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Polypharma generic alkaloid drug dossier development
Polypharma Technologies & Sciences GmbH (Polypharma) is able to provide a wide range of pre-developed dossiers for generic human and animal medicines to save time and money for producers in the 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.
The range of Polypharma developed dossiers includes many in the alkaloid-based classes widely applicable across therapeutic areas like rheumatology, anesthesia, and analgesics.
Polypharma has already developed dossiers in many classes of human and veterinary medicine. These drug submission dossiers and drug master files (DMFs) include all the technical data demanded by regulators, such as:
- 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.
In human medicine, the Polypharma portfolio of developed alkaloid drug dossiers includes:
- Analgesic (including Antipyretic and Antispasmolytic): Polypharma has developed dossiers for Caffeine, Codeine in association with other APIs.
- Anesthesia & Reanimation: Dossiers developed for Atropine, Ephedrine
- Oto-Rhino-Laryngology: Polypharma has developed dossiers for Pseudoephedrine hydrochloride in association with other APIs
- Rheumatology: Developed dossiers available for Diclofenac, Thiocolchicoside
Dossier Development Service
Polypharma developed its drug dossier service based on extensive market research and client 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 is identified, including alkaloid drugs and cardioprotectives, Polypharma can support a drug production partner in developing a tailored generic drug dossier to match that need and be available for local registration.
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.
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 without having to outsource production to a CDMO.