Mapi Pharma
Mapi Pharma is a clinical stage pharmaceutical company focused on developing complex active pharmaceutical ingredients, long-acting depot injections, and formulations. The company aims to meet unmet patient needs with innovative long-acting treatments, particularly for multiple sclerosis, and has a strong pipeline of products including GA Depot for MS. Mapi is committed to high-quality R&D, regulatory compliance, and strategic partnerships to bring advanced therapies to large markets.
Industries
Nr. of Employees
small (1-50)
Mapi Pharma
Products
Long-acting intramuscular depot formulation of glatiramer acetate (once-monthly injection)
An extended-release intramuscular formulation of glatiramer acetate designed for administration once every four weeks; advanced through Phase II/III clinical development with randomized, placebo-controlled pivotal data.
Complex API process technologies and process patents (examples: fingolimod, tapentadol)
Process chemistry and intermediate compound development for complex APIs, with granted patents covering intermediate compounds and scalable synthetic routes.
Long-acting intramuscular depot formulation of glatiramer acetate (once-monthly injection)
An extended-release intramuscular formulation of glatiramer acetate designed for administration once every four weeks; advanced through Phase II/III clinical development with randomized, placebo-controlled pivotal data.
Complex API process technologies and process patents (examples: fingolimod, tapentadol)
Process chemistry and intermediate compound development for complex APIs, with granted patents covering intermediate compounds and scalable synthetic routes.
Services
Contract aseptic fill & finish and sterile manufacturing
Clinical and commercial sterile filling and finishing services for liquid and powder injectables, including capacity for vaccine fill & finish and audited GMP production.
Formulation development for long-acting depot injectables and oral ER products
Preclinical and clinical formulation development for extended-release depot injections and complex oral extended-release products, including small-scale manufacturing for IND-enabling studies.
API process development and commercial scale-up
Route scouting, intermediate synthesis, pilot production and scale-up to mid-scale commercial reactors; development of cost-effective, scalable synthetic routes.
Clinical development management and regulatory support
End-to-end clinical program management for pivotal trials, regulatory strategy for 505(b)(2) and NDA filings, and coordination for multinational trials.
Partnership, licensing and co-development
Structuring and executing co-development and commercialization agreements, including milestone-based funding and licensing arrangements for global and regional markets.
Contract aseptic fill & finish and sterile manufacturing
Clinical and commercial sterile filling and finishing services for liquid and powder injectables, including capacity for vaccine fill & finish and audited GMP production.
Formulation development for long-acting depot injectables and oral ER products
Preclinical and clinical formulation development for extended-release depot injections and complex oral extended-release products, including small-scale manufacturing for IND-enabling studies.
API process development and commercial scale-up
Route scouting, intermediate synthesis, pilot production and scale-up to mid-scale commercial reactors; development of cost-effective, scalable synthetic routes.
Clinical development management and regulatory support
End-to-end clinical program management for pivotal trials, regulatory strategy for 505(b)(2) and NDA filings, and coordination for multinational trials.
Partnership, licensing and co-development
Structuring and executing co-development and commercialization agreements, including milestone-based funding and licensing arrangements for global and regional markets.
Expertise Areas
- Long-acting injectable development
- Clinical trial management (Phase II/III)
- Complex API synthesis and scale-up
- Sterile manufacturing and aseptic fill & finish
Key Technologies
- Sustained-release depot injectable formulations
- Intramuscular depot delivery
- Aseptic fill & finish technology
- Design of Experiments (DoE)