Fresenius SE & Co. KGaA DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 12 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
12 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

156 All APIs, 67 USDMF, 52 CEP/COS, 5 JDMF, 32 EU WC, 23 KDMF, 26 NDC API, 1 VMF, 2 Listed APIs

156 All APIs
67 USDMF
52 CEP/COS
5 JDMF
32 EU WC
23 KDMF
26 NDC API
1 VMF
2 Listed APIs

DEVELOPMENTS

97 Drugs in Development

97 Drugs in Development

FINISHED DOSAGE FORMULATIONS

4364 FDF Dossiers, 622 FDA Orange Book, 711 Europe, 415 Canada, 3 Australia, 2613 South Africa

4364 FDF Dossiers
622 FDA Orange Book
711 Europe
415 Canada
3 Australia
2613 South Africa

SERVICES

Analytical

pharmaServices
Analytical
- 1 Stability Studies
- 1 Analytical Method Development

EXCIPIENTS

1 All Excipients, 1 USDMF

excipientPortfolio
1 All Excipients
1 USDMF

REF. STANDARDS & IMPURITIES

1 Others

otherProducts
1 Others

INSPECTIONS & REGISTRATIONS

59 FDA, 4 EDQM, 4 WHO-GMP, 13 GDUFA

inspections
59 FDA
4 EDQM
4 WHO-GMP
13 GDUFA

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

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About

Fresenius is a global health care group with products and services for dialysis, the hospital and the medical care of patients at home. The Fresenius Group consists of the following four business segments that are responsible for their own business operations worldwide: Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed.

CPhI WW FrankfurtCPhI WW Frankfurt

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28-30 October, 2025

Frankfurt
Fall Technical MeetingFall Technical Meeting

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05-07 October, 2025

Boston, MA
The MedTech ConferenceThe MedTech Conference

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05-08 October, 2025

San Diego, USA

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CONTACT DETAILS

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Country

Germany

Address

Else-Kröner-Str. 1 61352 Bad Homburg

Telephone

+49 6172 608-0

enquiries@pharmacompass.com

Website

https://www.fresenius.com/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“We bridge the gap between chemistry and performance to deliver precise, optimized micronization for complex APIs.”

This week, SpeakPharma interviews Stefano Martinoli, Chief Executive Officer of Munit SA, a Swiss company that specializes in micronization of active pharmaceutical ingredients (APIs) and other pharmaceutical compounds. Stefano Martinoli discusses Munit’s 60-year legacy, how micronization of APIs has improved therapeutic effects of drugs, and how the group is today a partner in drug development for its more than 150 global customers. He says innovation is a mindset at Munit, which is rooted in adaptability, foresight, and a deep culture of problem-solving. Could you share Munit SA’s journey over the past 60 years and explain how you’ve built such a strong global presence with over 150 customers? Munit’s story is one of innovation and vision. Our entrepreneurial journey began in 1918, rooted in powder handling and particle size engineering. The real breakthrough came in the 1960s, when my father pioneered the Spiral Jet Mill technology. In 1962, at the age of 24, he designed the first Spiral Jet Mill, placing us at the forefront of a field that would later revolutionize pharmaceuticals. Initially, this technology served the fine chemical industry, but in the early 1970s my father foresaw its immense potential for healthcare. He realized that micronization, or the mechanical reduction of particle size of APIs, could directly improve patients’ lives by enhancing APIs’ solubility. Better solubility means faster therapeutic effects and fewer side effects, which are critical advances for patient well-being. Founded in 1978, Microchem pioneered contract micronization in Italy before expanding into Switzerland to better serve global markets. In the late 1990s, we were the first in our field to introduce glove-box isolators for highly potent APIs, setting new safety standards. Today, under the Munit umbrella, Jetpharma (Switzerland) and Microchem (Italy) operate together, offering clients dual-site reliability that reduces supply chain risks and ensures business continuity. Over the decades, this vision has guided us to become more than just a service provider: we are partners in drug development. What sets us apart is our dual expertise, both in the technology itself and in the science of micronization. We don’t just operate equipment; we adapt it to the unique properties of each API, customizing processes and technological solutions to achieve the highest-quality outcomes. Today, with more than 150 global customers and six decades of proven excellence, Munit is recognized as a pioneer and a leader in pharmaceutical micronization. Our best-in-class processes, unmatched flexibility, and unrivaled expertise make us the go-to partner for companies that demand innovation, reliability, and speed in bringing their therapies to market. HIGHLIGHTS// Story of innovation/micronization and better solubility/faster therapeutic effects/fewer side effects/advancement in patient wellbeing/partners in drug development How does Munit foster innovation in micronization and particle engineering to stay ahead of evolving pharmaceutical needs? For Munit, innovation goes far beyond simply maintaining technological leadership — it’s about anticipating what’s next and shaping solutions that meet tomorrow’s pharmaceutical needs. Innovation, to us, is not just about machines or methods; it’s a mindset rooted in adaptability, foresight, and a deep culture of problem-solving. The pharmaceutical environment is constantly evolving: increasing molecular complexity, stricter regulations, and ever-higher patient expectations. To stay ahead, we focus on three pillars, responsiveness, vision, and precision. We respond rapidly to new challenges, forecast future trends to prepare our partners for what’s coming, and align seamlessly with regulatory shifts. At the heart of our work is one simple mission: solving complex solubility challenges to enhance the bioavailability of APIs and ultimately improve patient outcomes. Positioned between API synthesis and final drug formulation, our role in the value chain is critical, ensuring that promising molecules become effective, reliable medicines. What makes Munit different is that we don’t just provide technology; we deliver confidence. With decades of proven expertise, we give pharmaceutical companies what they need most: a reliable, long-term partner who can guarantee performance, consistency, and speed in the most demanding projects. HIGHLIGHTS// Shaping solutions that meet tomorrow’s needs/innovation mindset/focus on responsiveness, vision, precision/reliable long-term partners How does Munit ensure high-performance service delivery to its pharmaceutical clients? At Munit, delivering high-performance service means going beyond technical proficiency — we ensure our clients achieve faster, safer, and more reliable results. Every project has its own challenges, and our strength lies in anticipating them and adapting with agility. This ability to align with client needs (whether in early-stage R&D or commercial-scale production) is what makes us a long-term partner in the pharmaceutical value chain. Our teams bring decades of experience and specialized expertise that translate into concrete benefits for our clients: faster project turnaround, consistent compliance with global regulatory standards, and reduced risks across the supply chain. By combining deep process knowledge with flexibility, we help pharmaceutical companies accelerate time-to-market while safeguarding quality and repeatability. As a family-owned business, our culture of trust and long-term commitment drives everything we do. This foundation allows us to guarantee continuity, responsiveness, and the reliability that global pharma companies require in their strategic partners. Simply put: with Munit, clients know their projects are in expert hands, from grams to tons, from R&D to commercialization. HIGHLIGHTS// Going beyond technical proficiency/experience, expertise translate into benefits for clients/accelerate time to market How does Munit leverage its advanced milling technologies to support customers in achieving optimal particle size and consistency, especially for complex APIs? Munit holds a unique position in the market because we know how to adapt, refine, and customize processes to the exact needs of each API. Decades of experience across hundreds of molecules have allowed us to fine-tune our technology and ensure optimal efficiency, reproducibility, and scalability for our clients. This expertise is especially critical when dealing with complex APIs. Pharmaceutical companies typically know the chemical properties of their compounds, but once those materials are transformed into powders, their physical behavior becomes a real challenge. That’s where Munit steps in. Our specialized know-how bridges this gap, ensuring particle size and consistency are precisely controlled, directly impacting solubility, bioavailability, and ultimately patient outcomes. By combining scientific insight, technical know-how, and a quality-by-design mindset, we give our clients confidence that every process is optimized for efficiency, reliability, and patient benefit. HIGHLIGHTS// Customize process to needs of each API/dealing with complex APIs/combining science with technical knowhow/quality-by-design mindset With operations in both Switzerland and Italy, how do Munit’s dual sites contribute to reducing supply chain risk, lead times, or overall costs for clients? Our dual sites in Switzerland and Italy give Munit a unique edge in supply chain resilience, flexibility, and cost efficiency. Recent investments — tripling Microchem’s footprint and expanding Jetpharma’s GMP warehouse capacity — enable us to handle growing demand while keeping lead times competitive. But infrastructure alone is not enough. By harmonizing quality systems, aligning operational standards, and driving a tailored digital transformation, we ensure that even the most complex APIs are managed with the highest reliability and efficiency. This integration across sites allows us to deliver the lean, responsive manufacturing that major pharma partners expect, while reducing risks and strengthening long-term partnerships. HIGHLIGHTS// Supply chain resilience comes from dual sites/managing complex APIs with reliability, efficiency/long-term partnerships

Impressions: 1660

VLOG #PharmaReel

[Sponsored by another company]

Partner in End-to-End API Manufacturing

This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

Impressions: 1620

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

Precise particle size control has become the cornerstone of modern pharmaceutical manufacturing. With highly potent active pharmaceutical ingredients (HPAPIs) and complex formulations driving unprecedented demand, micronization technology is no longer optional — it's critical. The market reflects this urgency. The global API micronization market will jump from US$ 2.47 billion in 2024 to US$ 3.68 billion by 2030 — a 49 percent surge driven by a robust 6.84 percent CAGR. What's powering this growth? Strategic innovation by industry leaders. Companies like Munit SA, Lonza, Catalent, Veranova, EUROAPI, AGC Pharma Chemicals, Hovione and Coral Drugs aren't just participating — they're defining the future of pharmaceutical particle engineering. The Micronization Landscape: How leading companies are advancing pharmaceutical particle engineering The API micronization space is being shaped by companies with specialized expertise. Munit’s proprietary fluid jet milling technology brings particle sizes down to the 1-micron level — critical for inhalation therapies. In addition, this technology enables precise control over particle size distribution without mechanical impact, making it ideal for heat-sensitive and high-potency APIs. With decades of hands-on experience, Munit ensures batch-to-batch consistency, scalability from R&D to commercial volumes, and full compliance with GMP standards. Munit offers high-containment isolators — including glove boxes for R&D and half-suit isolators for larger batches — with industry-leading containment levels, limiting airborne drug exposure to as low as 0.025 micrograms per cubic meter. This makes it particularly well-suited for handling highly potent or sensitive compounds, exceeding the capabilities of other commercial-scale players like Catalent, who typically achieve containment levels of 0.05 micrograms per cubic meter or higher. EUROAPI has taken a broad particle engineering approach, offering both micronization and spray drying across multiple dosage routes — oral, inhaled, and parenteral. AGC Pharma Chemical leverages spray drying and amorphous solid dispersion technologies across small molecules, peptides, ADCs, and oligonucleotides, exemplifying the evolving intersection of particle engineering and modern drug delivery innovation. Coral Drugs delivers cutting-edge technology and customization capabilities that tailor particle sizes to specific client requirements across tablets, injectables, and topicals. This dynamic competitive landscape continues to evolve as companies expand capabilities and form strategic partnerships. This year, Dec Group announced the launch of their cutting-edge Micronization Suite, now operational in Brick, New Jersey, while Lonza joined the Centre for Continuous Manufacturing and Advanced Crystallisation, an international research hub, to develop innovative continuous processing and crystallization solutions. Selecting the right micronization partner: Key success factors In a pharmaceutical landscape increasingly defined by complexity, precision, and speed-to-market, the choice of a micronization partner can significantly influence a drug’s success. Among the players in this space, Munit SA has emerged as a trusted and strategic ally for pharmaceutical companies worldwide. But what exactly sets Munit apart in the micronization market? To begin with, Munit SA brings over 60 years of experience in particle size engineering. This legacy is not just a number; it reflects decades of accumulated knowledge, process refinement, and a deep understanding of how particle size impacts drug performance. In an industry where even minor deviations can compromise efficacy or safety, this level of experience is invaluable. It has delivered over 500 successful micronization projects to more than 150 customers globally. At its core, Munit SA is laser-focused on micronization and milling — not as ancillary services, but as its primary mission. Their facilities are designed for processing high-potency APIs, cytotoxic and cytostatic compounds, non-beta-lactam antibiotics, steroids, and controlled substances under stringent containment protocols. The company also handles inhalation products, peptides, biological drugs, generics, and R&D compounds. Whether it's micronization for ophthalmic formulations, transdermal or oral products, Munit offers a tailored approach. It stands as a world-leading provider of micronization services in inhalation powders with particle sizes of 1-5 microns and specialized oncology applications for small molecules. In an increasingly complex global landscape, Munit SA addresses supply chain challenges through its dual-site operational model, with facilities in Switzerland (Jetpharma SA) and Italy (Microchem S.r.l). This strategic setup mitigates risks from regulatory changes, geopolitical tensions, or environmental disruptions, ensuring continuous production and delivery of critical APIs. This resilience makes Munit a trusted partner for companies prioritizing business continuity. Why pharmaceutical companies choose Munit for advanced micronization and milling Munit’s proprietary MC Jet Mill is a testament to its engineering excellence. For heat-sensitive APIs, Munit’s cryogenic micronization process uses liquid nitrogen to cool materials, preventing thermal degradation and preserving the integrity of delicate molecules. This is particularly valuable for biologics and APIs with low melting points, where stability is paramount. Additionally, Munit’s under containment micronization employs advanced systems to safely handle HPAPIs, protecting both operators and the environment while meeting stringent regulatory standards. Their co-micronization service, which processes APIs alongside excipients, further enhances formulation stability and solubility, offering innovative solutions for complex drug profiles. These capabilities, executed under Good Manufacturing Practices (GMP), make Munit a reliable choice for pharmaceutical companies seeking precision and quality. While micronization is Munit’s flagship, it offers milling services through an array of technologies, each suited to specific needs. The Pin Mill uses a grinding chamber and particle size reduction is achieved due impact against a high-speed pin rotor, producing sizes from 50 to 150 microns. It’s particularly effective for APIs needing improved flow for tableting, offering precise size control that ensures uniformity. The Quadro Co-Mill excels at soft de-lumping and homogenization, using a conical sieve and impeller to gently process powders without altering primary particle sizes. For tougher materials, the HammerMill C-10 employs hammer bars on a rotor to crush particles. State-of-the-Art Particle Engineering: Munit's strategic innovation push delivers next-gen solutions Munit’s leadership in micronization is underpinned by a deliberate and sustained investment in innovation — aimed at building the next generation of particle size engineering. In response to client challenges with condensation and product degradation, Munit developed a proprietary conditioning system that precisely controls humidity and temperature. Engineered with ergonomic design and fluid dynamics principles, their machine represents a qualitative leap in conditioning. Munit's new AIFA-approved Building C transforms the Italian hub's capacity. Equipped for high potent, toxic, cytotoxic, and cytostatic compounds, alongside hormones, it features cutting-edge safety systems and integrated technologies, enabling broader API processing with precision and compliance. Munit has merged quality assurance and regulatory affairs into one strategic unit, streamlining workflows and enhancing client responsiveness during critical validation phases. This delivers tailored regulatory support and accelerates time-to-market. These initiatives position Munit at the forefront of particle size engineering, where state-of-the-art innovation, regulatory excellence, and client-centric design converge to set new industry standards. Our view The API micronization market is projected to grow 49 percent to US$ 3.68 billion by 2030. In this evolving landscape, companies that combine deep technical expertise with operational resilience are positioned to capture the greatest value. Munit SA exemplifies this winning formula.