About the programme
This product group is one of those facing supply constraints worldwide. Türkiye depends largely on imports in this area. With this programme we aim to build manufacturing capacity within the country.
Process steps
- Formulation and analytical development
- Phase 3 clinical study (under way)
- Marketing authorisation application to TİTCK
- Marketing authorisation
Rationale for the programme
Security of supply in this area is among national health policy priorities. This programme forms the basis of our work in immunology.
Immunology →About the programme
This is the higher-concentration equivalent of the 5% form. The two forms are being taken forward together under the same development programme.
Process steps
- Formulation and analytical development
- Phase 3 clinical study (under way)
- Marketing authorisation application to TİTCK
- Marketing authorisation
Rationale for the programme
Two different concentrations are being taken forward under a single development programme.
Immunology →About the programme
In this product group, supply in Türkiye rests largely on imports. The product is planned in two presentation volumes.
Process steps
- Formulation and analytical development
- Stability studies
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
This is our first marketing authorisation dossier in this area, and it shares the manufacturing and quality infrastructure on which our other programme rests.
Immunology →About the programme
This is our first development programme in uro-oncology and a direct extension of the experience we have built in urology.
Process steps
- Formulation and analytical development
- Bioequivalence study (accepted)
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
We aim to widen access to medicines where urology and oncology meet.
Oncology and haematology →About the programme
Among our nephrology programmes, this one covers the widest range of strengths.
Process steps
- Formulation and analytical development
- Six months of stability data completed
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
The number of oral treatment options in this area is limited in Türkiye.
Nephrology →About the programme
This formulation calls for prolonged-release technology and draws directly on our manufacturing experience in the same area.
Process steps
- Prolonged-release formulation development
- Six months of stability data completed
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
Lower urinary tract symptoms are common in the general population. This programme completes our urology product group.
Urology →About the programme
This is a granule formulation based on an ion-exchange resin, with demanding flow and dosing characteristics. It builds on the experience gained on our sachet and granulation line.
Process steps
- Granule formulation and analytical development
- Six months of stability data completed
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
Oral options containing this active substance are limited in Türkiye.
Nephrology →About the programme
Phenylketonuria is one of the rare metabolic diseases identified through the newborn screening programme in Türkiye. Small patient populations bring with them a responsibility for uninterrupted supply.
Process steps
- Soluble tablet formulation development
- Six months of stability data completed
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
In rare diseases, continuity of treatment is directly linked to security of supply.
Metabolic and rare diseases →About the programme
A two-strength programme to be manufactured on our film-coated tablet line.
Process steps
- Formulation and analytical development
- Six months of stability data completed
- Marketing authorisation application to TİTCK (under review)
- Marketing authorisation
Rationale for the programme
Anticoagulation is our first programme in haematology.
Oncology and haematology →