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INTERVIEW #SpeakPharma

[Sponsored by another company]
“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.

Impressions: 103

https://www.pharmacompass.com/speak-pharma/we-re-investing-in-next-gen-cdmo-peptide-building-blocks-infrastructure-to-support-the-evolving-demands-of-complex-therapies

PharmaCompass
24 Mar 2026

VLOG #PharmaReel

[Sponsored by another company]
This PharmaReel highlights Rusan Pharma’s 30+ years of expertise in addiction treatment and pain management, specializing in narcotics and psychotropics. Its capabilities span APIs, intermediates, and formulations, supported by backward-integrated manufacturing and GMP-approved facilities certified by USFDA, ANVISA, EMA, PMDA, TGA, and Health Canada.

Impressions: 313

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DATA COMPILATION #PharmaFlow

[Sponsored by another company]
FDA approvals drop 8% in 2025, with fewer blockbusters; Brinsupri, Rhapsido make it to first-in-class list
Our update for new drug approvals by the US Food and Drug Administration (FDA) in the first half (H1) of 2025 had pointed out how upheavals at the agency had impacted its functioning, with drug approvals dropping by 24 percent.While the turbulence didn’t subside, approvals picked up considerably in the second half (H2) of 2025. FDA’s Center for Drug Evaluation and Research (CDER) approved 30 new drugs in H2 (as against 16 in H1), taking the total number of approvals for 2025 up to 46. This is an 8 percent drop compared with 50 approvals CDER had granted in 2024.During the year, CDER saw four new chiefs come and go — Jacqueline Corrigan-Curay (Jan-July 2025), George Tidmarsh (July-Nov 2025), Richard Pazdur (Nov-December 2025) and Tracy Beth Høeg (December 2025-present). In addition, the agency endured thousands of retrenchments. The US Department of Health and Human Services (HHS), under Health Secretary Robert F. Kennedy Jr., enforced funding cuts and changes in approval processes, especially for vaccines.Overall, we have been witnessing a steady drop in drug approvals by CDER — it approved 55 new drugs in 2023, 50 in 2024 and, 46 in 2025.Of the 46 new approvals in 2025, 20 were classified as first-in-class (therapies that use a new and unique mechanism of action), out of which 13 were approved in H2 2025. Overall, CDER approved 32 chemical entities and 14 biologics in 2025.In comparison, approvals by Health Canada and authorizations by the European Medicines Agency (EMA) rose in 2025. The EMA authorized 69 new therapies, up from 64 in 2024. Health Canada approved 46 new therapies in 2025, as compared with 28 in 2024.FDA’s Center for Biologics Evaluation and Research (CBER) approved 21 biologics in 2025, compared with 13 in 2024, of which eight were notable new drugs.Interestingly, both CDER and CBER rejected more drugs last year — 43 applications were rejected, including those for new drugs, supplemental filings, generics and biosimilars, as opposed to 29 in 2024. View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)Blockbuster drug approvals drop by 60%, European drugmakers score more FDA nods It wasn’t a year of blockbuster drug approvals — the agency approved a lower number of drugs that are expected to deliver sales of at least US$ 1 billion by 2030. While there were nearly 20 such drugs approved in 2024, the number dropped to just eight in 2025.Interestingly, European companies won many more approvals for new products than their counterparts in the US. GSK and Novartis achieved three approvals each, while Merck, Boehringer Ingelheim and Bayer AG won two approvals each.The first-in-class drugs approved in H2 are: Insmed's Brinsupri (brensocatib), Ionis's Dawnzera (donidalorsen), Stealth Bio's Forzinity (elamipretide), Boehringer's Jascayd (nerandomilast), UCB's Kygevvi (doxecitine and doxribtimine), Bayer's Lynkuet (elinzanetant), Chimerix's Modeyso (dordaviprone), Innoviva's Nuzolvence (zoliflodacin), Arrowhead's Redemplo (plozasiran), Novartis' Rhapsido (remibrutinib), Otsuka's Voyxact (sibeprenlimab-szsi), Sanofi's Wayrilz (rilzabrutinib) and Omeros' Yartemlea (narsoplimab-wuug). View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)Insmed’s Brinsupri approved for chronic lung disease; Novartis’ Rhapsido okayed for urticariaAs has been the trend, the field of oncology saw the maximum drug approvals (15), followed by rare diseases and disorders (7) and immunology (4). Three categories — infections and infectious diseases, respiratory diseases and cardiology/vascular diseases — saw three drug approvals each.Among the first-in-class approvals was Insmed’s Brinsupri (brensocatib), the first treatment for non-cystic fibrosis bronchiectasis, a chronic lung disease. Nature has estimated peak sales of US$ 6.3 billion for this treatment. Brinsupri was approved by the EMA in November.Another notable approval was granted to Novartis’ Rhapsido (remibrutinib), approved to treat the skin condition chronic spontaneous urticaria in adults who remain symptomatic despite treatment with antihistamines. Rhapsido is the first oral alternative to injectable treatments and has 2030 sales forecasts of US$ 2.1 billion. Novartis is also testing the drug for other immune conditions.A new drug that is estimated to bring in the maximum sales is Merck’s Keytruda Qlex, a subcutaneous formulation of pembrolizumab plus berahyaluronidase alfa approved for various solid tumors. While top-selling cancer drug Keytruda (pembrolizumab) was first approved in 2014, this is the first approval for an engineered variant of the hyaluronidase enzyme (berahyaluronidase alfa). Therefore, this combination counts as a novel approval. View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)Fondazion’s CGT okayed for Wiskott-Aldrich syndrome; three drugs approved for hereditary angioedema After a record nine new cell and gene therapy (CGT) approvals in 2024, only five CGTs were approved in 2025 (the lowest since 2022). With the exception of Novartis’ Itvisma (onasemnogene abeparvovec-brve), all other CGT approvals went to relatively lesser known companies such as Abeona, Precigen, Neurotech and Fondazione Telethon (an Italian firm that became the first nonprofit to get a CGT approval from the FDA).Fondazione Telethon’s Waskyra (etuvetidigene autotemcel) became the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare immune disorder that causes frequent infections, bleeding issues, and eczema. The one-time treatment uses patients’ own blood stem cells that are modified to restore the faulty WAS gene. Abeona’s Zevaskyntm (prademagene zamikeracel) became the first and only autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (a rare, genetic skin disorder).Patients with hereditary angioedema (or HAE, a genetic disorder characterized by recurrent episodes of severe swelling) gained access to three new drugs, including two first-in-class drugs — CSL Behring’s Andembry (garadacimab) and Ionis Pharma’s Dawnzera (donidalorsen). The third drug approved to treat HAE is KalVista Pharma’s Ekterly (sebetralstat). View New Drug Approvals in 2025 with Estimated Sales (Free Excel Available)Our viewThe FDA has been bringing about considerable changes to its processes. In June, it launched the Commissioner’s National Priority Vouchers (CNPV) program to cut review timelines from the usual 10 to 12 months to two months. But the recent rejection of Disc Medicine’s application for bitopertin as a treatment for a rare blood disorder under the program took four months to materialize. Not only did the rejection come in late, it was based on information already known to the FDA at the time of granting the coveted voucher, raising controversy around the program.The agency is going to bring about more changes soon. It has proposed a plausible mechanism pathway for rare and ultra-rare diseases where randomized controlled trials are not feasible. And in April, it announced plans to phase out animal toxicity testing in the development of monoclonal antibody therapies and other drugs. The agency is increasingly relying on AI, and recently  announced the deployment of agentic AI capabilities for all employees. It will be interesting to see how these changes impact drug approvals in 2026.

Impressions: 1286

https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-8-in-2025-with-fewer-blockbusters-brinsupri-rhapsido-make-it-to-first-in-class-list

#PharmaFlow by PHARMACOMPASS
26 Feb 2026