Dossier development

Development of generic drugs dossiers

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:

  • Tablets
  • Capsules
  • Inhalation
  • Suppositories
  • Vaginal suppositories
  • Solutions for injection
  • Infusions
  • Nasal sprays and drops
  • Eye drops

  • Syrups

  • Oral solutions and suspensions

  • Creams

  • Ointments

  • Gels

  • Patches

You can access our dossier list by clicking on human medicine or veterinary medicine.

 

*A bioequivalence study can be made upon request, which will lead to supplementary costs.

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Polypharma
Technologies & Sciences GmbH

Grosse Reichenstrasse 27
20457 Hamburg
Germany
+49 (0)40 37 480 3-0
info[at]polypharma.de