Generic drugs dossier development
Polypharma is the ideal partner for manufacturers who are considering expanding their generics production line or establishing a new production site.
To date, Polypharma has developed a large number of dossiers, covering all dosage forms, according to the specific requirements or needs of generic drugs manufacturers. As part of our ongoing customer care, we also offer dossier updates.
On request, we are ready to study the possibility of developing new dossiers.
DMFs for APIs
We develop API Drug Master Files (DMF) in cooperation with manufacturers.
Each manufacturing dossier is accompanied by the regulatory documentation required for the registration of the finished product with the health authorities of the country in order to obtain the market approval.
Dossier portfolio for generics of any pharmaceutical formulation
The dossier and their pharmaceutical forms are as follows:
- Vaginal suppositories
- Solutions for injection
- Nasal sprays and drops
Oral solutions and suspensions