Alkaloids
Manufacturer and exporter of hyoscine (scopolamine) APIs and intermediates. Operations are vertically integrated from cultivated Duboisia hybrids through automated extraction, purification and GMP production to packaging and global distribution. Facility licensed by the Australian Therapeutic Goods Administration since 1991, holds GMP certifications (including ANVISA), a CEP for one API (since 2016) and an ASMF for regulatory filings. Production commenced in 1987 and the company exports to over 50 countries.
Industries
Nr. of Employees
small (1-50)
Alkaloids
Edgecliff Centre, Level 5, 203-233 New South Head Road, Edgecliff NSW 2027, Australia
Patents
Products
Hyoscine Butylbromide (scopolamine butylbromide) API
Active pharmaceutical ingredient produced to meet European Pharmacopoeia specifications; supplied as a finished API with certificates of analysis.
Hyoscine Hydrobromide (scopolamine hydrobromide) intermediate
Intermediate material produced and tested to European Pharmacopoeia standards for use in downstream API manufacture.
Hyoscine Butylbromide (scopolamine butylbromide) API
Active pharmaceutical ingredient produced to meet European Pharmacopoeia specifications; supplied as a finished API with certificates of analysis.
Hyoscine Hydrobromide (scopolamine hydrobromide) intermediate
Intermediate material produced and tested to European Pharmacopoeia standards for use in downstream API manufacture.
Expertise Areas
- Active pharmaceutical ingredient (API) manufacturing
- Botanical raw material cultivation and processing
- Pharmaceutical quality control and pharmacopoeial compliance
- Regulatory dossier management for APIs (ASMF, CEP)
Key Technologies
- Continuous automated extraction processes
- GMP production facilities and controlled manufacturing lines
- Chemical isolation and purification methods
- Pharmacopoeial analytical testing methods (EP compliance)
News & Updates
Manufacturing operations commenced in 1987; facility focused on hyoscine derivatives since that time.
Operation first licensed by the Australian Therapeutic Goods Administration for manufacturing in 1991; licence has been continuously held.
Certificate of Suitability (CEP) for hyoscine butylbromide held with the European Directorate for the Quality of Medicines since 2016.
Exports products to over 50 countries across Asia, Europe, the Americas, the Indian subcontinent, the Middle East and Africa.
Manufacturing operations commenced in 1987; facility focused on hyoscine derivatives since that time.
Operation first licensed by the Australian Therapeutic Goods Administration for manufacturing in 1991; licence has been continuously held.
Certificate of Suitability (CEP) for hyoscine butylbromide held with the European Directorate for the Quality of Medicines since 2016.
Exports products to over 50 countries across Asia, Europe, the Americas, the Indian subcontinent, the Middle East and Africa.