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    Company profile for Olon S.p.A

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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

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    FAMAR CDMO- From early development to commercial manufacturing.

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    evonik-m-2025-09-08

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    Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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    EVENTS

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    About

    We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic a...
    We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.

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    CONTACT DETAILS

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    Olon S.p.AItaly Flag
    Country
    Country
    Italy
    Address
    Address
    Societa con Socio unico, Strada Rivoltana km 6/7, 20090 Rodano (Milano)
    Telephone
    Telephone
    +39 02 95 231
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://olonspa.com/
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    Linkedin
    https://in.linkedin.com/company/olon-spa
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    Twitter

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    CPhI WW Frankfurt

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    "50 Years of Innovation: Mikart

    mic"50 Years of Innovation: Mikart's legacy and what's next in CDMO excellence"

    This week, SpeakPharma interviews Michael Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services. In this exclusive interview, Kallelis discusses how Mikart maintains its competitive edge through its Pharmaceutical Development Services team, quality control framework, and commitment to customized business solutions. Kallelis also explores the company's focus on liquid suspensions manufacturing, driven by growing demand from aging populations and pediatric patients, and explains how Mikart balances traditional family business values with modern innovation. HIGHLIGHTS// celebrating its 50th anniversary/ reputation for technical expertise/ how Mikart maintains its competitive edge Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?  Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers. HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of full aggregate serialization/ attract both new and returning customers How has Mikart maintained its competitive edge in a constantly evolving pharmaceutical landscape? Our customers consistently tell us that what sets us apart is our technical expertise, high service level, and flexible, customized business terms. At the core of our competitiveness is our focus on Pharmaceutical Development Services (PDS). Mikart's PDS opinion leaders are actively engaged in business development and form early, collaborative relationships with our customers' technical teams. From the outset, our prospects and clients work directly with Mikart's experienced formulation chemists, analytical method developers, and process-oriented engineers to design robust, reproducible, and efficient processes. This hands-on development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team. The result is disciplined problem-solving, timely FDA submissions, and a "right-first-time" philosophy that accelerates time-to-market. We operate with a strong sense of urgency and consistently deliver a high level of customer satisfaction. What truly differentiates Mikart is our commitment to customized business terms that eliminate common roadblocks seen with other CDMOs. Our secret sauce is our exceptional service and flexibility in helping our customers bring innovative medicines to patients. HIGHLIGHTS// technical expertise, high service level/ flexible, customized business terms/ comprehensive quality control testing framework/ dedicated Quality Assurance and Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market What capabilities or services does Mikart offer today that didn't exist 10 or 20 years ago? Mikart was an early leader in serialization, implementing full capabilities well ahead of the industry timeline. This proactive approach has kept our packaging team in high demand. We also upgraded our tablet compression equipment to enhance both speed and reliability. To support growing development needs, we invested in new lab-scale development equipment, unit dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite dedicated to closed-system manufacturing of liquids and suspensions. Most recently, we launched a multi-million dollar expansion of our packaging lines to support higher-speed tablet filling, powder-in-bottle formats, and new liquid fill capabilities. HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/ multi-million dollar expansion of our packaging lines Why are liquid suspensions becoming such a key focus, and how is Mikart positioned? Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them. There is growing industry demand for high-quality suspension manufacturing, driven by the needs of the aging baby boomer population and pediatric patients. For both groups, swallowing tablets or capsules can be difficult, making oral liquid suspensions a more practical alternative. In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable. HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions offer pharmacological advantages/ improve dosing compliance How does Mikart balance tradition with innovation to meet modern customer demands?  At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority. Each customer is supported by a dedicated project manager who serves as their primary point of contact, along with direct access to key team members across departments. This structure ensures our customers are never isolated from our subject matter experts and can get timely, accurate answers to their questions. We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs. HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are never isolated from our subject matter experts/ we rely on market data and customer trends to guide our investments/ meet real market needs Looking ahead, what's in store for Mikart in the next 5-10 years? Mikart's strategic plan is now in full motion, and with the momentum we've built, 50 percent growth is within reach. This projection is backed by a strong pipeline of annual FDA filings, a growing customer base, and a robust portfolio of active Pharmaceutical Development Services projects. As we grow, we remain committed to delivering exceptional service and continuously evolving to meet the changing needs of our customers. With renewed political emphasis on domestic manufacturing for the US market, we are ideally positioned to support the rapid, cost-effective development and production of high-quality medicines here at home. As we approach our 50th anniversary in the CDMO industry, we celebrate our legacy and look forward with optimism to the opportunities ahead in the next 5 to 10 years. HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings 

    Impressions: 2775

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    https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence

    PharmaCompass
    17 Jul 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaIngredients for Innovative FormulationsIngredients for Innovative Formulations

    Ingredients for Innovative Formulations
    Ingredients for Innovative Formulations

    reelIngredients for Innovative Formulations

    This PharmaReel highlights Kirsch Pharma’s expertise in providing premium quality raw materials, custom blends, and tailor-made solutions. With 40+ years of expertise and certified quality (GMP, ISO 9001, FSSC 22000, Halal, Kosher), Kirsch supports pharma, biotech, and nutrition industries worldwide.

    Impressions: 968

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Global API micronization market set to surge 49% by 2030, led by specialized industry pioneers

    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.
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    Impressions: 2526

    https://www.pharmacompass.com/radio-compass-blog/global-api-micronization-market-set-to-surge-49-by-2030-led-by-specialized-industry-pioneers

    #Phispers by PHARMACOMPASS
    10 Sep 2025
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    NEWS #PharmaBuzz

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    Olon Group strengthens bioproduction leadership with appointment
    Olon Group strengthens bioproduction leadership with appointment

    28 Apr 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/04/28/3069355/0/en/Olon-Group-Strengthens-Its-Leadership-in-Bioproduction-with-Two-Strategic-Appointments-in-France.html

    GLOBENEWSWIRE
    28 Apr 2025
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    Olon Receives 2025 CMO Excellence in Green Chemistry Award
    Olon Receives 2025 CMO Excellence in Green Chemistry Award

    16 Apr 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/04/16/3062656/0/en/Olon-Receives-2025-CMO-Excellence-in-Green-Chemistry-Award.html

    GLOBENEWSWIRE
    16 Apr 2025
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    Olon Expands Portfolio With High Socio-Health Value Therapies
    Olon Expands Portfolio With High Socio-Health Value Therapies

    25 Nov 2024

    // PRESS RELEASE

    https://olonspa.com/news/olon-expanding-the-product-portfolio-to-include-additional-therapies-in-high-socio-health-value-areas/

    PRESS RELEASE
    25 Nov 2024
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    Olon Releases Its Annual Esg Report
    Olon Releases Its Annual Esg Report

    19 Nov 2024

    // PRESS RELEASE

    https://olonspa.com/uncategorized/olon-releases-its-annual-esg-report/

    PRESS RELEASE
    19 Nov 2024
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    Recombinant And Semisynthesis Of Peptides Paper Published
    Recombinant And Semisynthesis Of Peptides Paper Published

    06 Nov 2024

    // PRESS RELEASE

    https://olonspa.com/news/focus/recombinant-and-semisynthesis-of-peptideds-scientific-paper-by-rd-experts-published-by-the-royal-society-of-chemistry/

    PRESS RELEASE
    06 Nov 2024
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    Olon to Host Ultra-Potent Compound Productions in New Facility
    Olon to Host Ultra-Potent Compound Productions in New Facility

    04 Nov 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/11/04/2973796/0/en/Olon-is-ready-to-host-productions-in-the-new-facility-dedicated-to-ultra-potent-compounds.html

    GLOBENEWSWIRE
    04 Nov 2024
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    ALL APIs

    read-moreClick the button for full data set
    read-moreClick the button for full data set

    01

    Hydroxyurea

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Hydroxyurea

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11899

    Submission : 1996-03-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-263 - Rev 01

    Issue Date : 2024-12-12

    Type : Chemical

    Substance Number : 1616

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10097

    Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy

    Initial Date of Registration : 2010-03-17

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0197

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 73005-0007

    Start Marketing Date : 2023-08-08

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    #PipelineProspector

    Market
    Place

    02

    Quetiapine Hemifumarate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20045

    Submission : 2006-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-022 - Rev 01

    Issue Date : 2023-06-16

    Type : Chemical

    Substance Number : 2541

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10171

    Registrant's Address : Unit No. 3B-38,39&40 on 3rd fl. , Phoenix Paragon plaza, Phoenix Market City, L. B. S. Marg, Kurla(W)-400070,Mumbai,Maharashtra,India

    Initial Date of Registration : 2011-12-22

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0197

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 73005-0003

    Start Marketing Date : 2020-11-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    03

    Rifaximin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Rifaximin

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17974

    Submission : 2004-12-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-125 - Rev 04

    Issue Date : 2025-07-25

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10031

    Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy

    Initial Date of Registration : 2024-02-21

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2022-09-16

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0197

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17337-0043

    Start Marketing Date : 2012-12-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-02-15

    Registration Number : 20230215-209-J-1419

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Della Vittoria, 89 - 26837 Mulazzano (LO), Italy

     VMF Others AUDIT
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    Market
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    04

    Acyclovir

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Acyclovir

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-03

    Pay. Date : 2014-04-22

    DMF Number : 10685

    Submission : 1994-01-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-041 - Rev 05

    Issue Date : 2020-10-20

    Type : Chemical

    Substance Number : 968

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10016

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0077

    Start Marketing Date : 2017-05-17

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Daewoong Pharmaceutical Co., Ltd.

    Registration Date : 2018-02-08

    Registration Number : 20180208-33-A-330-16

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Della Vittoria 89, Cassino d'Alberi, 26837 Mulazzano (LO), Italy

     VMF Others AUDIT
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    #PipelineProspector

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    05

    Acyclovir

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Acyclovir

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20445

    Submission : 2007-04-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2003-218 - Rev 07

    Issue Date : 2025-07-17

    Type : Chemical

    Substance Number : 968

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10178

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2021-12-15

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0041

    Start Marketing Date : 2012-12-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    06

    Bezafibrate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Bezafibrate

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27497

    Submission : 2013-09-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-107 - Rev 04

    Issue Date : 2021-06-15

    Type : Chemical

    Substance Number : 1394

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10019

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0094

    Start Marketing Date : 2020-09-23

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    07

    Bumetanide

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Bumetanide

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-28

    Pay. Date : 2015-09-17

    DMF Number : 10994

    Submission : 1994-07-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-151 - Rev 07

    Issue Date : 2024-08-13

    Type : Chemical

    Substance Number : 1076

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10770

    Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy

    Initial Date of Registration : 2006-09-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0055

    Start Marketing Date : 2013-10-18

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Doxorubicin Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Doxorubicin Hydrochloride

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-04-22

    Pay. Date : 2018-12-17

    DMF Number : 30035

    Submission : 2015-11-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-169 - Rev 04

    Issue Date : 2024-05-06

    Type : Chemical

    Substance Number : 714

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10121

    Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy

    Initial Date of Registration : 2021-08-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0260

    Start Marketing Date : 2015-05-21

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : BANTIVE KOREA CORP.

    Registration Date : 2021-09-03

    Registration Number : 20210420-210-J-515(2)

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Schiapparelli 2, 10036 Settimo Torinese (To), Italy

     VMF Others AUDIT
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    Market
    Place

    09

    Raloxifene Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Raloxifene Hydrochloride

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-10-07

    Pay. Date : 2015-09-22

    DMF Number : 29721

    Submission : 2015-09-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-171 - Rev 00

    Issue Date : 2022-04-08

    Type : Chemical

    Substance Number : 2375

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 303MF10064

    Registrant's Address : Strada Rivoltana Km. 6/7 20053 Rodano (MI), Italy

    Initial Date of Registration : 2021-04-13

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0071

    Start Marketing Date : 2019-08-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Tretinoin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BIOHK2025
    Not Confirmed
    arrow

    Tretinoin

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-10-02

    Pay. Date : 2019-09-25

    DMF Number : 7474

    Submission : 1988-05-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 1998-082 - Rev 08

    Issue Date : 2025-02-24

    Type : Chemical

    Substance Number : 693

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10001

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2017-01-10

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0045

    Start Marketing Date : 2012-12-27

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : DKS Korea Co., Ltd.

    Registration Date : 2022-12-05

    Registration Number : 20221205-209-J-1392

    Manufacturer Name : Olon SPA

    Manufacturer Address : Via Milano 186 I-20024 Garbagnate Milanese Milano, Italy

     VMF Others AUDIT
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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    CEP/COS

    read-more
    read-more

    01

    Acamprosate calcium

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    02

    Aciclovir

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    03

    Aciclovir

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    04

    Acitretin

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    05

    Ambroxol hydrochloride

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    06

    Amiloride hydrochloride dihydrate

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    07

    Amiodarone hydrochloride

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    08

    Amitriptyline hydrochloride

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    09

    Amorolfine hydrochloride

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow

    10

    Aripiprazole

    CEP/COS

    BIOHK2025
    Not Confirmed
    arrow
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    JDMF

    read-more
    read-more

    01

    Aciclovir

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Aciclovir

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Olon S.p.A

    Registration Number : 303MF10178

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2021-12-15

    Latest Date of Registration : 2021-12-15

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    Market
    Place

    02

    Acyclovir

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Acyclovir

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Olon S.p.A

    Registration Number : 218MF10016

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration : 2022-01-11

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    Market
    Place

    03

    Adapalene

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Adapalene

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Olon S.p.A

    Registration Number : 228MF10145

    Registrant's Address : Strada Rivoltana km. 6/7 20053 Rodano (MI), Italy

    Initial Date of Registration : 2016-08-03

    Latest Date of Registration : 2019-12-20

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    Market
    Place

    04

    Bendamustine Hydrochloride

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Bendamustine Hydrochloride

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Olon S.p.A

    Registration Number : 301MF10055

    Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy

    Initial Date of Registration : 2019-08-29

    Latest Date of Registration : 2023-12-06

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    Market
    Place

    05

    Betaxolol Hydrochloride

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Betaxolol Hydrochloride

    Spain
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Derivados Quimicos SAU

    Registration Number : 305MF10078

    Registrant's Address : Camino de Pliego, No. 150, Alcantarilla, 30820, Murcia, Spain

    Initial Date of Registration : 2023-07-12

    Latest Date of Registration : 2023-07-12

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    Market
    Place

    06

    Bezafibrate "KOA"

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Bezafibrate "KOA"

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Olon S.p.A

    Registration Number : 218MF10019

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration : 2021-08-16

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    Market
    Place

    07

    Bicalutamide

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Bicalutamide

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Olon S.p.A

    Registration Number : 219MF10221

    Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy

    Initial Date of Registration : 2007-07-06

    Latest Date of Registration : 2022-10-26

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    Market
    Place

    08

    BUMETANIDE

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    BUMETANIDE

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
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    • WHO-GMP
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    Olon S.p.A

    Registration Number : 218MF10770

    Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy

    Initial Date of Registration : 2006-09-22

    Latest Date of Registration : 2006-09-22

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    Market
    Place

    09

    Cefazolin acid

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Cefazolin acid

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
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    • WHO-GMP
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    Olon S.p.A

    Registration Number : 219MF10322

    Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy

    Initial Date of Registration : 2007-10-24

    Latest Date of Registration : 2020-01-17

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    Market
    Place

    10

    Cefazolin sodium

    JDMF

    BIOHK2025
    Not Confirmed
    arrow

    Cefazolin sodium

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Olon S.p.A

    Registration Number : 219MF10323

    Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy

    Initial Date of Registration : 2007-10-24

    Latest Date of Registration : 2020-09-24

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    EU WC

    read-more
    read-more

    01

    Aprepitant IH/Ph.Eur/USP

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    02

    Aripiprazole IH/Ph.Eur/USP

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    03

    Clobenzorex Hydrochloride IH

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    04

    Clopidogrel Hydrochloride IH

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    05

    Escitalopram Oxalate IH/Ph.E...

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    06

    Hydroxyurea Ph. Eur/USP

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    07

    Lactobionic Acid IH/Ph.Eur

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    08

    Lansoprazole IH/Ph.Eur/USP

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    09

    Minoxidil Ph.Eur/USP

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    10

    Quetiapine Fumarate IH/Ph.Eu...

    Italy
    BIOHK2025
    Not Confirmed
    arrow
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    KDMF

    read-more
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    01

    Acyclovir

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    Acyclovir

    Italy
    arrow
    BIOHK2025
    Not Confirmed
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    Olon S.p.A

    Registrant Name : Daewoong Pharmaceutical Co., Ltd.

    Registration Date : 2018-02-08

    Registration Number : 20180208-33-A-330-16

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Della Vittoria 89, Cassino d'Alberi, 26837 Mulazzano (LO), Italy

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    Market
    Place

    02

    Alitretinoin

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    Alitretinoin

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
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    Olon S.p.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2018-10-23

    Registration Number : 20181023-209-J-265

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Milano 186 20024 Garbagnate Milanese (MI), Italy

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    Market
    Place

    03

    Alitretinoin

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    Alitretinoin

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
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    • WHO-GMP
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    Olon S.p.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-06-13

    Registration Number : 20230613-209-J-1511

    Manufacturer Name : OLON SpA@Micro-Macinazione SA

    Manufacturer Address : Via Milano 186 - 20024 Garbagnate Milanese (MI) - Italy@Zona Artigianale 11, 6995 Mad...

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    Market
    Place

    04

    Betaxolol hydrochloride

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    Betaxolol hydrochloride

    Italy
    arrow
    BIOHK2025
    Not Confirmed
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    • WHO-GMP
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    Olon S.p.A

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2023-05-04

    Registration Number : 20210323-209-J-906(A)

    Manufacturer Name : Olon SPA

    Manufacturer Address : Via Livelli, 1 26852 Casaletto Lodigiano fraz. Mairano (LO) Italy

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    Market
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    05

    Betaxolol hydrochloride

    Italy
    BIOHK2025
    Not Confirmed
    arrow

    Betaxolol hydrochloride

    Italy
    arrow
    BIOHK2025
    Not Confirmed
    • fda
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    Olon S.p.A

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2021-03-23

    Registration Number : 20210323-209-J-906

    Manufacturer Name : Olon SPA

    Manufacturer Address : Via Livelli, 1 26852 Casaletto Lodigiano fraz. Mairano (LO) Italy

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    Olon S.p.A

    Registrant Name : Menarini Korea Co., Ltd.

    Registration Date : 2018-02-21

    Registration Number : 11-1-ND

    Manufacturer Name : OLON SPA

    Manufacturer Address : Via Livelli, 1(loc. FRAZIONE MAIRANO) - 26852 Casaletto Lodigiano, Italy

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    Olon S.p.A

    Registrant Name : Sangjin Corporation

    Registration Date : 2018-07-30

    Registration Number : No. 583-26-ND

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Schiapparelli 2 10036 Settimo Torinese (TO), Italy

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    Olon S.p.A

    Registrant Name : Ilsung IS Co., Ltd.

    Registration Date : 2019-12-30

    Registration Number : No. 583-26-ND(1)

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Schiapparelli 2 10036 Settimo Torinese (TO), Italy

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    Olon S.p.A

    Registrant Name : Handok Co., Ltd.

    Registration Date : 2022-07-13

    Registration Number : 20220713-210-J-1333

    Manufacturer Name : Olon SpA

    Manufacturer Address : Via Schiapparelli 2, 10036 Settimo Torinese (TO), Italy

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    Olon S.p.A

    Registrant Name : Heilion Korea Co., Ltd.

    Registration Date : 2019-09-18

    Registration Number : 20190918-80-D-155-21

    Manufacturer Name : OLON SpA@[Intermediate Zodiclo...

    Manufacturer Address : Via Benvenuto Cellini, 20, 20054 Segrate, Milano, Italy@[Intermediate Zodiclofenac So...

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    Contact Capua BioServices and get a quotation

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