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    Company profile for Olon S.p.A

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    xyz-pharma-m-2025-03-24

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    xyz-pharma-m-2025-03-17

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    EVENTS

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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
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    Italy
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    Societa con Socio unico, Strada Rivoltana km 6/7, 20090 Rodano (Milano)
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    +39 02 95 231
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    enquiries@pharmacompass.com
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    https://olonspa.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

    Impressions: 783

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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

    Radio Compass
    12 Mar 2025
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    Artificial intelligence (AI) is emerging as a transformative force in drug discovery and development. The global AI in drug discovery market was valued at US$ 1.99 billion in 2024 and is estimated to reach US$ 2.65 billion in 2025. Going forward, the market is expected to grow at an impressive compounded annual growth rate (CAGR) of 29.6 percent, to reach a market size of US$ 35.42 billion by 2034, says a report by Polaris Market Research. This growth expectation mirrors the eagerness within the biopharma industry to leverage AI in order to overcome the traditional barriers of lengthy timelines, exorbitant costs, and high failure rates. This eagerness is also being manifested in deal making — Big Pharma has been busy forging alliances with AI-driven drug discovery companies. Over the last two years, almost every big drugmaker, including Novo Nordisk, Merck, BMS, Pfizer, AstraZeneca, Otsuka Pharmaceutical, Novartis and Sanofi, has signed deals with various AI drug discovery companies. PharmaCompass' compilation shows there are scores of molecules discovered by AI currently in discovery and developmental phases, demonstrating the technology's growing impact on pharmaceutical pipelines.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available) Novo, Lilly, BMS invest in AI partnerships; Recursion, Exscientia merge to create AI powerhouse With the transformative potential of AI becoming increasingly evident, we witnessed a slew of deals in the biopharma industry over the last six months. A significant deal in the AI drug discovery space was the merger of two leaders — Recursion and Exscientia — that took place in November last year. Exscientia is now a wholly-owned subsidiary of Recursion. The merger has created a global technology-enabled drug discovery leader with end-to-end capabilities. The merged entity has over 10 clinical and preclinical programs, and around 10 advanced discovery programs in the pipeline.  Apart from this merger, several large drugmakers have struck deals with AI drug discovery firms since September last year. For instance, in January this year, Valo Health and Novo Nordisk expanded their collaboration to discover and develop novel treatments for cardiometabolic diseases. This deal, valued at up to US$ 4.8 billion, aims to harness the power of AI and extensive human datasets. Building on their initial 2023 partnership, it will enable the development of up to 20 drug programs.  Similarly, Pfizer, which is already big on AI, extended its AI drug discovery pact with PostEra and also partnered IgnitionAI to enhance drug discovery — all within the last six months. And Novartis struck a drug discovery deal with Generate BioMedicines in September. Insilico Medicine has been actively forging partnerships. In January, Insilico entered a second exclusive global license agreement with Menarini Group for an AI-discovered preclinical asset targeting high unmet needs in oncology. Insilico also has a tie-up with Sanofi, dating back to 2022. In December 2024, AI Proteins announced a research collaboration and option agreement with BMS to design and optimize mini-proteins for therapeutic use. And in September, Eli Lilly joined hands with Genetic Leap to accelerate the development of genetic medicines. Lilly will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against selected targets.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  AI leads to faster target identification; Insilico, BenevolentAI’s candidates in trials Computational biology, and especially AI, has fundamentally changed the drug discovery paradigm. The traditional method of drug discovery used to take 13 to 15 years, costing an average of US$ 2.5 billion in investment before a drug got approved and launched in the market. Additionally, less than 10 percent of candidates in phase 1 clinical trials used to end up getting approved by the US Food and Drug Administration (FDA). All that has begun to change. According to Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, since 2016, FDA has received approximately 300 submissions that reference AI use as of May 2024. These submissions range from drug development, drug discovery, clinical research, clinical trials as well as post-market safety surveillance and manufacturing. Though we are yet to witness an AI-generated candidate translate into an approved therapy, target identification in drug discovery is visibly becoming a lot faster. This is the process that identifies specific molecules or pathways in the human body that are linked to a disease. The best example of dramatic acceleration of timelines is Insilico Medicine’s development of INS018_055, a candidate for idiopathic pulmonary fibrosis that entered phase 2 trials in June 2023. Using their AI platform PandaOmics, researchers at Insilico compressed target identification from years to just 18 months. Similarly, BenevolentAI successfully employed their AI platform to identify a new target for ulcerative colitis, leading to the development of BEN-8744, a candidate that has been in phase 1a clinical trials since August 2023.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Oncology leads AI drug discovery market; Recursion shows how to repurpose drugs using AI The integration of AI in oncology research has been impactful, accounting for the largest revenue share (about 22.4 percent) in the AI drug discovery market in 2023. AI technologies have accelerated the discovery and development of new cancer treatments, bolstered personalized medicine approaches, and improved clinical trial designs in the arena of this complex disease.  Another promising application is drug repurposing, where AI can identify new therapeutic applications for existing drugs. Recursion Pharmaceuticals’ REC-2282 exemplifies this approach. This therapy is currently in phase 2/3 studies for neurofibromatosis type 2 (a genetic condition that causes tumors to grow along nerves). By repurposing compounds already vetted for safety, this strategy can bypass early-stage failures, reducing both time and cost compared to developing entirely new molecules. However, the use of AI in drug discovery is not without challenges. Exscientia’s EXS-21546, designed to treat solid tumors, entered phase 1/2 trials in 2020 but was discontinued in 2023 after modeling suggested that achieving a suitable therapeutic index would be difficult. Though this is a clinical failure, it highlights AI’s value in identifying potential failures earlier on in the development process, saving resources that would have otherwise been spent on later-stage trials.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Our view The Covid-19 pandemic was a time when humanity felt the urgent need to speed up the process of drug discovery, testing and approvals. It also hastened the process of integrating AI into pharmaceutical research, leading to the launch of Covid vaccines in record time. Today, there is no looking back — AI is bringing about a paradigm shift in how drugs are discovered. With increasing reliance on AI, there is hope that drug discovery will be more accurate, efficient and less time and cost consuming.
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    Impressions: 1292

    https://www.pharmacompass.com/radio-compass-blog/ai-drug-discovery-market-to-grow-30-cagr-to-reach-us-35-bn-by-2034-novo-lilly-bms-forge-deals

    #PharmaFlow by PHARMACOMPASS
    13 Mar 2025
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    NEWS #PharmaBuzz

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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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    Opening Ceremony Of R&D Synthetic Laboratory -3
    Opening Ceremony Of R&D Synthetic Laboratory -3

    24 Oct 2024

    // PRESS RELEASE

    https://olonspa.com/news/opening-ceremony-of-rd-synthetic-laboratory-3/

    PRESS RELEASE
    24 Oct 2024
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    Enrico Zanetti Appointed As Business Development Director
    Enrico Zanetti Appointed As Business Development Director

    15 Oct 2024

    // PRESS RELEASE

    https://olonspa.com/news/enrico-zanetti-as-the-new-business-development-and-marketing-director/

    PRESS RELEASE
    15 Oct 2024
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    ALL APIs

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

    01

    Quetiapine Hemifumarate

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

    ASPEN
    Not Confirmed
    arrow

    Quetiapine Hemifumarate

    Italy

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

    arrow
    ASPEN
    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 : 20045

    Submission : 2006-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-275 - Rev 00

    Issue Date : 2025-01-10

    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 : 2019-09-09

    Valid Till : 2022-09-08

    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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    Web Link

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    #PipelineProspector

    Market
    Place

    02

    Rifaximin

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

    ASPEN
    Not Confirmed
    arrow

    Rifaximin

    Italy

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

    arrow
    ASPEN
    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 : R0-CEP 2019-125 - Rev 03

    Issue Date : 2021-07-05

    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 : 2020-01-29

    Valid Till : 2022-10-08

    Written Confirmation Number : WC-0197A3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17337-0032

    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
    Place

    03

    Aciclovir

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

    ASPEN
    Not Confirmed
    arrow

    Aciclovir

    Italy

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

    arrow
    ASPEN
    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 : 17337-0005

    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 : 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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    Market
    Place

    04

    Aciclovir

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

    ASPEN
    Not Confirmed
    arrow

    Aciclovir

    Italy

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

    arrow
    ASPEN
    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 : R1-CEP 2003-218 - Rev 06

    Issue Date : 2021-04-26

    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 : 17337-0005

    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 : 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

    Market
    Place

    05

    Adapalene

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

    ASPEN
    Not Confirmed
    arrow

    Adapalene

    Italy

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

    arrow
    ASPEN
    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 : 2014-11-12

    Pay. Date : 2014-02-14

    DMF Number : 19621

    Submission : 2006-07-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-259 - Rev 00

    Issue Date : 2023-07-28

    Type : Chemical

    Substance Number : 2445

    Status : Valid

     JDMF arrow-down
    ✖

    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 :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0006

    Start Marketing Date : 2016-03-07

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Bezafibrate

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

    ASPEN
    Not Confirmed
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    Bezafibrate

    Italy

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

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    ASPEN
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    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 2001-149 - Rev 07

    Issue Date : 2020-09-18

    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

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    07

    Bumetanide

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

    ASPEN
    Not Confirmed
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    Bumetanide

    Italy

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

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

    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 : 17337-0011

    Start Marketing Date : 2012-12-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    Doxorubicin Hydrochloride

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

    ASPEN
    Not Confirmed
    arrow

    Doxorubicin Hydrochloride

    Italy

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

    arrow
    ASPEN
    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 : Boxter Co., Ltd.

    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

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    09

    Hydroxyurea

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

    ASPEN
    Not Confirmed
    arrow

    Hydroxyurea

    Italy

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

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    ASPEN
    Not Confirmed
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    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 : R1-CEP 2003-015 - Rev 05

    Issue Date : 2023-04-03

    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-WC NDC arrow-down
    ✖

    NDC Package Code : 17337-0022

    Start Marketing Date : 2012-12-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Raloxifene Hydrochloride

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

    ASPEN
    Not Confirmed
    arrow

    Raloxifene Hydrochloride

    Italy

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

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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

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    CEP/COS

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    01

    Acamprosate calcium

    CEP/COS

    ASPEN
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    02

    Aciclovir

    CEP/COS

    ASPEN
    Not Confirmed
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    03

    Aciclovir

    CEP/COS

    ASPEN
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    04

    Acitretin

    CEP/COS

    ASPEN
    Not Confirmed
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    05

    Adapalene

    CEP/COS

    ASPEN
    Not Confirmed
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    06

    Ambroxol hydrochloride

    CEP/COS

    ASPEN
    Not Confirmed
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    07

    Amiloride hydrochloride dihydrate

    CEP/COS

    ASPEN
    Not Confirmed
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    08

    Amiodarone hydrochloride

    CEP/COS

    ASPEN
    Not Confirmed
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    09

    Amitriptyline hydrochloride

    CEP/COS

    ASPEN
    Not Confirmed
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    10

    Amorolfine hydrochloride

    CEP/COS

    ASPEN
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    Contact Olon S.p.A and get a quotation

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