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CPhI India 2024CPhI India 2024
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26-28 November, 2024
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11-14 November, 2024
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11-13 November, 2024
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CPhI India 2024CPhI India 2024
Industry Trade Show
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26-28 November, 2024
Industry Trade Show
Not Confirmed
11-14 November, 2024
The Pharmacy Technolog...The Pharmacy Technology
Industry Trade Show
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11-13 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients
VLOG #PharmaReel
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[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities
28 Aug 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/germanys-stada-reports-rosy-earnings-first-half-2024-ceo-tempers-sales-rumors
22 Jul 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/07/22/2916396/0/en/STADA-and-Alvotech-launch-Uzpruvo-the-first-approved-ustekinumab-biosimilar-to-Stelara-across-Europe.html
12 Jun 2024
// PRESS RELEASE
https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-stada-add-strategic-alliance-through-denosumab
31 May 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/calliditas-partner-stada-receives-positive-chmp-opinion-recommending-full-approval-for-kinpeygo-for-the-treatment-of-iga-nephropathy-302159841.html
10 May 2024
// ENDPTS
https://endpts.com/iteos-to-raise-120m-xbrane-and-stada-to-out-license-lucentis-biosimilar/
10 Jan 2024
// GLOBENEWSWIRE
https://www.globenewswire.com//news-release/2024/01/10/2806857/0/en/STADA-and-Alvotech-Secure-Approval-for-Uzpruvo-Europe-s-First-Ustekinumab-Biosimilar-to-Stelara.html
Details:
Kinpeygo (budesonide)is a modified-release capsule, glucocorticoid receptor agonist, which is indicated for the treatment of patients with primary IgA nephropathy.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Brand Name: Kinpeygo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2024
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Calliditas’ STADA Receives EC Decision for Full Approval of Kinpeygo® in IgA Nephropathy
Details : Kinpeygo (budesonide)is a modified-release capsule, glucocorticoid receptor agonist, which is indicated for the treatment of patients with primary IgA nephropathy.
Brand Name : Kinpeygo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 26, 2024
Details:
Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Brand Name: Uzpruvo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Alvotech
Deal Size : Not Applicable
Deal Type : Not Applicable
STADA and Alvotech Launch Uzpruvo, First Ustekinumab Biosimilar to Stelara in Europe
Details : Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Brand Name : Uzpruvo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 22, 2024
Details:
The partnership aims to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Brand Name: AVT03
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 11, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Recipient : Alvotech
Deal Size : Undisclosed
Deal Type : Partnership
Alvotech and STADA Add to Strategic Alliance Through Denosumab Partnership
Details : The partnership aims to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
Brand Name : AVT03
Molecule Type : Large molecule
Upfront Cash : Undisclosed
June 11, 2024
Details:
Under the agreement, Bio-Thera Solutions will maintain responsibility for development, manufacturing, and supply of BAT2506, a biosimilar candidate to Simponi® (golimumab).
Lead Product(s): Gollmumab
Therapeutic Area: Immunology Brand Name: BAT2506
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Bio-Thera Solutions
Deal Size: $157.5 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement May 28, 2024
Lead Product(s) : Gollmumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Recipient : Bio-Thera Solutions
Deal Size : $157.5 million
Deal Type : Licensing Agreement
Bio-Thera and STADA Reach Agreement for BAT2506 Biosimilar in the EU and UK
Details : Under the agreement, Bio-Thera Solutions will maintain responsibility for development, manufacturing, and supply of BAT2506, a biosimilar candidate to Simponi® (golimumab).
Brand Name : BAT2506
Molecule Type : Large molecule
Upfront Cash : $10.0 million
May 28, 2024
Details:
Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Lead Product(s): Ustekinumab
Therapeutic Area: Gastroenterology Brand Name: Uzpruvo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Alvotech
Deal Size : Not Applicable
Deal Type : Not Applicable
STADA and Alvotech Secure Approval for Uzpruvo, Europe's First Ustekinumab Biosimilar
Details : Uzpruvo (ustekinumab-biosimilar) is a human IgG1κ monoclonal antibody (mAb) which inhibits IL-12 & Il-23. It is approved by EMA for the treatment of crohn’s disease, psoriasis and psoriatic arthritis.
Brand Name : Uzpruvo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 10, 2024
Details:
Uzpruvo (ustekinumab) biosimilar candidate to Stelara is a human IgG1κ monoclonal antibody (mAb), which is investigated for the treatment of moderate to severe chronic plaque-type psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: Uzpruvo
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Uzpruvo (ustekinumab) biosimilar candidate to Stelara is a human IgG1κ monoclonal antibody (mAb), which is investigated for the treatment of moderate to severe chronic plaque-type psoriasis.
Brand Name : Uzpruvo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 10, 2023
Details:
Ximluci (ranibizumab) binds and inhibits VEGF-A, including VEGF110, preventing the interaction of VEGF-A with VEGFR1 and VEGFR2 on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Brand Name: Ximluci
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Xbrane Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2023
Lead Product(s) : Ranibizumab
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Xbrane Biopharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Stada and Xbrane Obtain British Approval for Ximluci® (ranibizumab) Biosimilar Referencing Lucent...
Details : Ximluci (ranibizumab) binds and inhibits VEGF-A, including VEGF110, preventing the interaction of VEGF-A with VEGFR1 and VEGFR2 on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation...
Brand Name : Ximluci
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 16, 2023
Details:
Hukyndra (adalimumab) is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor. Adalimumab is first product launched through an exclusive strategic partnership announced by Alvotech and STADA in November 2019.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Brand Name: Hukyndra
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Alvotech
Deal Size : Not Applicable
Deal Type : Not Applicable
Alvotech and STADA Broaden Access to Hukyndra® Adalimumab Biosimilar in Europe
Details : Hukyndra (adalimumab) is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor. Adalimumab is first product launched through an exclusive strategic partnership announced by Alvotech and STADA in November 2019...
Brand Name : Hukyndra
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 07, 2022
Details:
Hukyndra (adalimumab), Hukyndra is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor, increases availability of high-concentration, low-volume, citrate-free presentations of adalimumab.
Lead Product(s): Adalimumab
Therapeutic Area: Immunology Brand Name: Hukyndra
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Alvotech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Lead Product(s) : Adalimumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Recipient : Alvotech
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Hukyndra (adalimumab), Hukyndra is a monoclonal antibody and a biosimilar to Humira® (adalimumab) that inhibits tumor necrosis factor, increases availability of high-concentration, low-volume, citrate-free presentations of adalimumab.
Brand Name : Hukyndra
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 22, 2022
Details:
Nefecon (budesonide) is a patented novel, investigational oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the ileum where the Peyer’s patches are concentrated.
Lead Product(s): Budesonide
Therapeutic Area: Nephrology Brand Name: Nefecon
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Calliditas Therapeutics AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Lead Product(s) : Budesonide
Therapeutic Area : Nephrology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Calliditas Therapeutics AB
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Nefecon (budesonide) is a patented novel, investigational oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the ileum where the Peyer’s patches are c...
Brand Name : Nefecon
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 20, 2022
Regulatory Info :
Registration Country : Italy
Dosage Form : Film-Coated Tablets
Brand Name : ACECLOFENAC EG
Dosage Strength : 100 mg
Packaging : 40 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name : Aceclofenac Stada 100Mg 2...
Dosage Strength : 100 Mg/Tablet
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name : Aceclofenac Stada 100Mg 4...
Dosage Strength : 100 Mg/Tablet
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name : Aceclofenac Stada Generic...
Dosage Strength : 100 Mg/Tablet
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name : Aceclofenac Stada Generic...
Dosage Strength : 100 Mg/Tablet
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Brand Name : Tianzakt
Dosage Strength : 100 MG
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Dosage Form : Gastro-Resistant Tablets
Brand Name : ACETYLSALICYLIC ACID EG
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Brand Name : acyclovir Tablets
Dosage Strength : 800 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Brand Name : acyclovir Tablets
Dosage Strength : 200 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Brand Name : acyclovir Tablets
Dosage Strength : 400 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Dosage Strength : 100 Mg/Tablet
Packaging :
Brand Name : Aceclofenac Stada Generic 100...
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Dosage Strength : 100 Mg/Tablet
Packaging :
Brand Name : Aceclofenac Stada 100Mg 20 Co...
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Dosage Strength : 100 Mg/Tablet
Packaging :
Brand Name : Aceclofenac Stada Generic 100...
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Dosage Strength : 100 Mg/Tablet
Packaging :
Brand Name : Aceclofenac Stada 100Mg 40 Co...
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Dosage Form : Film-Coated Tablets
Dosage Strength : 100 mg
Packaging : 40 UNITS 100 MG - ...
Brand Name : ACECLOFENAC EG
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Dosage Strength : 100 MG
Packaging :
Brand Name : Tianzakt
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Dosage Form : Gastro-Resistant Tablets
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ...
Brand Name : ACETYLSALICYLIC ACID EG
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Dosage Strength : 800 MG
Packaging :
Brand Name : acyclovir Tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Dosage Strength : 400 MG
Packaging :
Brand Name : acyclovir Tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Dosage Strength : 200 MG
Packaging :
Brand Name : acyclovir Tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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