Controlled Substances Manufacturing
Licensed manufacturing of controlled substance, drug substance, oral liquids and injectable drug products. The licence, the infrastructure, and the commercial track record are already in place.
What We Handle
Licensed and Operational
Active AU Schedule 8 controlled substance manufacturing license — Schedule II in the US and Schedule 2 in the UK — licensed, operational, and embedded in daily manufacturing practice.
01
Vault Storage and Security
Dedicated vault storage for controlled substance raw materials and finished product. Diversion controls and surveillance systems embedded throughout the manufacturing environment.
02
Chain of Custody
Full chain of custody documentation maintained throughout receipt, manufacture, storage, and dispatch. Government regulatory reporting as standard operational practice.
03
Trained and Cleared Personnel
All staff handling controlled substance compounds are trained and cleared. Controlled substance handling protocols applied at every stage of manufacture.
04
Manufacturing Formats
Controlled substance programs are supported across BioCina's full drug product manufacturing platform. The appropriate manufacturing format is selected based on your molecule, dosage form, and regulatory strategy.
Farmomac liquid filling line. Fill volumes 10 to 250 mL. Amber PET and HDPE bottles with tamper-evident, child-resistant closures. Controlled substance oral liquid products (i.e. morphine oral solution) manufactured commercially on this line.
Explore Oral Liquids
From Development to Commercial Supply
Feasibility and License Verification
Compound-specific feasibility assessment and licence verification for the specific substance, product format, and target market.
Development and Clinical Manufacture
Formulation and process development under licensed, GMP-controlled conditions. Analytical method development and validation. GMP clinical batch manufacture with full chain of custody documentation and CMC regulatory submission support.
Commercial Scale and Dispatch
Commercial scale-up under ongoing licence compliance and government reporting. QC release with full controlled substance documentation and dispatch records. Products prepared for ex-works dispatch.
Programs We Support
Controlled Oral Liquids
Opioid and specialty oral liquid programs for pain management, palliative care, addiction treatment, and neurological supply.
Controlled Injectables
Sterile injectable programs requiring licensed manufacture and full chain of custody.
Did you know manufacturing in Australia could fund nearly half your program?
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Drug Product Manufacturing Track Record
0+ years
of Sterile Manufacturing Heritage
0M+ units
Annual Capacity
0+
Approved Products
0+
Countries Delivered
Ready to Start Your Controlled Substance Program?
Our team is ready to discuss your formulation, licensing requirements, and path to supply.