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Polypharma generic drug Dossier Development Service for MENA markets
End-to-end services provided by Polypharma Technologies & Sciences GmbH (Polypharma) include dossier development for generic medicines for Middle East and North Africa (MENA) markets.
This service provides MENA drug companies without their own R&D departments with the possibility of registering and producing innovative and classic generics to overcome drug supply problems and counterfeiting problems in these markets.
Dossier Development Service features
Polypharma developed its drug dossier service based on extensive market research and consultations across the MENA region, which revealed that these markets tend to exhibit lack of production capacity and are moreover poorly served by European and American based manufacturers.
Whenever a target medicine or drug is identified, Polypharma can support a drug production partner in developing a tailored generic drug dossier to match that need and be available for local registration.
Polypharma is able to develop drug submission dossiers and drug master files (DMFs) that include all the technical data demanded by regulators. These include:
- Unit composition and manufacturing formula
- Manufacturing equipment & process
- Quality control of active ingredient (specifications, analytical methods)
- Quality control of excipients (specifications, analytical methods)
- Quality control of the finished product (specifications, analytical methods)
- Stability Data.
From Development to Production
Once the dossier and DMF are accepted, Polypharma can also provide tech-transfer to accelerate production at the partner’s own production facility, as well as a full service to move partner from development to full scale production (see Resources). This can include:
- Providing all raw material documentation required for registration
- Working together with a new partner to provide all necessary information to meet legal provisions
- Delivery of all needed pharmaceutical raw materials for each finished dosage form
- Working together to provide the local market with high quality generic drugs
- Core competencies of Polypharma include project planning, feasibility studies, technology transfer, pharmaceutical development, and materials sourcing and supply
Polypharma Full Service offerings can include all these elements and more to provide a total solution for pharmaceutical developers and producers that can also include processing registrations, with on-site services that include all necessary API-manufacturer documentation, such as GMP, CPP, manufacturing license, and DMFs.
Dossier Development Service benefits
Polypharma’s Dossier Development Service is based on the company’s many years of experience in advising generic manufacturers in Northern, Western and Eastern Africa, as well as in the Middle East.
It can play a key role in enabling local partners in rapidly responding to supply shortages, therapeutic gaps and consequent market opportunities.
In particular, it provides production partners with access to Polypharma’s extensive panel of pre-developed generics and biosimilars without having to outsource production to a CDMO.
Click on Polypharma Generic Drug Dossier Development for more information.
Click on Polypharma Tech Transfer for further information on production support.
Click on Polypharma Full Service to Production for further information on production support.
Click on Polypharma portfolio of generic drugs for further information.