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

Bigger Thinking for nanomedicines 28 March 2023

28 Mar 2024

// PRESS RELEASE

Skyepharma: the specialized CDMO growing in double digits

24 Jan 2024

// PRESS RELEASE

Skyepharma CDMO makes debut at Nordic Life Science Days

23 Nov 2023

// PHARMACEUTICAL-TECHNOLOGY

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

CPhI Worldwide, Milan

Booth #18D8

Book a meeting

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DIGITAL CONTENT

2 INTERVIEW #SpeakPharma, 23 CORPORATE CONTENT #SupplierSpotlight, 55 NEWS #PharmaBuzz

media
2 INTERVIEW #SpeakPharma
23 CORPORATE CONTENT #SupplierSpotlight
55 NEWS #PharmaBuzz

DEVELOPMENTS

12 Drugs in Development

12 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 Capsule Manufacturing, GEOMATRIX - Multi-layer Tablet Technology, GEOCLOCK - Press-coated Tablet (Tab-in-Tab), SOCTEC - ER Gastro-retentive Technology, Immediate & Modified Release Tablets, Controlled Drug Delivery, Highly Potent Tablet Manufacturing, Complex OSD Manufacturing, Orally Disintegrating Tablet Manufacturing, Chewable Tablet Manufacturing, Bioproduction, Highly Potent Capsule Manufacturing

Modified Release Capsule Manufacturing
GEOMATRIX - Multi-layer Tablet Technology
GEOCLOCK - Press-coated Tablet (Tab-in-Tab)
SOCTEC - ER Gastro-retentive Technology
Immediate & Modified Release Tablets
Controlled Drug Delivery
Highly Potent Tablet Manufacturing
Complex OSD Manufacturing
Orally Disintegrating Tablet 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 Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Booth #18D8

08-10 October, 2024

Fiera Milano, Italy
Bio-Europe 2024Bio-Europe 2024

Industry Trade Show

Attending

04-06 November, 2024

Stockholm, Sweden
euroPLX 86 MunicheuroPLX 86 Munich

Industry Trade Show

Attending

18-19 November, 2024

Munich, Germany

CONTACT DETAILS

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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.

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