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Latest Content by PharmaCompass
Skyepharma, an Expert and Innovative CDMO Partner for tailor-made solutions in complex oral solids and bioproduction.
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28 Mar 2024
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03 Mar 2024
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24 Jan 2024
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https://www.skyepharma.com/skyepharma-the-specialized-cdmo-growing-in-double-digits/
23 Nov 2023
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https://www.pharmaceutical-networking.com/skyepharma-cdmo-makes-debut-at-nordic-life-science-days/
25 Sep 2023
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https://www.biophytis.com/en/biophytis-and-skyepharma-sign-a-partnership-agreement-for-the-production-of-sarconeos-bio101/
12 Sep 2023
// BUSINESSWIRE
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
Lead Product(s) : Fluticasone Propionate,Formoterol Fumarate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Recipient : Mundipharma
Deal Size : Undisclosed
Deal Type : Collaboration
Mundipharma, Vectura Plan to Reformulate flutiform® to Reduce Carbon Footprint
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
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
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
Biophytis and Skyepharma Sign a Partnership Agreement for The Production of Sarconeos (BIO101)
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
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
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
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
Lead Product(s) : Cannabidiol,Isoflurane
Therapeutic Area : Trauma (Emergency, Injury, Surgery)
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Incannex Healthcare
Deal Size : Undisclosed
Deal Type : Agreement
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
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
Lead Product(s) : IPA-001
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inspira
Deal Size : Undisclosed
Deal Type : Agreement
Vectura, Inspira Pharmaceuticals Team Up to Develop Potential Inhaled COVID-19 Treatment
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
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
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Vectura Highlights Update Made by Hikma on Launch of Generic Advair Diskus®
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
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
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : $95.0 million
Deal Type : Agreement
Vectura Earns $11m Milestone as Hikma Receives US FDA Approval for Generic Advair Diskus®
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
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
Lead Product(s) : VR588
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Recipient : Kinaset Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
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
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
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hikma Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
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
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
Lead Product(s) : Oxytocin
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Monash University
Deal Size : Undisclosed
Deal Type : Agreement
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
RLD : No
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : No
TE Code :
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 :
Services
Analytical
Drug Product Manufacturing
Sales, Marketing, Registration
Packaging
Pharma Service : Packaging
Category : Contract Services
Sub Category : Blister
Pharma Service : Packaging
Pharma Service : Packaging
Category : Contract Services
Sub Category : Bottle
Pharma Service : Packaging
Pharma Service : Packaging
Category : Contract Services
Sub Category : Overview
Pharma Service : Packaging
Pharma Service : Packaging
Category : Contract Services
Sub Category : Serialization Compliance
Pharma Service : Packaging
API & Drug Product Development
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2009-09-18
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
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-04-02
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
District Decision : No Action Indicated
Inspection End Date : 2013-05-31
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
District Decision : No Action Indicated
Inspection End Date : 2015-06-19
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
District Decision : No Action Indicated
Inspection End Date : 2019-09-06
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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