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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 33 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
33 News #PharmaBuzz

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

INSPECTIONS & REGISTRATIONS

13 FDA

inspections
13 FDA

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About

At Otsuka, we dream and act like a big venture company. For us it all begins with a dream—a dream to help improve the lives of patients and their caregivers. Since our beginnings in 1921, we have been nurturing the spirit of curiosity, creativity, and perseverance in our employees so they may be inspired to pursue their dreams to bring innovative healthcare products to patients and communities worldwide. Our people aren’t afraid to challenge convention. This is what defines big venture. We explore for ourselves rather than rely on the conclusions of others. Together we experiment, and sometimes challenge each other, in our collective passion to discover something new, something better. That is the energy that powers Otsuka. In North America, Otsuka Pharmaceutical Co., Ltd. operates three pharmaceutical companies dedicated to creating and promoting new products and innovative solutions for better health worldwide, with a focus on four specialty areas: neuroscience, oncology, cardio-renal, and medical devices. Explore Otsuka and see what sets us apart.

AIChE Annual MeetingAIChE Annual Meeting

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02-06 November, 2025

Boston, MA
World ADC USAWorld ADC USA

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03-06 November, 2025

San Diego
Bio-EuropeBio-Europe

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03-05 November, 2025

Vienna, Austria

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“We’re expanding our CDMO capabilities to meet the next wave of complex therapies, starting with oncology.”

This week, SpeakPharma interviews Dr. Abdelaziz Toumi, Chief Executive Officer of Lupin Manufacturing Solutions (LMS). With over two decades of global leadership experience in the pharmaceutical and manufacturing sectors, Dr. Toumi has been instrumental in shaping LMS’s transformation into a science-driven, client-centric CDMO. Under his leadership, LMS has expanded into complex APIs, oncology manufacturing, and sustainability-led operations. In this exclusive interview with PharmaCompass, Dr. Toumi shares how the company is reshaping its CDMO strategy to serve the evolving needs of global pharma and biotech clients. He also talks about LMS’s latest milestone — the commissioning of a new dedicated oncology block at its Vizag site as the company strengthens its position in high-potency and complex API development ahead of CPHI Frankfurt. Dr. Abdelaziz, Lupin Manufacturing Solutions has been gaining visibility lately. For those who might not be familiar, how would you describe LMS and its vision within the Lupin Group? LMS represents Lupin’s commitment to extending its scientific excellence and manufacturing quality into the CDMO space. LMS was created with a clear vision to collaborate with innovators, biotech firms, and pharmaceutical companies to accelerate their molecules from development to commercial scale, with the assurance of Lupin’s global quality and compliance standards. In essence, LMS blends Lupin’s heritage of trust with the flexibility and customer-focus of a pure-play CDMO. That’s our DNA. HIGHLIGHTS// Extending scientific excellence to CDMO/assurance of global quality, compliance standards/blending heritage of trust with flexibility, customer focus What makes LMS different in an increasingly competitive global CDMO market? The CDMO industry today is not about who has the largest capacity. Rather, it’s about who brings the most value, scientific innovation and speed to the table. Our edge lies in complex chemistry capabilities, deep regulatory expertise, and a culture built around collaboration and accountability. We focus on areas where precision and containment matter, including highly potent APIs (HPAPIs), oncology, and niche small molecules, and we back that up with teams who think beyond manufacturing, toward solving our clients’ development and commercialization challenges. HIGHLIGHTS// Complex chemistry capabilities/deep regulatory expertise/culture built around collaboration and accountability Dr. Abdelaziz, you mentioned oncology as a key focus area. Can you share more about LMS’s plans in this space? Yes, and I am happy to share this first with PharmaCompass — that we have just commissioned our new oncology block at our Vizag site, which is now operationally ready. This is a major step forward for LMS. The facility has been purpose-built for HPAPIs and oncology APIs, and is equipped with advanced containment systems, over 20 reactors and more than 20 isolators. It has a team of over 100 highly skilled scientists specializing in complex and hazardous chemistries. It expands both our capacity and our confidence to support partners in developing targeted cancer therapies. More importantly, it signals our intent — that we are serious about being a global partner of choice in the oncology CDMO space. HIGHLIGHTS// Commissioned new oncology block at Vizag/facility built for HPAPIs, oncology APIs/equipped with advanced containment systems/100 skilled scientists That’s an exciting development. What opportunities do you see in the oncology manufacturing segment globally? The oncology segment is transforming the pharmaceutical landscape. Globally, it is one of the segments with the highest number of development drugs in the pipeline. With the rise of targeted therapies, potent compounds, and smaller-volume high-value APIs, clients are looking for CDMO partners who combine containment expertise with speed and reliability. We see a strong opportunity here, especially as innovators look to move from lab to commercial scale faster, without compromising safety or compliance. LMS is stepping into this gap with the right infrastructure, people, and mindset to deliver. HIGHLIGHTS// Oncology transforming pharmaceutical landscape/highest number of drugs in pipeline/clients looking for CDMOs in oncology space CPHI Frankfurt is around the corner. What can we expect from LMS this year? This CPHI will be a defining one for us. We will be showcasing LMS as a comprehensive small-molecule CDMO, with a sharpened focus on high-potency and oncology manufacturing. Our conversations in Frankfurt will center around how we can help clients navigate development complexity with the confidence of partnering with a science-first, quality-driven CDMO. People will see a refreshed LMS — one that’s growing fast, innovating continuously, and thinking globally. HIGHLIGHTS// Frankfurt CPHI to be a defining one for LMS/helping clients navigate development complexity with confidence/science-first, quality-driven CDMO Quality and sustainability are gaining importance in CDMO partnerships. How is LMS addressing these dimensions? For us, quality and sustainability are a part of our culture. Every process at LMS is anchored in patient safety, compliance, and continuous improvement. Our regulatory systems are built on Lupin’s decades of global experience, and we are leveraging that legacy in every project we take on. On sustainability, we are investing in green chemistry principles, waste minimization, and energy-efficient operations. We believe responsible manufacturing is not just an ESG statement; it’s good business and essential for long-term trust. HIGHLIGHTS// Quality, sustainability part of culture/processes anchored in patient safety, compliance/regulatory systems built on decades of global experience/investing in sustainability Partnership seems to be a recurring theme for LMS. How do you define a true CDMO partnership? A real partnership starts with shared ambition. We see ourselves not just as a manufacturer, but as an innovation partner working as an extension of our client’s R&D and operations teams. The most successful projects we have delivered are those where we have been involved early, and those that align us on the development strategy, risk management, and commercial readiness. That is what we mean when we say we are building science-led partnerships — these are partnerships that are collaborative, transparent, and outcome-driven. HIGHLIGHTS// Innovation partner working as an extension of clients’ R&D, ops team/need to involve LMS early for successful projects/building science-led partnerships Finally, what is next for LMS as you look beyond this milestone? The oncology block is just the beginning of a larger journey. We are scaling our analytical and development services, peptide synthesis capabilities, adding bioconjugation services, expanding global business development, and investing in digital and automation initiatives to make project execution even more seamless. Our goal is to evolve into a trusted global CDMO partner that combines Lupin’s credibility with next-generation manufacturing and scientific agility. As I like to say – we are not just manufacturing APIs; we are manufacturing trust, innovation, and long-term partnerships. HIGHLIGHTS// Scaling analytical, development services, peptide synthesis capabilities/adding bioconjugation services/expanding global business/investing in digital initiatives

Impressions: 1015

VLOG #PharmaReel

[Sponsored by another company]

Partner in End-to-End API Manufacturing

This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

Impressions: 3357

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey. NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region. Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers. View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.