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Polypharma Analgesic drug dossiers
End-to-end services provided by Polypharma Technologies & Sciences GmbH (Polypharma) include support for development of analgesic drugs.
Polypharma possesses an extensive portfolio of drug development dossiers that can be transferred to potential producers, providing them with a fast track way to develop medicines for home production to meet local market needs, particularly across Middle East and North Africa (MENA) markets.
Human medicine generic analgesic drugs
Analgesics such as paracetamol- and caffeine-based substances are in high demand worldwide for symptomatic treatment of pain of mild to moderate intensity as well as alleviating febrile conditions.
Polypharma pre-development includes fully documented scientific R&D exploration, along with support for development of DMF (Drug Master File) and registration procedure. For some analgesics, Polypharma has assembled all Quality, Safety and Efficacy information in Common Technical Document (CTD) format allowing harmonized electronic submission for faster regulatory approval.
These dossiers include analgesics, antipyretics and antispasmolytics including generic Codeine, Acetylsalicylic acid, Analgesic Caffeine, Mefenamic acid, Naproxene, Nefopam and Phloroglucinol. The most popular analgesics; Ibuprofen, Paracetamol, and Tramadol; are available in analgesic EU/CTD dossier form.
Polypharma has also developed a new oral formulation of Diclofenac.
Specific application of any particular dossier to local needs can be fully supported by Polypharma’s expert Research & Development Team.
Veterinary medicine analgesics
Polypharma also offers its partners across the MENA region a portfolio of analgesic drugs for veterinary medical applications, supported by high level of expertise and an array of pre-developed generic drug dossiers covering many therapeutic classes for all animals.
In the analgesics, anti-inflammatory and pain-killer class, veterinary generics include Chlorzoxazone, Diclofenac, Nimesulide and Paracetamol.
Polypharma is also able to develop new dossiers on request and after having carried out a specific feasibility study on the substance.