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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.”

    mic“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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    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
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaGlobal Leader in HPLE ExcipientsGlobal Leader in HPLE Excipients

    Global Leader in HPLE Excipients
    Global Leader in HPLE Excipients

    reelGlobal Leader in HPLE Excipients

    This PharmaReel highlights Pfanstiehl, a global leader in high-purity, low-endotoxin, low-metal injectable-grade excipients for biologic formulations under cGMP standards, with expertise in isolation, purification, custom synthesis, and scale-up from gram-scale to multi-ton production.

    Impressions: 5

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

    The market for pharmaceutical excipients — or inactive substances used in the production of drugs —  continued to witness significant transformation in the first quarter (Q1) of 2026. The rise of biologics, increasing demand for personalized medicine, and innovations in drug delivery systems are driving demand for a wider range of functional excipients. As a result, the pharmaceutical excipients market is estimated to grow at a compound annual growth rate (CAGR) of 5.75 percent, to exceed US$ 15.43 billion by 2034. Its size was estimated at US$ 9.31 billion in 2025. The North American market for excipients was estimated at US$ 3.1 billion in 2024 and is estimated to increase to US$ 5.66 billion by 2034. In comparison, the European market for pharmaceutical excipients was estimated at US$ 2.35 billion in 2024 and is predicted to reach around US$ 3.95 billion by 2034, while the Asia Pacific market stood at US$ 1.94 billion in 2024 and is projected to grow to US$ 3.65 billion by 2034.The sector remains highly competitive and fragmented. Major excipient providers include BASF, Roquette, Gangwal Healthcare, Croda International, DuPont, Seqens, SPI Pharma, Evonik, PMC Isochem, Pfanstiehl, Colorcon, Kewpie Corporation, ICE Pharma, Nanjing Well Pharmaceutical, Merck KGaA-owned MilliporeSigma, Minakem, Ashland Global and Nippon Fine Chemical.Clariant sets up its first PEG excipients facility in US; Croda opens greenfield facility in India Swiss specialty chemical company Clariant is expanding its Clear Lake (Texas) site to include GMP-compliant manufacturing of pharmaceutical-grade polyethylene glycol (PEG) excipients. This will improve availability and reliability for North American customers, with extended reach to Latin America. The multi-phase expansion addresses critical industry priorities around supply chain security, continuity, and responsiveness while demonstrating Clariant’s long-term strategic commitment to the US pharmaceutical market. This is the first Clariant facility in the US to manufacture PEG excipients for oral and topical applications.British specialty chemicals company Croda International has inaugurated a greenfield manufacturing facility in Dahej, India, that strengthens its ability to serve fast-growing markets in Asia. The new site represents a significant investment in India and will enhance Croda’s supply capabilities, improve responsiveness to customer demand, and support future growth in high-value sectors. Located in Gujarat, the facility benefits from strong logistics connectivity and is designed to serve both domestic customers and select export markets. It will support demand across Croda’s consumer care, life sciences, and industrial specialties sectors. Following the acquisition of IFF Pharma Solutions in 2025, French excipient company Roquette has introduced an expanded cosmetics portfolio under the Roquette Beauté brand. This portfolio integrates IFF Pharma Solutions’ ingredients — Methocel, Avicel, Aquacoat, Ethocel, and Polyox — with Roquette’s legacy range, while its core portfolio continues to include widely used pharmaceutical excipients. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)SPI Pharma-Anek Prayog, Ingredion-Univar ink distribution deals; DFE Pharma, Gericke launch CM platformIn February, US-based pharmaceutical excipient and ingredients company SPI Pharma announced a global distribution partnership with Indian pharmaceutical excipient manufacturer Anek Prayog. Under this agreement, SPI will exclusively sell, promote, and distribute Lubripharm Pro SSF, a next-generation sodium stearyl fumarate lubricant manufactured by Anek Prayog.The Ingredients + Specialties division of Univar Solutions was appointed as a distributor for Ingredion Pharma Solutions. The agreement includes distribution of Ingredion’s global pharmaceuticals portfolio and positions Univar as the exclusive distributor of pharmaceutical starches in the US and Canada. The partnership expands its pharmaceutical and nutraceutical excipient offerings, including binders, fillers, superdisintegrants, lubricants, and gelatin alternatives.German excipient solutions company DFE Pharma has launched a continuous manufacturing (CM) platform in collaboration with Switzerland-based Gericke Group to support formulation development, optimization, and lifecycle management. The platform integrates CM-ready excipients, a flexible evaluation environment, and multidisciplinary expertise to enable data-driven decisions from early development to commercial manufacturing.As part of this initiative, DFE Pharma has established CM capabilities at its C2F Center of Excellence in Hyderabad, featuring a Gericke Formulation Skid (GFS) in a non-GMP setup. This modular system enables rapid testing, process optimization, and practical assessment of continuous feeding and blending without impacting existing GMP operations, while supporting alignment with ICH Q13 (an international guideline on CM for drug substances and products).Gangwal Healthcare operates EXCiPACT-certified GMP facilities and offers a broad range of functional excipients, including co-processed blends like ProBlend, Starlose, Tyloxapole, and Microlose. Its excipients, including Solvostar (sodium starch glycolate) and LubMag-W (Magnesium Stearate, Sodium Lauryl Sulfate), support enhanced tablet disintegration and drug release. The company also provides taste-masking agents such as SucreX (sucralose) and CutCal (neotame), supporting the development of patient-friendly oral dosage forms. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)India harmonizes 22 excipient monographs; EMA updates TE guidelines for inhalation products Regulators are increasingly tightening requirements around excipients, as they are no longer treated as passive ingredients. They are being recognized as critical to product performance and therapeutic equivalence.India has introduced the Indian Pharmacopoeia 2026 with updated and harmonized standards for pharmaceutical ingredients, including 22 excipient monographs. These revisions align Indian standards more closely with global pharmacopoeias. For excipient manufacturers and drug formulators, this means stricter compliance expectations. In August, India had notified an amendment to the Drugs Rules, 1945 to mandate inclusion of qualitative details of excipients in drug labels through barcodes or QR codes from 2026.The European Medicines Agency (EMA) has issued updated guidelines on the pharmaceutical quality of inhalation and nasal medicines, as well as on demonstrating therapeutic equivalence (TE) of orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease. These guidelines require manufacturers to provide detailed information on the active substance, finished product composition, pharmaceutical development studies, and the control of excipients and other formulation components. Similar pharmaceutical quality requirements apply to nasal products under the pharmaceutical quality guideline.Excipients are becoming increasingly linked to manufacturing technologies. For instance, the US Food and Drug Administration (FDA) finalized its Advanced Manufacturing Technologies (AMT) Designation Program in 2024. This is expected to increase the need for excipients compatible with such technologies. View Our Dashboard on Major Excipient Companies in 2026 (Free Excel Available)Our view While the market for excipients is growing at a healthy pace, the ongoing conflict in the Middle East is disrupting pharmaceutical supply chains, with impacts now extending beyond APIs to critical excipients and packaging materials. Surging crude oil prices are driving up the cost of excipients, with key inputs like chloroform witnessing sharp price increases. In addition, disruptions in logistics are forcing drugmakers to reroute shipments through longer and more expensive routes due to closure of airports and certain sea routes. These developments will have a cascading effect on the pharmaceutical industry and its supply chain in the coming months.
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    https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-clariant-sets-up-its-first-peg-excipients-facility-in-us-india-harmonizes-22-excipient-monographs

    #PharmaFlow by PHARMACOMPASS
    26 Mar 2026
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    NEWS #PharmaBuzz

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    Teva Gains Biosimilar Momentum with Approval of Ponlimsi &Xolair
    Teva Gains Biosimilar Momentum with Approval of Ponlimsi &Xolair

    30 Mar 2026

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2026/03/30/3264544/0/en/Teva-Gains-Biosimilar-Momentum-with-U-S-FDA-Approval-of-PONLIMSI-denosumab-adet-and-Dual-Filing-Acceptance-for-Biosimilar-Candidate-to-Xolair-omalizumab.html

    GLOBENEWSWIRE
    30 Mar 2026
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    Teva’s Generics Nintedanib Receives Tentative Approval in US
    Teva’s Generics Nintedanib Receives Tentative Approval in US

    26 Mar 2026

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219371

    FDA
    26 Mar 2026
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    Biolojic Earns Teva Milestone for First AI Multibody TEV '325
    Biolojic Earns Teva Milestone for First AI Multibody TEV '325

    25 Mar 2026

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2026/03/25/3262066/0/en/Biolojic-Design-Earns-Preclinical-Milestone-from-Teva-for-First-AI-Designed-Multibody-in-Autoimmune-Disease-TEV-325-formerly-BD9.html

    GLOBENEWSWIRE
    25 Mar 2026
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    Teva Releases Q1 2026 Aide Memoire
    Teva Releases Q1 2026 Aide Memoire

    19 Mar 2026

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2026/03/19/3259458/0/en/Teva-Releases-Q1-2026-Aide-Memoire.html

    GLOBENEWSWIRE
    19 Mar 2026
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    Teva To Discuss Q1 2026 Financial Results In Conference Call
    Teva To Discuss Q1 2026 Financial Results In Conference Call

    19 Mar 2026

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2026/03/19/3259456/0/en/Teva-to-Host-Conference-Call-to-Discuss-First-Quarter-2026-Financial-Results-at-8-a-m-ET-on-April-29-2026.html

    GLOBENEWSWIRE
    19 Mar 2026
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    Pfizer, Teva lose bid to disqualify ex-prosecutor in generic drug
    Pfizer, Teva lose bid to disqualify ex-prosecutor in generic drug

    12 Mar 2026

    // REUTERS

    https://www.reuters.com/legal/litigation/pfizer-teva-lose-bid-disqualify-ex-prosecutor-generic-drug-pricefixing-case-2026-03-11/

    REUTERS
    12 Mar 2026
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