sustained therapy for up to three years. The company is also developing a preclinical Bimatoprost Drug Ring System (BIM-DRS) designed for similarly extended drug release. In respiratory indications, Insmedis progressing treprostinil palmitil inhalation powder through phase 3 trials for PH-ILD, as well as for idiopathic pulmonary fibrosis and PAH.Additionally, United Therapeutics is expanding the clinical scope of Tyvaso DPI (treprostinil). Following its global approval in 2022 for PAH, the therapy is now under regulatory review in the US and Canada for progressive pulmonary fibrosis and idiopathic pulmonary fibrosis. Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Glaukos sets up new R&D facility in Alabama, Inke acquires Pharmanoid to strengthen presence in prostaglandins Several players are expanding capacities due to rising demand across ophthalmology. Glaukos Corporation is setting up a new research, development, and manufacturing facility in Huntsville, Alabama. The planned 200,000 square-foot site, to be built on a 25-acre campus in Cummings Research Park, envisages an investment of over US$ 80 million. Expected to be completed by 2030, the facility is designed to augment the company’s existing infrastructure and support long-term growth, particularly in ophthalmic therapies including sustained-release drug delivery systems.EUROAPIis undertaking a significant capacity expansion at its Budapest site. The company has committed €50 million (US$ 54.8 million) to install a new state-of-the-art production plant focused on prostaglandins. The project aims to debottleneck existing operations and introduce new multi-purpose manufacturing equipment, ultimately more than doubling the site’s prostaglandin production capacity by 2027. The expansion will also strengthen EUROAPI’s highly potent API (HPAPI) capabilities.Alongside capacity additions by established players, the market is also witnessing consolidation and capability expansion through acquisitions. For instance, Essential Pharma acquired Ventavis (iloprost trometamol) from Bayer AG, including rights to the accompanying Breelib nebuliser delivery technology. Ventavis, a prostacyclin analogue, is a well-established treatment for adult patients with primary pulmonary hypertension.Inke strengthened its presence in ophthalmology-focused high-potency APIs (HPAPIs), including prostaglandins, through the acquisition of Pharmanoid in December 2025. Backed by regulatory approvals across 25+ countries, Pharmanoid enhances Inke’s capabilities in complex API production and supports its ambition to build a leading European platform for advanced API development and manufacturing. The Barcelona facility is capable of producing and handling APIs across all potency levels while adhering to SafeBridge Scale OEB4 (Occupational Exposure Band 4) containment protocols, a classification for high-potency substances requiring strict controls to limit occupational exposure.With more than two decades of experience, Inke is recognized for innovating and manufacturing high-quality APIs, delivering expertise, safety, and excellence across inhalation, CNS, and ophthalmic therapies, while supporting pharmaceutical companies worldwide. The ophthalmic API commercial portfolio includes bimatoprost, latanoprost, tafluprost, and travoprost, while the next-generation prostaglandin analog pipeline includes bimatoprost grenod and latanoprostene bunod. Access the Interactive Dashboard on Prostaglandin Developments (Free Excel Available)Our viewInnovation is guiding the prostaglandins market towards long-acting, sustained-release formulations and novel delivery systems. These innovations are driving steady growth in prostaglandins, while capacity expansions are strengthening capabilities in complex and highly potent APIs. Overall, this remains a niche but important market to watch.

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