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    Suanfarma collaboration with the Fight Infections Foundation

    27 Nov 2025

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    Why microbiology matters in API production

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    Logistics as a Strategic Differentiation Tool

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    Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustainable way. With 10 global offices, it serves over 400 customers in 70+ countries. Suanfarma collaborates closely with clients on final formulations, delivering customized solutions and adding value throughout the drug development process. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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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.”

    mic“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.

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    GMP Certificate 2024

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    Suanfarma Appoints Pere Mañé as New CEO to Lead Global Expansion

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    Canagliflozin Hemihydrate: Transforming Type 2 Diabetes Care

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    Strategic Rebranding Initiative under Suanfarma CDMO

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    Intermediates Product List 2024

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    Strategic Cooperation for Anti-infective & Antibacterial APIs

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    Large Volume Anti-infective APIs Through Precision Fermentation

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    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    19 Dec 2024
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    Suanfarma collaboration with the Fight Infections Foundation
    Suanfarma collaboration with the Fight Infections Foundation

    27 Nov 2025

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    https://www.suanfarma.com/esg/suanfarma-and-the-fight-infections-foundation-a-strategic-collaboration-to-advance-global-health/

    PRESS RELEASE
    27 Nov 2025
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    Why microbiology matters in API production
    Why microbiology matters in API production

    21 Oct 2025

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    https://www.suanfarma.com/cdmo/why-microbiology-matters-in-api-production/

    PRESS RELEASE
    21 Oct 2025
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    Logistics as a Strategic Differentiation Tool
    Logistics as a Strategic Differentiation Tool

    23 Sep 2025

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    https://www.suanfarma.com/apis-3/logistics-as-a-strategic-differentiation-tool/

    PRESS RELEASE
    23 Sep 2025
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    Smart Tech Transfer Enhances Pharma Scale Up And Manufacturing
    Smart Tech Transfer Enhances Pharma Scale Up And Manufacturing

    15 Sep 2025

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    https://www.suanfarma.com/cdmo/advancing-pharmaceutical-manufacturing-through-smart-tech-transfer-and-scale-up-strategies/

    PRESS RELEASE
    15 Sep 2025
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    Recognition of Customer Needs in the Pharmaceutical API Industry
    Recognition of Customer Needs in the Pharmaceutical API Industry

    09 Sep 2025

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    https://www.suanfarma.com/apis-3/recognition-of-customer-needs-in-the-pharmaceutical-api-industry/

    PRESS RELEASE
    09 Sep 2025
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    The Strategic Role of Quality at Suanfarma
    The Strategic Role of Quality at Suanfarma

    31 Jul 2025

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    https://www.suanfarma.com/quality/the-strategic-role-of-quality-at-suanfarma/

    PRESS RELEASE
    31 Jul 2025
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