new product development
Douglas Pharmaceuticals has considerable expertise in the development and formulation of highly specialized products including Oratane (isotretinoin), Estelle/Cyprone (cyproterone acetate & ethinyloestradiol), Clopine (clozapine), Eltair/Aircort (budesonide nasal spray) and azathioprine.
Furthermore, we have taken these products to a number of markets as alternative brands supported by patient programmes and promotional material.
The company will continue to focus on the development of unique generics – in particular steroids and other niche products. The New Product Development Group occupies a state-of-the-art laboratory complex. This facility includes:
- Two pilot scale manufacturing plants (one fully dedicated to the manufacture of high potency products).
- Two instrument rooms (one has controlled lighting for the analysis of light-sensitive compounds).
- An office suite for documentation writing and data checking.
An essentially identical laboratory and manufacturing complex has also been built in Nadi, Fiji. Douglas Pharmaceuticals is working in collaborative research with a number of major pharmaceutical companies. These collaborations are of considerable importance to the company and will provide Douglas Pharmaceuticals with high level entry into the world’s major pharmaceutical markets.
Regulatory Expertise
Douglas Pharmaceuticals products are developed in full compliance with EU and other international guidelines and the company has teams specifically responsible for registration in New Zealand, Asia, Australia, Europe, the Americas and South Africa. With the New Zealand-European Community Mutual Recognition Agreement relating to GMP Inspection and Batch Certification of Medicinal Products in place, Douglas Pharmaceuticals is well positioned to provide toll manufacture at competitive prices and has moved rapidly to ensure new dossiers are compliant to CTD format.
Patent Advantages
Advantageous legislation in both New Zealand and Fiji allows Douglas Pharmaceuticals to develop any pharmaceutical molecule while still under patent.
Product Development
At Douglas Pharmaceuticals our expertise in the development and formulation of highly specialised products includes:
anastrozole 1 mg film coated tablets
azathioprine 50 mg film coated tablets
bicalutamide 50 mg film coated tablets
budesonide nasal spray
clozapine 25 mg, 50 mg, 100 mg and 200 mg tablets
clozapine 50 mg/mL suspension
cyproterone acetate 2 mg and ethinylestradiol 0.035 mg film coated tablets
cyproterone acetate 50 mg and 100 mg tablets
isotretinoin 5 mg, 10 mg, 20 mg and 40 mg soft gel capsules
quetiapine 25 mg, 100 mg, 200 mg and 300 mg film coated tablets
risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg film coated tablets
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