Company profile for Skyepharma

Skyepharma-PSE
News

DATA COMPILATION
#PharmaFlow

PharmaCompass

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

Related CompaniesRelated Companies

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.

CONTACT DETAILS

Click the arrow to open the dropdown
Country
Country
France
Address
Address
55 Rue du Montmurier, 38070 Saint-Quentin-Fallavier
Telephone
Telephone
+33 474952020
Twitter
Twitter
Contact Info
Others

Events

Webinars & Exhibitions

Default Event

DCAT Week

Not Confirmed

envelop Contact Supplier

DCAT Week

Post an Enquiry

Meeting

Digital content read-more

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

read-more
read-more
“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: 2319

https://www.pharmacompass.com/speak-pharma/a-differentiated-expert-and-agile-cdmo-player-in-the-osd-market

#SpeakPharma With Skyepharma
18 Jan 2023

CORPORATE CONTENT #SupplierSpotlight

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

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-20701.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1652421761.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1707.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1647412480.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1646369243.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1647862827.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1551421586.pdf

    https://www.pharmacompass.com/pdf/party/content/skyepharma-party-content-1551421802.pdf

NEWS #PharmaBuzz

read-more
read-more

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

PRESS RELEASE
28 Mar 2024

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

PRESS RELEASE
03 Mar 2024

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

PRESS RELEASE
24 Jan 2024
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

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

PRESS RELEASE
25 Sep 2023

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

BUSINESSWIRE
12 Sep 2023

Drugs in Development

read-more
read-more

Details:

Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.


Lead Product(s): Fluticasone Propionate,Formoterol Fumarate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Flutiform

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Mundipharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration April 16, 2024

Skyepharma Company Banner

01

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.

Brand Name : Flutiform

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 16, 2024

Skyepharma Company Banner

Details:

Under the partnership, Skyepharma will develop finished product batches meeting the GMP standards of Sarconeos (20-hydroxyecdysone), an orally administered small molecule, for severe forms of Covid-19.


Lead Product(s): 20-Hydroxyecdysone

Therapeutic Area: Infections and Infectious Diseases Brand Name: Sarconeos

Study Phase: Phase II/ Phase IIIProduct Type: Small molecule

Sponsor: Biophytis

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership September 25, 2023

Skyepharma Company Banner

02

Skyepharma

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : 20-Hydroxyecdysone

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase II/ Phase III

Partner/Sponsor/Collaborator : Biophytis

Deal Size : Undisclosed

Deal Type : Partnership

Details : Under the partnership, Skyepharma will develop finished product batches meeting the GMP standards of Sarconeos (20-hydroxyecdysone), an orally administered small molecule, for severe forms of Covid-19.

Brand Name : Sarconeos

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 25, 2023

Skyepharma Company Banner

Details:

The facility will aim to produce several thousand enemas of the Company’s lead candidate (MaaT013) for Graft-versus-Host disease and capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation.


Lead Product(s): MaaT013

Therapeutic Area: Immunology Brand Name: MaaT013

Study Phase: Phase IIIProduct Type: Large molecule

Recipient: MaaT Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership February 08, 2022

Skyepharma Company Banner

03

Skyepharma

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : MaaT013

Therapeutic Area : Immunology

Highest Development Status : Phase III

Recipient : MaaT Pharma

Deal Size : Undisclosed

Deal Type : Partnership

Details : The facility will aim to produce several thousand enemas of the Company’s lead candidate (MaaT013) for Graft-versus-Host disease and capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell...

Brand Name : MaaT013

Molecule Type : Large molecule

Upfront Cash : Undisclosed

February 08, 2022

Skyepharma Company Banner

Details:

Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments, as well as manufacturing a laboratory-scale batch of IHL-216A (Cannabidiol) to support toxicological studies.


Lead Product(s): Cannabidiol,Isoflurane

Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: IHL-216A

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Incannex Healthcare

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 22, 2021

Skyepharma Company Banner

04

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments, as well as manufacturing a laboratory-scale batch of IHL-216A (Cannabidiol) to support toxicolog...

Brand Name : IHL-216A

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 22, 2021

Skyepharma Company Banner

Details:

IPA-001 is inhaled formulation displayed viricidal activity against SARS-CoV2 after 5 minutes contact time. It is purified extracts from a plant source. These extracts contain proteolytic enzymes that have been shown to rapidly inactivate the SARS-CoV-2 virus in vitro.


Lead Product(s): IPA-001

Therapeutic Area: Infections and Infectious Diseases Brand Name: IPA-001

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Inspira

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 06, 2021

Skyepharma Company Banner

05

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : IPA-001 is inhaled formulation displayed viricidal activity against SARS-CoV2 after 5 minutes contact time. It is purified extracts from a plant source. These extracts contain proteolytic enzymes that have been shown to rapidly inactivate the SARS-CoV-2 ...

Brand Name : IPA-001

Molecule Type : Small molecule

Upfront Cash : Undisclosed

May 06, 2021

Skyepharma Company Banner

Details:

Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.


Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Fluticasone Propionate/Salmeterol-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Hikma Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2021

Skyepharma Company Banner

06

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.

Brand Name : Fluticasone Propionate/Salmeterol-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 21, 2021

Skyepharma Company Banner

Details:

The new device is an evolution of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus® programme, enabling accelerated development under this agreement.


Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Fluticasone Propionate/Salmeterol-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Hikma Pharmaceuticals

Deal Size: $95.0 million Upfront Cash: $15.0 million

Deal Type: Agreement December 17, 2020

Skyepharma Company Banner

07

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : The new device is an evolution of Vectura’s lever-operated multi-dose (LOMI) device and builds on Vectura and Hikma’s shared experience with the generic Advair Diskus® programme, enabling accelerated development under this agreement.

Brand Name : Fluticasone Propionate/Salmeterol-Generic

Molecule Type : Small molecule

Upfront Cash : $15.0 million

December 17, 2020

Skyepharma Company Banner

Details:

This agreement provides an opportunity for Vectura to realise value from its historical research and investment in VR588, whilst expanding its CDMO development services portfolio by supporting the product's further development with Kinaset.


Lead Product(s): VR588

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: VR588

Study Phase: Phase IProduct Type: Small molecule

Recipient: Kinaset Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement November 30, 2020

Skyepharma Company Banner

08

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : This agreement provides an opportunity for Vectura to realise value from its historical research and investment in VR588, whilst expanding its CDMO development services portfolio by supporting the product's further development with Kinaset.

Brand Name : VR588

Molecule Type : Small molecule

Upfront Cash : Undisclosed

November 30, 2020

Skyepharma Company Banner

Details:

Fluticasone Propionate / Salmeterol or VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.


Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: VR315

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Hikma Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 22, 2020

Skyepharma Company Banner

09

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Fluticasone Propionate / Salmeterol or VR315 is a generic, inhaled combination therapy for asthma/COPD delivered using Vectura's proprietary dry powder inhaler and formulation technology.

Brand Name : VR315

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 22, 2020

Skyepharma Company Banner

Details:

Vectura will support the development of a single use device/formulation combination for evaluation in Phase I of inhaled oxytocin, and then expedite technical transfer to a commercial manufacturer to advance to Phase III and commercial launch.


Lead Product(s): Oxytocin

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

Study Phase: PreclinicalProduct Type: Peptide

Sponsor: Monash University

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement September 14, 2020

Skyepharma Company Banner

10

Vectura Ltd

United Kingdom
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Vectura will support the development of a single use device/formulation combination for evaluation in Phase I of inhaled oxytocin, and then expedite technical transfer to a commercial manufacturer to advance to Phase III and commercial launch.

Brand Name : Undisclosed

Molecule Type : Peptide

Upfront Cash : Undisclosed

September 14, 2020

Skyepharma Company Banner
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

Brand Name : TRIGLIDE

Skyepharma

Dosage Form : TABLET; ORAL

Proprietary Name : TRIGLIDE

Dosage Strength : 50MG

Approval Date : 2005-05-07

Application Number : 21350

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Skyepharma Company Banner

02

Brand Name : TRIGLIDE

Skyepharma

Dosage Form : TABLET; ORAL

Proprietary Name : TRIGLIDE

Dosage Strength : 160MG

Approval Date : 2005-05-07

Application Number : 21350

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Skyepharma Company Banner

03

Brand Name : ISOSORBIDE MONONITRA...

Skyepharma

Dosage Form : TABLET, EXTENDED RELEASE; ORAL

Proprietary Name : ISOSORBIDE MONONITRATE

Dosage Strength : 60MG

Approval Date : 1999-10-07

Application Number : 75166

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Skyepharma Company Banner

Services

Discover the service capabilities from this company

Analytical

Discover their expertise for : Analytical

Drug Product Manufacturing

Discover their expertise for : Drug Product Manufacturing

Sales, Marketing, Registration

Discover their expertise for : Sales, Marketing, Registration

Packaging

Discover their expertise for : Packaging

Contract Services

read-more
read-more
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API & Drug Product Development

Discover their expertise for : API & Drug Product Development

KEY SERVICES

read-more
read-more

TOP RANKED SUPPLIER FOR:

Formulation Development Services of Modified Release forms
full-view
Manufacturing Vaccines
full-view
Potent Compounds Capsules
full-view
Tablet coating
full-view
Diffucaps® Customized Release Technology
full-view

Inspections and registrations

Check the inspections & registration from this company

FDA

read-more
read-more

01

FDA Audited

USA

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

Skyepharma Company Banner

02

FDA Audited

USA

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

Skyepharma Company Banner

03

FDA Audited

USA

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

Skyepharma Company Banner

04

FDA Audited

USA

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

Skyepharma Company Banner

05

FDA Audited

USA

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

Skyepharma Company Banner
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty