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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.https://marketing.lgmpharma.com/LGM-CDMO

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    Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “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.

    Impressions: 41

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    https://www.pharmacompass.com/speak-pharma/we-are-exploring-and-piloting-ai-as-part-of-our-strategic-it-roadmap-to-enhance-decision-making-and-streamline-operations

    PharmaCompass
    24 Feb 2026
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaExpertise in Particle Size EngineeringExpertise in Particle Size Engineering

    Expertise in Particle Size Engineering
    Expertise in Particle Size Engineering

    reelExpertise 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: 250

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).  Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.
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    Impressions: 1825

    https://www.pharmacompass.com/radio-compass-blog/fda-s-december-2025-opoe-list-features-784-prescription-drugs-73-otc-drugs

    #PharmaFlow by PHARMACOMPASS
    22 Jan 2026
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    NEWS #PharmaBuzz

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    Kyowa Hakko Bio Co., Ltd. on Health Canada Inspection List
    Kyowa Hakko Bio Co., Ltd. on Health Canada Inspection List

    17 Apr 2023

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/kyowa-hakko-bio-co-ltd-on-health-canada-inspection-list-9449.pdf

    HEALTH CANADA
    17 Apr 2023
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    Kyowa Hakko Acclaimed by Frost & Sullivan for its IMMUSE
    Kyowa Hakko Acclaimed by Frost & Sullivan for its IMMUSE

    21 Sep 2021

    // PRNEWSWIRE

    https://www.prnewswire.com/news-releases/kyowa-hakko-acclaimed-by-frost--sullivan-for-its-non-gmo-allergen-free-immune-support-paraprobiotic-ingredient-immuse-301379881.html

    PRNEWSWIRE
    21 Sep 2021
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    MEI Pharma & Kyowa Kirin Announce 1st Patient with Marginal Zone Lymphoma Dosed
    MEI Pharma & Kyowa Kirin Announce 1st Patient with Marginal Zone Lymphoma Dosed

    07 Jun 2021

    // PRNEWSWIRE

    https://www.prnewswire.com/news-releases/mei-pharma-and-kyowa-kirin-announce-first-patient-with-marginal-zone-lymphoma-dosed-in-expanded-global-phase-2-tidal-study-evaluating-zandelisib-301306621.html

    PRNEWSWIRE
    07 Jun 2021
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    Japan's Kyowa Kirin reorganizes quality responsibilities
    Japan's Kyowa Kirin reorganizes quality responsibilities

    26 Nov 2019

    // Eric Palmer FIERCE PHARMA

    https://www.fiercepharma.com/manufacturing/japan-s-kyowa-kirin-reorganizes-quality-responsibilities

    Eric Palmer FIERCE PHARMA
    26 Nov 2019
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    Kyowa Hakko Bio on Health Canada Inspection List
    Kyowa Hakko Bio on Health Canada Inspection List

    17 Nov 2018

    // HEALTH CANADA

    https://www.pharmacompass.com/pdf/news/kyowa-hakko-bio-on-health-canada-inspection-list-1542450249.pdf

    HEALTH CANADA
    17 Nov 2018
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    EU approves fifth copy of AbbVie's $18 billion drug Humira
    EU approves fifth copy of AbbVie's $18 billion drug Humira

    21 Sep 2018

    // Ben Hirschler REUTERS

    https://www.reuters.com/article/us-abbvie-biosimilars/eu-approves-fifth-copy-of-abbvies-18-billion-drug-humira-idUSKCN1M011N

    Ben Hirschler REUTERS
    21 Sep 2018
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