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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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We are a Global Company

This PharmaReel showcases Capital Farma’s comprehensive range of pharmaceutical solutions, including GMP-certified APIs from leading manufacturers. They deliver complete product packages with FDF dossiers and offer licensing services to help clients expand their market reach and grow sales.

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DATA COMPILATION #PharmaFlow

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Antibiotic market to reach US$ 74.07 billion by 2033; FDA approves GSK’s Blujepa for uncomplicated UTIs

The global market for antibiotics has been witnessing several challenges. First, there is growing recognition of the harm overuse and misuse of antibiotics can do to human health. Antimicrobial resistance (AMR) is considered a silent and rapidly growing pandemic.Second, inadequate treatment of pharmaceutical wastewater poses significant environmental risks and contributes to rising AMR. This has led to higher expectations and regulations around sustainable and compliant manufacturing. Third, we are witnessing increased guidelines around the use of certain antibiotics, such as the use of fluoroquinolones.And fourth, supply chain issues have taken centerstage post Covid, as much of APIs used in manufacturing antibiotics come from China and India. This structural vulnerability is reshaping procurement strategies around the world.Despite these headwinds, antibiotics remain indispensable to public health, and their demand is growing at a healthy pace. According to Grand View Research, the global antibiotics market is set to reach US$ 74.07 billion by 2033, growing at a compound annual rate of 3.71 percent from 2025 to 2033.Major players in the antibiotics space include Pfizer, GSK, Centrient Pharmaceuticals, Merck & Co, Abbott Laboratories, Bristol-Myers Squibb, Century Pharmaceuticals, Teva Pharmaceutical Industries, Sun Pharmaceutical Industries, Hisun Pharmaceutical, Aurobindo Pharma, Novartis AG, and Sanofi. Players like Lupin Limited, Dr Reddy’s Laboratories, Cipla, Fresenius Kabi are known for their cost-efficient generics and specialized formulations.FDA approves GSK’s Blujepa for uncomplicated UTIs, Pfizer-AbbVie’s Emblaveo for intra-abdominal infectionsThis year, two new antibiotics bagged the approval of the US Food and Drug Administration (FDA).In February this year, FDA approved Emblaveo (aztreonam and avibactam), developed jointly by AbbVie and Pfizer, for the treatment of complicated intra-abdominal infections in adults who have limited or no alternative treatment options. Emblaveo is the first and only fixed-dose, intravenous, combination antibiotic. It is approved in combination with metronidazole for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections, including those caused by escherichia coli, klebsiella pneumoniae, klebsiella oxytoca, enterobacter cloacae complex, citrobacter freundii complex, and serratia marcescens. The European Commission granted marketing authorization to Emblaveo in April 2024.Another notable approval was granted to GSK’s Blujepa (gepotidacin). It was approved by the FDA in March this year for treating uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years and older. This marks the first approval of a new class of oral antibiotics for uUTIs in nearly 30 years. Blujepa’s dual-action approach drastically reduces the likelihood of developing AMR. The drug was approved in the UK in August.This month, FDA accepted Wockhardt’s new drug application (NDA) for its antibiotic Zaynich (a combination of cefepime and zidebactam) under its fast track approvals pathway. This is the first NDA for a new chemical entity filed by an Indian drugmaker that has been accepted by the FDA. Zaynich is developed for treating multi drug-resistant infections. Wockhardt has said the market opportunity could be worth up to US$ 7 billion.GSK shutters Ulverston site in UK; EU Council agrees on Critical Medicines Act to strengthen supply chainThe Covid-19 pandemic had exposed deep-seated weaknesses in antibiotic supply chains across the US and Europe. In July 2020, when supply chain disruptions were at their peak, Austria had teamed up with Novartis to strengthen antibiotic manufacturing. Sandoz, Novartis’ generic unit, and the Austrian government had agreed to invest €150 million (US$ 175 million) over five years to improve antibiotic manufacturing at Novartis’ plant in Kundl, Austria.In March 2024, Sandoz inaugurated a new automated production facility increasing its antibiotic production capacity by 20 percent. However, in a recent report, Richard Saynor, CEO of Sandoz, warned that the “last remaining 6-APA manufacturing site in any European or North American country – operated by Sandoz in Kundl, Austria – faces an increasingly precarious economic situation, which has worsened significantly in recent years due to a series of major geopolitical shocks.”The UK is facing similar challenges. In June, GSK confirmed the closure of its Ulverston site, the country’s last major antibiotic fermentation facility. The site, which began operations over 75 years ago, had been producing the antibiotic Zinnat (cefuroxime axetil) for Sandoz. The contract ended earlier this year, and GSK plans to demolish the antibiotic factory.In March, the European Commission had proposed a framework to secure the availability of critical medicines. The Council of the European Union has now agreed on the Critical Medicines Act, aimed at strengthening the EU's supply of essential medicines, including antibiotics, insulin and painkillers, by improving security of supply and availability in the EU.Lyfius Pharma, Boryung set up penicillin manufacturing facilities; Centrient earns second AMR-risk certificationDrug shortages have prompted companies across the world to increase capacities. South Korea’s Boryung Pharmaceutical is setting up an oral penicillin antibiotic production facility in Ansan (South Korea). Once completed, this facility will more than double the annual production of oral penicillin capacity. More than 60 percent of global penicillin API capacity and over 80 percent of penicillin intermediate production remain concentrated in China. Similarly, in cephalosporins (antibiotics that inhibit bacterial cell wall synthesis), only two intermediate-production sites operate worldwide, one of them being Centrient’s facility in the Netherlands. The other one is in China. Headquartered in the Netherlands, Centrient Pharmaceuticals is a global B2B leader in sustainable, enzymatic antibiotics, next-generation statins and antifungals. The company recently secured its second independent Minimized Risk of AMR certification for its antibiotic production. Only four other manufacturers have AMR certification in Europe.The US currently has no domestic antibiotic API production facility, and is relying heavily on APIs imported from China and finished dosage forms from India.In March this year, US-based specialty drugmaker Avenacy launched a suite of five antibiotic products — ampicillin for injection, ampicillin and sulbactam for injection, nafcillin for injection, penicillin G potassium for injection, piperacillin and tazobactam for injection.In India, Syschem is setting up a new factory to manufacture cloxacillin, dicloxacillin, and flucloxacillin sodium. It is also expanding its existing amoxicillin unit. The total investment is estimated to be around Rs 150 to Rs 200 million (US$ 1.67 million to US$ 2.22 million).Similarly, Lyfius Pharma is investing Rs 25 billion (US$ 278 million) through the Indian government’s Production Linked Incentive Scheme for its state-of-the-art penicillin-G manufacturing facility, at Kakinada, Andhra Pradesh.Our viewThe market for antibiotics is navigating a complex mix of AMR risks, supply chain vulnerabilities and cost pressures. The approval of GSK’s Blujepa signals scientific progress. But a lot more needs to be done to build resilient supply chains, and to address the rising menace of AMR.

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Wisdom Pharmaceutical is a supplier offers 45 products (APIs, Excipients or Intermediates).

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