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    Company profile for Skyepharma

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    Bigger Thinking for nanomedicines 28 March 2023

    28 Mar 2024

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    Coating your oral solid drugs protect & optimize!

    03 Mar 2024

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    Skyepharma: the specialized CDMO growing in double digits

    24 Jan 2024

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    Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

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    About

    Skyepharma Production SAS is an expert & innovative CDMO in complex OSDs possessing its proprietary technologies of modified release & multilayer tablets. It offers a broad range of services, from early-stage development to industrial manufacturing & packaging. It also has the capacity for oncologic product development & manufacturing, as well as for NCEs, Highly potent molecules, non-sexual hormones, controlled substances, biotechnologies & others. Skyepharma has a proven record of successful projects, with a skilled scientific team which is agile and high-quality oriented. Skyepharma is GMP certified as well as FDA, ANSM & ANVISA approved.

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    SkyepharmaFrance Flag
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    France
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    55 Rue du Montmurier, 38070 Saint-Quentin-Fallavier
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    +33 474952020
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    info@skyepharma.com
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    https://www.skyepharma.com/
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    INTERVIEW #SpeakPharma

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    “Skyepharma: the specialized CDMO growing in double digits”

    “Skyepharma: the specialized CDMO growing in double digits”

    This week, SpeakPharma interviews David Lescuyer, CEO, and Benoit Mougeot, CFO, of Skyepharma, a fully integrated French CDMO for complex oral solid dosage forms. Over the last six years, Skyepharma has transformed itself from a basic contract manufacturing organization (CMO) to an agile, expert, and differentiated contract development and manufacturing organization (CDMO). Continuous, proactive and major capital investments and a strong people-based unique expertise have generated double-digit growth for Skyepharma over the past five years. Skyepharma is now actively working on building stronger partnerships to constantly improve the supply chain of the health industry and the lives of many patients.Over the last six years, Skyepharma has truly transformed itself from a CMO to an agile CDMO. Can you briefly take us through this journey?Lescuyer: Yes, the last few years have been quite eventful. We initiated this journey in 2016, to establish a first-in-class expert CDMO. In 2021, further to the successful completion of a MBO (short for management buyout), Skyepharma became a 100 percent French-owned independent CDMO, owned by its management team, which has more than 150 years of cumulative experience in the pharmaceutical business and a proven expertise in the CDMO business. Over the last two years, we have emerged as a key player in the development of oral solid drugs and the delivery of oral complex technologies. We are experiencing double-digit growth.Such a transformation could not have been easy. Can you tell us what were some of the things Skyepharma relied on to bring about this change?Mougeot: Our transformation and growth have leaned on two strong pillars.The first is the development of our people. The company has invested a lot in skilling up our people and establishing a strong and specific organizational culture. As a result, we are offering a recognized customer experience to our partners, where agility, reduced time-to-market and breakthrough innovation are key differentiators.The second pillar is our capital investment strategy. We deployed an investment to the tune of €40 million (US$ 42 million) between 2016 and 2023. This investment is being used not only to revamp our manufacturing and development suites but also to upgrade our FDA-approved facility and to tremendously expand our development and production capabilities with, for instance, the design and building of two new, state-of-the-art areas fully-dedicated to highly potent molecules, including oncology. This way, we will keep offering more support to our partners for their high-value projects.You said Skyepharma has been growing in double digits. Did Covid-19 impact your growth?Mougeot: We have been successful in building a resilient model that was able to withstand the Covid years.Given the macroeconomic context, we have been leaning on a strong operational organization and leadership team, resulting in a continuous premium service level that was kept high during the pandemic.This is what we mean by customer experience!Lescuyer: Our approach is to be a “PDMO”, wherein “P” stands for partner, that focuses on long-term partnerships. Anticipating the unmet needs of our partners throughout the supply chain and early in their development programs, there’s now a world of opportunities for innovative and reliable companies in the CDMO marketplace.Our organic growth strategy relies on our expertise for complex and hard-to-make drugs and in our ability to keep investing in science and added-value capabilities, such as high-potency drugs. Innovative initiatives such as our proprietary Skyehub model, the expansion of our proprietary technologies’ portfolio and related IP (intellectual property), and academic partnerships are just some of the ways in which we are differentiating ourselves from other CDMOs.What is the Skyehub model? Can you elaborate on this initiative?Lescuyer: Skyehub is part of our strategic opportunities for adjacencies. France and Europe are dramatically missing large-scale clinical and commercial capacities for bioproduction. We have decided to allocate 10,000 square meters of our real estate close to Lyon to build and run dedicated facilities for biotech companies looking for such capacity. We take care of the construction and certification of the related buildings. The resident companies will benefit from our industrial expertise, from our quality systems, while also allowing them the opportunity to run their production with their own staff.In February 2022, we entered into a partnership with MaaT Pharma to establish the first cGMP manufacturing facility dedicated to microbiome ecosystem therapies in France, the largest such facility in Europe. Through this partnership, we will provide MaaT Pharma with a dedicated 1,700+ square meter biotech plant, with the potential to double if needed. This will support the clinical and commercial development of MaaT’s most advanced assets – MaaT013 and MaaT033. It will also support the expansion of R&D manufacturing capacities for the development of its new drug (MaaT03x).Other partnerships will be signed, focusing on microbiome-based therapies or other innovative biotechnologies.More than just bioproduction capacity, our proprietary Skyehub model is clearly a value accelerator for our partners.Where does Skyepharma go from here? Tell us about your future plans.With our highly skilled team, experienced in transforming sites into centers of excellence, we have been able to build strong partnerships and extensive collaborations with our existing clients, while also taking on new partners. We offer seamless and adapted solutions support for the most demanding projects from our partners by utilizing our capacity, services and expertise, focusing on reducing time to market.Skyepharma is now the preferred supplier for quite a few pharma companies, ranging from virtual pharmaceutical companies (VPCs) to Big Pharma. Having invested twice our yearly revenue over the past five years, Skyepharma will now continue to leverage its differentiators to keep growing and remain the solution provider for pharma companies facing strong supply and technical challenges in complex oral solid dosage (OSD) and biotech spaces. 

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    #SpeakPharma With Skyepharma
    18 Jan 2023
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    CORPORATE CONTENT #SupplierSpotlight

    Corporate Presentation

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      https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-84876.pdf

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    Controlling Lag-time & Release Kinetics of Press-coated Tablets

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    Microfluidization - Skyepharma Collaboration with Lyon University

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    GMP Certificate 2024

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      https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-35695.pdf

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    Leading Pharmaceutical Development in a Sustainable Way

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    Skyepharma & MaaT Pharma launches a facility for Biotherapies

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    Services

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    Quality By Design & Expertise

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    Compaction Simulation Expertise

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    NEWS #PharmaBuzz

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    Bigger Thinking for nanomedicines 28 March 2023
    Bigger Thinking for nanomedicines 28 March 2023

    28 Mar 2024

    // PRESS RELEASE

    https://www.skyepharma.com/bigger-thinking-for-nanomedicines/

    PRESS RELEASE
    28 Mar 2024
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    Coating your oral solid drugs protect & optimize!
    Coating your oral solid drugs protect & optimize!

    03 Mar 2024

    // PRESS RELEASE

    https://www.skyepharma.com/coating-your-tablets-protect-optimize/

    PRESS RELEASE
    03 Mar 2024
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    Skyepharma: the specialized CDMO growing in double digits
    Skyepharma: the specialized CDMO growing in double digits

    24 Jan 2024

    // PRESS RELEASE

    https://www.skyepharma.com/skyepharma-the-specialized-cdmo-growing-in-double-digits/

    PRESS RELEASE
    24 Jan 2024
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    Skyepharma CDMO makes debut at Nordic Life Science Days
    Skyepharma CDMO makes debut at Nordic Life Science Days

    23 Nov 2023

    // PHARMACEUTICAL-TECHNOLOGY

    https://www.pharmaceutical-networking.com/skyepharma-cdmo-makes-debut-at-nordic-life-science-days/

    PHARMACEUTICAL-TECHNOLOGY
    23 Nov 2023
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    Biophytis And Skyepharma Sign A Partnership Agreement For Bio101
    Biophytis And Skyepharma Sign A Partnership Agreement For Bio101

    25 Sep 2023

    // PRESS RELEASE

    https://www.biophytis.com/en/biophytis-and-skyepharma-sign-a-partnership-agreement-for-the-production-of-sarconeos-bio101/

    PRESS RELEASE
    25 Sep 2023
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    MaaT and Skyepharma Complete Construction of Largest Manufacturing Facility
    MaaT and Skyepharma Complete Construction of Largest Manufacturing Facility

    12 Sep 2023

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20230911074606/en

    BUSINESSWIRE
    12 Sep 2023
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    Services

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    Analytical

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    Drug Product Manufacturing

    Discover their expertise for : Drug Product Manufacturing

    Sales, Marketing, Registration

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    Packaging

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    API & Drug Product Development

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    KEY SERVICES

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    TOP RANKED SUPPLIER FOR:

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    Formulation Development Services of Modified Release forms
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    Manufacturing Vaccines
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    Potent Compounds Capsules
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    Diffucaps® Customized Release Technology
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    Inspections and registrations

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    FDA

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    01

    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2019-09-06

    Skyepharma

    City : St Quentin Fallavier

    State :

    Country/Area : FR

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2019-09-06

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2015-06-19

    Skyepharma

    City : St Quentin Fallavier

    State :

    Country/Area : FR

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-06-19

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

    Skyepharma

    City : St Quentin Fallavier

    State :

    Country/Area : FR

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

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    FDA Audited

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-02

    Skyepharma

    City : St Quentin Fallavier

    State :

    Country/Area : FR

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-02

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    FDA Audited

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    District Decision : No Action Indicated

    Inspection End Date : 2009-09-18

    Skyepharma

    City : Muttenz

    State :

    Country/Area : CH

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-09-18

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    EDQM

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    GMP Certified

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    Type : GMP Certificates

    Number : 2024_HPF_FR...

    EudraGMDP Key : 169998

    Country : France

    Issue Date : 2024-05-29

    Post Code :

    NCA Ref : 409600616A86...

    City : St Quentin Fallavier

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    Type : GMP Certificates

    Number : 2024_HPF_FR...

    EudraGMDP Key : 169997

    Country : France

    Issue Date : 2024-05-29

    Post Code :

    NCA Ref : 409600616A86...

    City : St Quentin Fallavier

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    Type : GMP Certificates

    Number : GMPEHV-CH-1...

    EudraGMDP Key : 110225

    Country : Switzerland

    Issue Date : 2020-11-23

    Post Code :

    NCA Ref : 1001445

    City : Muttenz

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    GMP Certified

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    Type : GMP Certificates

    Number : GMPEI-CH-10...

    EudraGMDP Key : 110226

    Country : Switzerland

    Issue Date : 2020-11-23

    Post Code :

    NCA Ref : 1001445

    City : Muttenz

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    05

    GMP Certified

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    Type : GMP Certificates

    Number : 2007/UMC/PT...

    EudraGMDP Key : 1741

    Country : U.S.A

    Issue Date : 2007-11-30

    Post Code :

    NCA Ref : 628412306415...

    City : San Diego

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    GDUFA

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    GDUFA fees paid

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    Virtual BoothSkyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.

    Paid in : 2018

    Skyepharma

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : SkyePharma Productions SAS

    Business Address : Zone Industrielle Chesnes Ou...

    FEI Number : 3002808180

    Country : France

    Paid in : 2018

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