Skyepharma DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Collaboration Eneapharm & Skyepharma

20 Jun 2025

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Skyepharma Expands Oncology Operational Facility in France

16 May 2025

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Bigger Thinking for nanomedicines 28 March 2023

28 Mar 2024

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DATA COMPILATION
#PharmaFlow

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CPhI WW Frankfurt

Booth #6.1D44

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DIGITAL CONTENT

2 Interview #SpeakPharma, 25 Corporate Content #SupplierSpotlight, 1 Data Compilation #PharmaFlow, 58 News #PharmaBuzz

media
2 Interview #SpeakPharma
25 Corporate Content #SupplierSpotlight
1 Data Compilation #PharmaFlow
58 News #PharmaBuzz

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 3 FDA Orange Book

3 FDF Dossiers
3 FDA Orange Book

SERVICES

Analytical, Drug Product Manufacturing, Sales, Marketing, Registration, Packaging, API & Drug Product Development

pharmaServices
Analytical
- 1 Analytical Method Development
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Packaging
- 4 Contract Services
API & Drug Product Development
- 5 Formulation Development

KEY SERVICES

Modified Release Capsules, GEOMATRIX: Multi-layer Tablet Technology, SOCTEC - ER Gastro-retentive Technology, Immediate & Modified Release Tablets, Controlled Drug Delivery, GEOCLOCK - Tab-in-Tab Technology, Highly Potent Tablet Manufacturing, Complex OSD Manufacturing, ODT Manufacturing, Chewable Tablet Manufacturing, Bioproduction, Highly Potent Capsule Manufacturing

Modified Release Capsules
GEOMATRIX: Multi-layer Tablet Technology
SOCTEC - ER Gastro-retentive Technology
Immediate & Modified Release Tablets
Controlled Drug Delivery
GEOCLOCK - Tab-in-Tab Technology
Highly Potent Tablet Manufacturing
Complex OSD Manufacturing
ODT Manufacturing
Chewable Tablet Manufacturing
Bioproduction
Highly Potent Capsule Manufacturing

INSPECTIONS & REGISTRATIONS

5 FDA, 5 EDQM, 1 GDUFA

inspections
5 FDA
5 EDQM
1 GDUFA

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

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.

CPhI South East AsiaCPhI South East Asia

Industry Trade Show

Not Confirmed

16-18 July, 2025

MITEC, Kuala Lumpur, Malaysia
CPhI WW FrankfurtCPhI WW Frankfurt

Industry Trade Show

Booth #6.1D44

28-30 October, 2025

Frankfurt
Florida InnovationFlorida Innovation

Industry Trade Show

Attending

05-07 November, 2025

Orlando

CONTACT DETAILS

Click the arrow to open the dropdown

Country

France

Address

55 Rue du Montmurier, 38070 Saint-Quentin-Fallavier

Telephone

+33 474952020

info@skyepharma.com

Website

https://www.skyepharma.com/

https://www.linkedin.com/company/skyepharma/

YouTube

https://www.youtube.com/channel/UCSj2WQGvNTrJr6vBqGo_rhA

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

“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.

Impressions: 2578

CORPORATE CONTENT #SupplierSpotlight

Corporate Presentation

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Skyepharma Strengthens Oncology with New France Facility

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

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Microfluidization - Skyepharma Collaboration with Lyon University

GMP Certificate 2024

Leading Pharmaceutical Development in a Sustainable Way

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Skyepharma & MaaT Pharma launches a facility for Biotherapies

Services

Quality By Design & Expertise

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Compaction Simulation Expertise

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HPAPI Area for Immuno-oncological Treatments

CDMO Expert in Complex Oral Solid Dosage Forms

Interview CPhI WW 2022

Services Presentation

Corporate Video - Center of Excellence

Agile CDMO Partner

Fully Integrated CDMO

Manufacturing Capabilities

Microfluidizer Technology

Pharmaceutical Development Services

Reliable CDMO Partner

Soctec® Technology

Pharmapack 2020- Interview with David Lescuyer

Packaging Services 2020

CPhI Worldwide 2018

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Veranova, Carbogen lead ADC investments; Axplora, Polfa Tarchomin, Famar expand European footprint

During the second quarter (Q2) of 2025, contract development and manufacturing organizations (CDMOs) made substantial investments in specialized therapeutic manufacturing. The quarter also saw CDMOs pursue high-value, complex manufacturing niches, particularly in antibody-drug conjugates (ADCs), cell and gene therapies (CGTs) and oligonucleotides.Alongside these trends, Q2 also saw CDMOs strengthen their footprint in the United States amid concerns over rising tariffs and unpredictable trade policies being enforced by the Trump administration.Regeneron Pharmaceuticals committed over US$ 3 billion through a 10-year agreement with Fujifilm Diosynth Biotechnologies to nearly double its US manufacturing capacity for biologics. Under this agreement, Fujifilm will manufacture and supply drug products for Regeneron at its large-scale facility in Holly Springs, North Carolina.Thermo Fisher Scientific announced plans to invest an additional US$ 2 billion in the US over four years, reinforcing its manufacturing and R&D capabilities. With 64 facilities spread across 37 states, Thermo Fisher aims to bolster American innovation and competitiveness. Similarly, Piramal Pharma announced a US$ 90 million investment plan for expanding two facilities in the US, thereby bringing its total investment in the country to US$ 570 million. View CDMO Activity Tracker for Q2 2025 (Free Excel Available)Veranova, Carbogen lead ADC wave; Axplora doubles down on HPAPI production in ItalyThe quarter saw substantial investments in ADC manufacturing. Veranova announced a US$ 20 million investment in bioconjugation development and cGMP manufacturing capacity at its Devens, Massachusetts campus. With this investment, Veranova will be able to provide a more comprehensive suite of services to its partners developing ADCs and other bioconjugates. Veranova’s total investment in the Devens facility now stands at over US$ 50 million. Swiss CDMO Carbogen announced a US$ 31 million co-investment with an unnamed Japanese investor to expand its capabilities across its Aarau and Neuland (Switzerland) facilities. The facility will address increasing demand for complex and high-value compounds such as ADC drug linkers.Axplora announced a further €35 million (US$ 41 million) expansion of its Farmabios site in Italy, doubling the facility to approximately 108,000 square meters by mid-2026. This investment raises its total spend on the site to over €80 million (US$ 94.05 million) since 2019, supporting the production of highly potent active pharmaceutical ingredients (HPAPIs). Farmabios now stands as a key hub in Axplora’s global CDMO network.Polish pharmaceutical manufacturer Polfa Tarchomin is positioning itself as a significant player in the European CDMO market through its investment in the Center for Development and Production of Highly Potent Drugs. This 12,000 square meter facility has two state-of-the-art production lines designed for filling vials and pre-filled syringes with an annual capacity of 26 million product units.Skyepharma’s projected annual revenues from oncology-linked activities touched €10 million (US$ 11.2 million). The CDMO’s facility in Saint-Quentin-Fallavier is equipped to handle cytotoxic and cytostatic compounds, and is one of the few facilities in France capable of managing HPAPIs for oral anticancer treatments. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Athena acquires Medipha Santé, Famar buys MiP Pharma’s German site to strengthen European footprintDuring the quarter, several CDMOs enhanced their strategic capabilities through M&As. Athena Pharmaceutiques acquired Medipha Santé to build a fully integrated pharmaceutical services platform in Europe. Based in Paris, Athena has strengthened its commercial and regulatory toolbox by bringing aboard Medipha Santé’s 35-strong team, which supports over 100 partner organizations and files approximately 350 dossiers annually with ANSM and other European agencies. With this integration, Athena positions itself as a one-stop CDMO partner.With the acquisition of MiP Pharma’s sterile manufacturing site in Homburg, Germany, the Famar Group has expanded its capabilities in aseptic and lyophilized fill-and-finish operations. The acquisition has strengthened Famar’s position in sterile drug manufacturing. The CDMO now has seven manufacturing facilities in Europe.PCI Pharma Services’ acquisition of Ajinomoto Althea has established a world-class, large-scale manufacturing hub in the San Diego region with state-of-the-art aseptic facilities for prefilled syringes, cartridges and high-potent formulations such as ADCs. PCI Pharma is now amongst the few US-based CDMOs capable of comprehensive ADC manufacturing.Samsung Biologics’ strategic spinoff of its biosimilar business stood out as a significant corporate restructuring exercise during the quarter. The separation of Samsung Bioepis, tentatively renamed Samsung Epis Holdings, aims to enhance Samsung Biologics’ strategic focus and build client trust, as it eliminates potential conflicts between CDMO services and proprietary drug development. The move came after Samsung Biologics inked a contract worth 737.3 billion Korean won (US$ 518 million) with an undisclosed US pharmaceutical company.WuXi Biologics announced a US$ 167 million divestment of its German facility to Terumo and broke ground on a microbial production plant in China. National Resilience, which was launched five years ago as the US drug manufacturer dedicated to broadening access to medicines and protecting biopharma supply chains, said it is shuttering six of its 10 facilities. The company said the sites were “not being fully utilized.” View CDMO Activity Tracker for Q2 2025 (Free Excel Available) MilliporeSigma, Simtra form 5-year ADC alliance; Silexion partners Catalent for siRNA developmentMerck KGaA’s MilliporeSigma and Simtra struck a five-year strategic alliance, combining expertise across the ADC value chain to reduce development timelines and complexity for biopharmaceutical companies. Viralgen collaborated with Trogenix to rapidly scale product supply for TGX-007, an AAV gene therapy for glioblastoma (a type of cancer of the brain and spinal cord). Silexion announced a collaboration with Catalent for small interfacing RNA (siRNA) development and manufacturing. Catalent’s Limoges (France) facility will conduct formulation development and clinical manufacturing for Silexion’s SIL204 candidate, supporting both systemic and intra-tumoral delivery formulations.Skyepharma’s collaboration with Eneapharm through the Skyehub platform aims to support the treatment of patients suffering from exocrine pancreatic insufficiency, including those affected by cystic fibrosis or pancreatic cancer. Orion Corporation reached an agreement with Shilpa Biocare for the distribution of recombinant human albumin in Europe.Meanwhile, Aenova announced the launch of its Aenovation program, an initiative designed to fast-track early development of pharmaceutical formulations. The program addresses the critical challenges of bioavailability and time-to-market faced by poorly soluble drug candidates. View CDMO Activity Tracker for Q2 2025 (Free Excel Available) Our view The quarter saw CDMO developments mimic the broader trends in the pharmaceutical industry, such as onshoring of critical manufacturing capabilities in the US, consolidation of specialized expertise through strategic partnerships, and the relentless focus on emerging therapeutic modalities that promise to transform patient care. With CDMOs continuing to invest in next-generation manufacturing capabilities, we expect the sector to play a crucial role in drug innovation.