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pp-107

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Progressive supranuclear palsy (PSP), a rare, rapidly progressing tau‑associated neurodegenerative disorder in adults Clinical stage: Phase 2 clinical development with topline recruitment completed Modality: Small molecule Mechanism / Target: Selective O‑GlcNAcase (OGA) enzyme inhibition to increase tau O‑GlcNAcylation and potentially reduce pathological tau aggregation Route / form: Oral administration (tablet) Differentiation: Brain‑penetrant OGA inhibitor targeting tau pathology with potential disease‑modifying effects in PSP where no approved therapies exist
Manufacturer #12186
The activity of the company is based on the development of highly competitive processes for the manufacture of active ingredients with high added value that meet the strictest quality specifications. They manufacture under strict compliance with the environmental and occupational safety regulations in force in Europe. They focus on the pharmaceutical, hospital, diagnostic, fine chemical, and food fields. Its products are marketed in more than 70 countries.

Manufacturer usually replies in 2 days

pp-036

Nebuliser solution

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Bronchiolitis obliterans syndrome, specifically in lung transplant patients, targeting a progressive rare inflammatory lung disease. Phase III; Inhaled liposomal formulation of cyclosporine A, delivering immunosuppression/anti-inflammatory action directly to the lung airways to halt fibrotic destruction of small airways. Unique inhaled immunosuppressive approach for BOS — no approved treatment for this indication currently.
Manufacturer #570

A pharmaceutical manufacturer based in the EU that has been active in 80+ countries selling its products for 110+ years. Main therapeutic areas include CNS, respiratory, and women’s health. Main dosage forms include sterile drugs, solid oral, and liquid forms. The company owns 20+ branches in Europe, North America, and Asia. The company possesses manufacturing facilities in Europe, Asia, and LATAM.

Manufacturer usually replies in 45 days

pp-262

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Psychiatric disorder, Major depressive disorder, Depression Clinical stage: Phase 3 Modality: Small molecule Mechanism & Target: CNS modulator Route & form: Oral Differentiation: This is a first–in–class triple reuptake inhibitor that simultaneously targets the serotonin, norepinephrine and dopamine transporters.
Manufacturer #39676

A late-stage clinical biopharmaceutical company focused on unmet medical needs. Developing a small molecule therapeutic targeting unmet medical needs with global development focus. Pipeline positioned for regulatory advancement in key markets.

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