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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 6 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

49 All APIs, 23 USDMF, 13 CEP/COS, 1 JDMF, 4 EU WC, 10 KDMF, 31 NDC API

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6 FDF Dossiers, 6 FDA Orange Book

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31 All Excipients, 31 USDMF

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INTERVIEW #SpeakPharma

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“We are exploring and piloting AI as part of our strategic IT roadmap to enhance decision‑making and streamline operations.”

This week, SpeakPharma interviews Pere Mañé, Chief Executive Officer of Madrid-headquartered Suanfarma, which provides active pharmaceutical ingredients (APIs) to its 400-odd customers spread across more than 70 countries. Suanfarma’s customized solutions rely on the company’s sharp focus on innovation and sustainability, and a robust global network of 10 strategically located offices. As a CDMO, Suanfarma provides end-to-end solutions for the development and commercialization of intermediates and small-molecule drug substances. In this interview, Mañé talks about Suanfarma’s customer-centric focus, its manufacturing capabilities, strengths, and how it plans to leverage artificial intelligence to elevate industrial performance, reinforce quality, and accelerate commercial effectiveness.Given its global footprint, how is Suanfarma able to strike a balance between maintaining consistent quality, remaining customer-centric, and supporting diverse regulatory and development requirements across markets?At Suanfarma, we apply one global quality standard across all our sites, supported by our strong local regulatory and technical expertise. This allows us to meet the stringent regulatory requirements of regulators like the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and others while staying closely aligned with our customers’ needs. By working collaboratively from the start of each project, we deliver consistent quality, tailored regulatory support, and a truly customer‑centric partnership worldwide.In markets where supply reliability is critical, how does Suanfarma leverage its multi-site manufacturing network, operational flexibility, and logistics capabilities?Suanfarma leverages its multi-site manufacturing network to mitigate risk and ensure continuity of supply. Our operational flexibility allows us to rapidly reallocate capacity, adjust production plans, and respond proactively to demand fluctuations or unforeseen disruptions. This flexibility is supported by robust logistics capabilities, efficient coordination across sites, and reliable delivery performance.From a risk analysis perspective, we prioritize actions that are fully aligned with our strategic goals: strengthening compliance, securing delivery commitments, and building long-term trust with our customers. We are actively streamlining processes and standardizing operations across the network to enhance agility, improve responsiveness, and reduce complexity.By building the foundations of a resilient and compliant platform, Suanfarma ensures not just supply continuity, but also a reliable partnership that supports our customers’ growth in an increasingly volatile market.How does Suanfarma’s TT&GO framework help overcome critical API development and technology-transfer challenges? And what makes it a differentiating element of your CDMO model? Suanfarma’s TT&GO framework addresses critical API development and technology-transfer challenges by transforming tech transfer from a high-risk, reactive step into a structured, risk-based, and predictable process. Integrated into the CDMO project management model, it ensures early and effective knowledge transfer from R&D or external partners to GMP manufacturing, anticipating scale-up, quality, and complexity challenges typical of multi-step APIs and bioconversion processes.What differentiates TT&GO is that it goes beyond documentation. It combines Quality by Design principles, systematic gap and risk analysis, and operational industrial experience to proactively mitigate risks, protect timelines and investments, and accelerate industrialization. This makes TT&GO a core CDMO differentiator, enabling faster, more reliable, and de-risked API commercialization.Suanfarma focuses on continuous improvement of industrial processes to minimize environmental impact. Can you tell us more about the green initiatives Suanfarma has implemented and how they contribute to your overall sustainability strategy? Sustainability is embedded in the way Suanfarma operates. Across our industrial sites, we have implemented energy‑efficiency upgrades, solvent‑recovery installations, advanced wastewater treatment technologies, and circular reuse initiatives (packaging) that significantly cut our environmental footprint.These actions are part of a broader strategy focused on responsible resource management, and continuous improvement. Our goal is to ensure that every innovation not only enhances performance but also contributes to a more sustainable and resilient value chain for our customers, in line with our commitment to providing high quality APIs at affordable prices worldwide.In an increasingly digital and technology-driven industry, how is Suanfarma leveraging innovations in digital tools to stay ahead of the curve?We are modernizing our core systems — including financial reporting, purchasing processes, quality, and data management — to create a solid, secure, and efficient digital backbone, enabling end‑to‑end efficiency and ensuring compliance. This includes a comprehensive cybersecurity action plan, a future‑ready ERP strategy, and a solid infrastructure across all sites.Building on this foundation, we are also exploring and piloting AI as part of our strategic IT roadmap to enhance decision‑making and streamline operations. We are identifying use cases to apply advanced analytics and AI‑driven automation to elevate industrial performance, reinforce quality, and accelerate commercial effectiveness, including production planning, equipment performance, energy efficiency, deviation management, forecasting, sales effectiveness, and customer‑facing.To support this journey, we are evolving our IT team to build the skills and structure needed for the next wave of innovation.

Impressions: 2214

VLOG #PharmaReel

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Expertise in Particle Size Engineering

This PharmaReel highlights Munit SA, a leading player with over 60 years of expertise in Micronization, Milling, and HPAPI Handling. By enhancing solubility and bioavailability, Munit SA delivers innovative pharmaceutical solutions that meet the highest industry standards. Certified by the FDA, PMDA, MHRA, MFDS, and other global authorities, Munit SA ensures excellence and compliance in every micronization process.

Impressions: 1668

DATA COMPILATION #PharmaFlow

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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: 1000

NEWS #PharmaBuzz

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Humanwell’s Generics Tapentadol HCl Receives Approval in US

27 Jan 2026

// FDA

FDA Issues Form 483 to Hubei Gedian Humanwell Pharma

10 Jan 2025

// FDA

FDA Issues Form 483 to Hubei Gedian Humanwell

10 Jan 2025

// FDA

CPHI & PMEC China 2024 Ended Successfully

09 Jul 2024

// PRESS RELEASE

Gedian Humanwell successfully passed the EDQM audit

06 Jun 2024

// PRESS RELEASE

2024 CPhI Exhibition Shanghai

22 May 2024

// PRESS RELEASE

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Hubei Gedian Humanwell Pharmaceutical is a supplier offers 39 products (APIs, Excipients or Intermediates).

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