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45 All APIs, 29 USDMF, 11 EU WC, 4 KDMF, 36 NDC API

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8 FDF Dossiers, 8 South Africa

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1 All Excipients, 1 USDMF

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3 FDA, 1 EDQM, 1 WHO-GMP, 1 GDUFA, 2 Others

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INTERVIEW #SpeakPharma

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“Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

This week, SpeakPharma interviews Marie-Armelle Floc’h, Chief of Quality and Regulatory Affairs at HTL Biotechnology, a global leader in the development and the manufacturing of pharmaceutical-grade biopolymers headquartered in Javené, Brittany (France). Since 1992, HTL has pioneered the production of hyaluronic acid (HA) through proprietary biofermentation, achieving unmatched purity and consistency for applications in ophthalmology, dermatology and rheumatology. Floc’h highlights how HTL Biotechnology’s compelling portfolio of pharmaceutical-grade biopolymers is built on uncompromising quality standards. These standards have enabled the company to supply biopolymers for over 30 years without a single batch recall, firmly establishing its reputation for reliability and excellence. She also discusses the inauguration of HTL Biotechnology’s new sterile hyaluronic acid production unit — a major milestone that reinforces the company’s leadership in biopolymer manufacturing and enables the development of innovative formulations combining hyaluronic acid with thermo-sensitive active ingredients. This new capability opens the door to advanced biomedical applications where safety, stability and efficacy must be preserved without compromising the integrity of delicate molecules and which requires the highest quality standards. What distinguishes HTL Biotechnology’s biopolymer platforms in the market today? HTL Biotechnology has built its reputation on delivering pharmaceutical‑grade biopolymers (hyaluronic acid, polynucleotides and recombinant collagen) with unmatched purity and consistency. Since its founding in 1992, the company has focused on premium quality positioning. With more than 30 years of experience, HTL Biotechnology guarantees pharmaceutical-grade biopolymers of exceptional purity and exemplary consistency to our clients. We have had no batch recalls in 30 years, a record that underlines the rigor and reliability embedded in our processes. This was made possible by our fully-integrated site in France, where R&D laboratories, GMP manufacturing, quality control, and regulatory expertise are brought together under one roof. Such integration allows us to support our clients seamlessly throughout their product development journey, from early innovation through to global commercialization.Also, the inauguration of our new sterile hyaluronic acid production unit expands the possibilities for our HA to be used in advanced formulations with thermo-sensitive active ingredients, while upholding the uncompromising quality that defines HTL Biotechnology.Our operations are guided by internationally recognized standards, including ISO 13485 certification, which ensures the quality and safety required by medical device manufacturers worldwide.In addition, our Halal certification provides our customers with a significant advantage in accessing and expanding into markets where these requirements are essential for commercialization.Beyond certifications, our commitment to supporting global growth is reflected in the Drug Master Files we maintain across five continents, enabling our clients to accelerate product registration and bring innovative therapies to markets across the world more efficiently. By combining craftsmanship with pharmaceutical rigor, supported by state-of-the-art equipment and advanced bio-production methods, we ensure that every batch produced not only meets the strictest standards, but also delivers the reliability and consistency needed across the entire healthcare ecosystem. HIGHLIGHTS// Biopolymers with unmatched purity/record of no batch recalls/integrated facility in France/operations guided by global standards/new sterile HA unit for advanced formulations Navigating the complex and evolving regulatory frameworks across global markets can be challenging for healthcare companies. Can you tell us more about how HTL Biotechnology supports its partners in this area? Regulatory support is part of our core premium services offer. We provide pharmaceutical regulatory support to ensure products meet the necessary compliance standards, so our partners can focus on their growth. Our dedicated regulatory professionals bring global and regional expertise, with a team specifically supporting customers in Asia. We offer personalized assistance adapted to their products and to the compliance standards of the target market. This includes personalized case-management support for regulatory file submissions with the concerned health authorities to minimize risks of refusal or delay, with the aim of achieving approval quickly and smoothly.Our offer for regulatory support continues beyond approval. We continuously monitor updates to regulations and provide post-commercialization support to our partners to help them manage any necessary regulatory updates.HIGHLIGHTS// Regulatory support offered as premium service/global and regional expertise/personalized case management for faster approvals/continuous regulatory support How does HTL Biotechnology integrate sustainability and corporate responsibility into its operations? Sustainability is embedded in HTL Biotechnology’s strategic vision and day-to-day operations. In 2024, the company renewed its commitment to environmental responsibility by reinforcing its corporate social responsibility (CSR) roadmap. Tangible progress was made across multiple fronts: a 27 percent reduction in greenhouse gas emissions per kilogram of HA produced between 2021 and 2024, and a 34 percent reduction in water consumption per kilogram of HA since 2020. In 2024, we renewed the ISO 14001:2015 certification for its environmental management system, reflecting rigorous audit protocols and continual improvement cycles. All employees have been trained in the ISO 14001-certified environmental management system, and 78 percent of critical suppliers have signed HTL Biotechnology’s Responsible Purchasing Charter.These results reflect HTL Biotechnology’s structured and proactive approach to reducing its environmental footprint while maintaining the highest standards of quality and compliance.HIGHLIGHTS// Sustainability embedded in strategic vision/strong CSR roadmap with measurable progress/reduction in greenhouse gas emissions/responsible sourcing

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VLOG #PharmaReel

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Partnering with nature to grow foundational medicines

This PharmaReel showcases Centrient Pharmaceuticals, a global leader in sustainable enzymatic antibiotics, antifungals and next-gen statins, with integrated capabilities across intermediates, APIs & finished dosages, with a vision to be the leading, diversified partner for generics marketers.

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DATA COMPILATION #PharmaFlow

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Top news of 2025: Drugmakers invest in US capacities, agree to lower Medicaid prices; Pfizer buys obesity-focused biotech Metsera

The year 2025 was an eventful one, marked by increased trade tensions, tariff threats, accelerated adoption of artificial intelligence (AI) in drug development, and an intensified race for next-gen obesity treatments. Major drugmakers pledged substantial investments in the US to mitigate potential tariffs. By the year-end, the Trump Administration announced deals with several drugmakers to lower prices for its Medicaid program and for cash payers.The year also saw significant changes at the US Food and Drug Administration (FDA), including high-profile leadership changes and workforce reductions. The agency rolled out advanced AI systems — known as agentic AI — to help its staff achieve specific goals.Several large mergers and acquisitions also shaped 2025. Pfizer bought obesity-focused biopharma Metsera for US$ 10 billion and Johnson & Johnson acquired Intra-Cellular for US$ 14.6 billion. Vertex Pharmaceuticals introduced a new, non-opioid painkiller, Journavx (suzetrigine), and GSK launched Blujepa (gepotidacin) which is now approved for treating uncomplicated urinary tract infections (uUTIs) and gonorrhea. Here are the top stories that made it to PharmaCompass’ top 10 Phispers of 2025.I. Drugmakers pledge over US$ 370 bn in building US capacities; lower Medicaid prices From the outset, 2025 was defined by tariff threats and trade tensions as the US government signaled potential steep tariffs on imported branded drugs. To mitigate the impact of potential tariffs, multinational drugmakers announced sizable investments in the US.Eli Lilly has announced a US$ 27 billion investment, followed by Johnson & Johnson (US$ 55 billion), Novartis (US$ 23 billion), Roche (US$ 50 billion), Bristol Myers Squibb (US$ 40 billion), AstraZeneca (US$ 50 billion), and GSK (US$ 30 billion). A Wall Street Journal report dated September 16 states that drugmakers have pledged more than US$ 370 billion in US investments due to tariff threats, while ThinkGlobalHealth estimates this number at over US$ 480 billion.On September 30, Pfizer struck a US$ 70 billion deal with the US government to lower Medicaid drug prices and expand domestic manufacturing. And in December, US President Donald Trump and nine major drugmakers announced agreements to lower medicine prices for the government’s Medicaid program and for cash payers. These prices will be in line with the lowest prices paid by other developed nations (known as the ‘most-favored-nation’ pricing).II. Pfizer doubles down on obesity market, buys Metsera for US$ 10 bn, inks deal with YaoPharmaPfizer aggressively pursued the booming obesity market. In November, Pfizer completed the US$ 10 billion (approximately) acquisition of Metsera, a clinical-stage biopharma focused on drugs for obesity and cardiometabolic diseases, after winning a bidding war against Novo Nordisk. The following month, Pfizer signed a deal worth up to US$ 2.1 billion with China’s YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical, to develop and commercialize an experimental GLP-1 weight-loss drug — YP05002.III. FDA approves Vertex’s non-opioid painkiller that blocks acute pain at sourceFDA approved Vertex Pharmaceuticals’ non-opioid painkiller, Journavx (suzetrigine), for the treatment of moderate-to-severe acute pain in adults. This represents the first new class of pain medication in over two decades, and offers an alternative to opioid analgesics.IV. GSK’s Blujepa approved for treating uncomplicated UTIs; also okayed for gonorrheaIn March 2025, FDA approved GSK’s antibiotic, Blujepa (gepotidacin), for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older who weigh at least 40 kg. This marked the first approval of a new class of for uUTIs in nearly 30 years. In December, FDA expanded Blujepa’s label to include treatment for gonorrhea, a sexually transmitted disease.V. J&J acquires neuroscience biotech Intra-Cellular for US$ 14.6 billionJohnson & Johnson kicked off 2025 with the US$ 14.6 billion acquisition of Intra-Cellular Therapies, strengthening its neuroscience portfolio. Intra-Cellular’s Caplyta (lumateperone) is a once-daily oral therapy approved for treating adults with schizophrenia and depressive episodes associated with bipolar I or II disorder.VI. Changes at FDA: A year marked by high-profile resignations, rollout of agentic AIFDA experienced significant organizational changes in 2025, including senior leadership departures, amid the Trump administration’s policy shifts. Approximately 3,500 FDA staff were slated for layoffs beginning in April, raising concerns about the agency's review systems. Health and Human Services (HHS) secretary Robert F Kennedy Jr’s anti-vaccine stance led to internal tensions, controversies and departures of senior vaccine officials.The agency is transforming itself — in December, it announced the deployment of agentic AI capabilities for all its employees. Agentic AI refers to advanced AI systems designed to achieve specific goals by planning, reasoning, and executing multi-step actions.VII. Sanofi-Alnylam’s Qfitlia becomes first approved RNAi med for hemophilia A, BFDA approved Qfitlia (fitusiran) — the first RNA interface (RNAi) therapeutic for treating rare bleeding disorders hemophilia A and B. Developed through a collaboration between Sanofi and Alnylam Pharmaceuticals, Qfitlia is indicated for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia patients aged 12 and older.VIII. Astra-Daiichi Sankyo’s Datroway bags FDA nod for treating advanced lung, breast cancerAstraZeneca and Daiichi Sankyo’s precision drug Datroway (datopotamab deruxtecan) won two key approvals in 2025. In January, Datroway received FDA approval for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. And in June, it bagged accelerated approval for the treatment of an advanced form of non-small cell lung cancer in adults who had received prior treatment.IX. Novartis continues to forge deals; inks US$ 12 bn deal with Avidity, US$ 2 bn deal with Arrowhead Following active deal-making in 2024, Novartis continued to make strategic acquisitions in 2025. It acquired US-based Avidity Biosciences for approximately US$ 12 billion to expand its rare muscle disorders portfolio. As part of the deal, Avidity will spin off its early-stage cardiology drug programs into a new publicly-traded company called SpinCo.Novartis also signed a licensing and options deal with China-based Argo Biopharmaceuticals worth up to US$ 5.2 billion for experimental cardiovascular drug candidates, and a US$ 2 billion licensing and collaboration agreement with Arrowhead Pharmaceuticals for its preclinical neurodegenerative disease candidate. Novartis also agreed to buy Anthos Therapeutics, a drug development company majority-owned by investment firm Blackstone, for up to US$ 3.1 billion.X. Merck acquires Verona for US$ 10 billion; inks US$ 9.2 billion deal to buy CidaraMerck acquired London‑based Verona Pharma for approximately US$ 10 billion as part of its strategy to diversify ahead of the 2028 patent expiration of its cancer blockbuster, Keytruda (pembrolizumab). Merck also agreed to acquire Cidara Therapeutics in a deal valued at approximately US$ 9.2 billion, strengthening its infectious disease portfolio.

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Apothecon Pharmaceuticals is a supplier offers 39 products (APIs, Excipients or Intermediates).

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