Newport Pharmaceuticals International
Newport Pharmaceuticals Limited (Ireland) operates as a corporate support centre within the Ewopharma Group. The company manages outsourced drug substance and drug product manufacture, formulation development, batch release and international distribution for its lead compound and partner products. It provides regulatory, quality assurance, pharmacovigilance, compliance and commercial market-access services focused on Switzerland and Central and Eastern Europe.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Inosine Acedoben Dimepranol (IAD)
A synthetic purine derivative used as an immunomodulator indicated for treatment of cell-mediated immune deficiencies associated with viral infections. Manufactured as a drug substance and supplied to partner organisations for marketing in multiple countries.
Inosine Acedoben Dimepranol (IAD)
A synthetic purine derivative used as an immunomodulator indicated for treatment of cell-mediated immune deficiencies associated with viral infections. Manufactured as a drug substance and supplied to partner organisations for marketing in multiple countries.
Services
Management of outsourced manufacture, packaging, testing and international distribution of drug substance and drug product.
Preparation and submission of product dossiers, DMFs, license management and representation to regulatory authorities.
Operation of a Quality Management System covering GMP/GDP and oversight of batch release processes.
Processing and reporting of safety information and provision of medical/scientific information and education for marketed products.
Implementation and monitoring of compliance programmes, risk assessments, audits, and provision of in-house legal counsel.
Commercialisation support including market entry, pricing, reimbursement, sales & marketing and distribution in CEE and Switzerland.
Management of outsourced manufacture, packaging, testing and international distribution of drug substance and drug product.
Preparation and submission of product dossiers, DMFs, license management and representation to regulatory authorities.
Operation of a Quality Management System covering GMP/GDP and oversight of batch release processes.
Processing and reporting of safety information and provision of medical/scientific information and education for marketed products.
Implementation and monitoring of compliance programmes, risk assessments, audits, and provision of in-house legal counsel.
Commercialisation support including market entry, pricing, reimbursement, sales & marketing and distribution in CEE and Switzerland.
Expertise Areas
- Manufacturing and supply chain management for pharmaceuticals
- Formulation development and manufacturing process optimisation
- Regulatory affairs and dossier/DMF preparation
- Quality assurance and GMP/GDP compliance
Key Technologies
- GMP manufacturing
- Formulation development
- Regulatory dossier and DMF preparation
- Pharmacovigilance systems and safety reporting
News & Updates
Press release announcing a commercial collaboration to gain commercial rights for an anti-PD-L1 monoclonal antibody in Switzerland and 18 Central Eastern European countries; covers commercial and regulatory terms.
Announcement that an existing distribution agreement was expanded to include a pancreatic cancer indication under the same commercial and milestone terms.
Press release describing the acquisition of AllergyCare AG by the Ewopharma Group to strengthen presence in the Swiss market for allergy-focused consumer health and pharmaceutical distribution.
Press release announcing the acquisition of a Czech distribution company to establish a logistics hub and expand distribution capabilities in the region.
Press release announcing a commercial collaboration to gain commercial rights for an anti-PD-L1 monoclonal antibody in Switzerland and 18 Central Eastern European countries; covers commercial and regulatory terms.
Announcement that an existing distribution agreement was expanded to include a pancreatic cancer indication under the same commercial and milestone terms.
Press release describing the acquisition of AllergyCare AG by the Ewopharma Group to strengthen presence in the Swiss market for allergy-focused consumer health and pharmaceutical distribution.
Press release announcing the acquisition of a Czech distribution company to establish a logistics hub and expand distribution capabilities in the region.