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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 86 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
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DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 29 FDA Orange Book, 12 Australia

41 FDF Dossiers
29 FDA Orange Book
12 Australia

INSPECTIONS & REGISTRATIONS

1 FDA

inspections
1 FDA

Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

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About

Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company that develops and manufactures branded and generic products, which it distributes directly or through distribution partners and also provides contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems for both generic and proprietary applications including: Lozanoc® – super-bioavailable itraconazole used to treat fungal infections. Doryx® – delayed-release oral formulation of doxycycline used to treat acne, certain bacterial infections or as an anti-malarial Astrix® – delayed-release low-dose aspirin used to treat cardiovascular disease Eryc® – delayed-release erythromycin used in the treatment of bacterial infections Kadian®/Kapanol® – sustained-release oral morphine used in the management of chronic pain A technology driven company, Mayne Pharma has a significant product portfolio and pipeline, global reach through distribution partners in Australia, USA, Europe and Asia and two manufacturing facilities based in Salisbury, South Australia and Greenville, North Carolina, USA. The12,000m2 facility in Salisbury, South Australia is capable of developing products from formulation and clinical trial stages to validation and registration, right through to commercial scale manufacture of packaged goods. The drug development and manufacturing operations are supported by approximately 160 staff with 20 formulation and analytical scientists dedicated to the development of new products. The Mayne Pharma site: Is GMP compliant as certified by chief regulatory authorities (FDA, TGA and with mutual recognition from the MHRA, TPD and various Asian regulatory authorities). Is licensed to handle CII/S8 compounds (controlled drug substances) and utilise chlorinated solvents and alcohols in the manufacturing process. Includes an established manufacturing facility with capacity to produce 2.5 billion capsules and tablets, 100 ton of bulk product and 16 million units of liquid and cream product annually. Includes extensive product development laboratory space to accommodate all analytical processes and bench scale formulation through to pilot scale manufacturing and scale-up for multiple concurrent development projects. Is a centre for product development activities, from formulation and clinical trial stage, to validation and registration, to commercial scale manufacture of packaged goods ready to be dispensed. Metrics, Inc. (Metrics) a fully owned subsidiary occupies a state of the art 9,200m2 facility in Greenville, North Carolina. Metrics is a full-service contract development and manufacturing organization (CDMO) specializing in oral dosage forms. The Greenville site has approximately 300 employees with more than 150 analytical and formulation scientists and technicians dedicated to proprietary product pipeline and third party services. The Greenville site: Offers quality pharmaceutical formulation development, analytical testing services and commercial and CTM manufacturing for Phase I – III Offers particular expertise in First-Time-In-Man (FTIM) and Phase I, II, and III Clinical Trial Manufacturing (CTM) – conducting more than 130 FTIM projects for different chemical entities while concurrently developing more than 700 CTM batches. Is GMP compliant with 5 analytical laboratories and 7 large scale manufacturing and packaging suites. Is capable of handling potent and cytotoxic products and are DEA-approved for Schedule II-V controlled substances. Globally, the business provides a broad spectrum of contract services to support investigational new drug (IND), new drug (NDA) and abbreviated new drug (ANDA) submissions to regulatory agencies.

CPhI ChinaCPhI China

Not Confirmed

Not Confirmed

24-26 June, 2025

SNIEC, Shanghai, China
IOPCIOPC

Not Confirmed

Not Confirmed

09-11 June, 2025

Prague
Annual Outsourcing in ...Annual Outsourcing in CT

Not Confirmed

Not Confirmed

10-11 June, 2025

Park Lane, UK

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CONTACT DETAILS

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Country

Australia

Address

1538 Main North Road, Salisbury South, SA 5106

Telephone

+61 8 8209 2666

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Website

https://www.maynepharma.com/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 1144

VLOG #PharmaReel

[Sponsored by another company]

Your Biologic Therapeutic Stabilization, Protection & Delivery Partner

This PharmaReel highlights Pfanstiehl's portfolio, featuring highest-purity, low-endotoxin injectable-grade excipients, generic APIs and intermediates, HPAPIs, and modified carbohydrates. The company provides API custom synthesis and ADC linker manufacturing services, all backed by USFDA certification.

Impressions: 453

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

Excipient Market Overview: Roquette announces restructuring post IFF Pharma buyout; WHO, FDA advance regulatory frameworks

The pharmaceutical excipients market saw significant strategic consolidations, technological developments, and regulatory adaptations in 2025. Globally, the pharmaceutical excipients sector is growing at a compound annual growth rate of 6.6 percent, and was valued at US$ 8.85 billion in 2024. It is projected to reach US$ 14.77 billion by 2032.This year, the sector is witnessing technological advancements, regulatory evolution, and strategic business realignments. North America continues to dominate the global excipients landscape, with a 39.8 percent market share. The Asia-Pacific region is the fastest-growing segment with a substantial 30.4 percent market share, driven by increasing investments in pharmaceutical manufacturing, growing demand for cost-effective drugs, and rising healthcare expenditure across developing economies.Major excipient providers include BASF, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, DuPont, Evonik, Seqens, Actylis, SPI Pharma, PMC Isochem, Croda International, Pfanstiehl, Kewpie Corporation, Boai NKY Pharmaceuticals, ICE Pharma, Roquette, Nanjing Well Pharmaceutical, Minakem, Ashland Global, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Roquette restructures after buying IFF Pharma; Colorcon partners ASHA CelluloseIn May, Roquette completed its acquisition of IFF Pharma Solutions. Valued at up to US$ 2.85 billion in enterprise value, this transaction represents a major consolidation in the pharmaceutical excipients market. The acquisition significantly enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide. Roquette announced a comprehensive, new organizational structure following the acquisition, indicating the company’s commitment to integrate IFF Pharma Solutions’ capabilities seamlessly into its existing operations. This consolidation creates a more robust platform for addressing the growing demand for specialized excipients in complex drug formulations, particularly as the industry moves towards more personalized approaches to medicines.So far, the year has also witnessed some strategic alliances, such as Colorcon’s partnership with ASHA Cellulose. As part of the deal, Colorcon will become the exclusive representative for two ASHA products — ASHACEL and ASHAKOTE — throughout Europe, the Middle East, Africa, Northeast Asia and Southeast Asia.Brenntag Specialties has announced an exclusive distribution agreement with MEGGLE Excipients to expand market reach. This collaboration makes available a broad portfolio of over 30 high-quality lactose-based excipients for various applications in the pharmaceutical industries across the Netherlands, Belgium, Norway, Finland, and Sweden.The portfolio’s versatility offers optimal solutions for a wide range of pharmaceutical applications, including tableting through both granulation and direct compression, powder preparations, and dry powder inhalation. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)WHO, FDA drive new standards with GMP guidelines; Pfanstiehl launches injectable-grade glycineIn March, the World Health Organization had put out a publication titled “Good Manufacturing Practices for Excipients used in Pharmaceutical Products.” WHO’s excipient GMP guideline emphasizes modern quality management principles, comprehensive risk assessment protocols, and supplier qualification procedures for excipients across all stages of production, storage, and distribution.Meanwhile, the US Food and Drug Administration (FDA) has proposed amendments to the Food, Drug, and Cosmetic Act as part of its FY 2025 legislative proposals, specifically targeting supply chain transparency for high-risk excipients. The FDA proposal would require certain excipients designated as high-risk to carry labeling that identifies the original manufacturer’s name and address. This initiative addresses what FDA has identified as a lack of transparency in excipient supply chains.In April, IFF Pharma Solutions launched Low Nitrite METHOCEL hydroxypropyl methylcellulose (HPMC). This innovative product is specifically designed to reduce the risk of nitrosamine formation in finished pharmaceutical dosages, addressing one of the most pressing concerns in contemporary pharmaceutical manufacturing.Pfanstiehl, a global leader in high-purity excipient manufacturing, announced the launch of its High Purity Low Endotoxin Low Metals (HPLE-LM) injectable-grade glycine. This multi-compendial glycine is specifically engineered for use in biologics, vaccines, and the downstream purification of monoclonal antibodies (mAbs). Manufactured under ICH-Q7 cGMP regulations at Pfanstiehl’s advanced facility in Waukegan, Illinois, the product meets stringent global pharmacopeial standards. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Shin-Etsu Chemical invests in Japan, Germany to expand cellulose productionIn March, Shin-Etsu Chemical announced investments in pharmaceutical cellulose business operations in Japan and Europe, thereby showing significant commitment to market expansion. The company is making substantial investments at two key bases: the subsidiary SE Tylose GmbH in Germany, and the Naoetsu Plant in Joetsu, Japan. In Germany, a new production facility for the pharmaceutical excipient L-HPC will be built adjacent to the existing facility, creating a dual base with the Naoetsu Plant. The excipients market in 2025 has seen innovation in functional applications. Research on BENEO’s Palatinose as a bedtime drink shows that it improves aspects of sleep and represents an innovative approach to excipient functionality. Palatinose is a naturally sourced, smart carbohydrate that provides full carbohydrate energy in a more balanced way, thanks to its low-glycemic profile.Gangwal Healthcare, with its EXCiPACT-certified GMP facilities and a robust portfolio of co-processed excipients like ProBlend, Starlose, and Microlose, is actively contributing to the pharmaceutical industry’s demand for functional excipients. The company also offers cellulose-based excipients such as Solvostar (Sodium Starch Glycolate) and Sallyso (Croscarmellose Sodium), designed to improve tablet disintegration and drug release profiles in oral solid dosage forms.Evonik announced a partnership with South Korea–based CDMO ST Pharm to expand its RNA and nucleic acid delivery services. This collaboration enables Evonik to integrate customized nucleic acids from ST Pharm seamlessly with its lipid and lipid nanoparticle (LNP) development and fill-and-finish services. This streamlined approach means that pharmaceutical companies can reduce complexity and increase speed-to-market for nucleic acid therapeutics. View Our Dashboard on Major Excipient Companies in 2025 (Free Excel Available)Our viewThe pharmaceutical excipients market in 2025 is being shaped by several key trends including the development of multifunctional excipients that can simultaneously improve solubility, bioavailability, and control drug release in increasingly complex formulations.Moreover, the expanding generic medicines market is creating demand for cost-effective, versatile excipients. The growing importance of biologics and biosimilars is driving innovation in specialized excipients designed to maintain the stability and efficacy of these complex therapeutic products throughout their lifecycle. And nanotechnology continues to enable advanced nano-excipients for enhanced drug delivery and efficacy.In addition to these trends, we also notice a shift towards natural and plant-based excipients that is driven by sustainability concerns and potential biocompatibility benefits.