APL’s manufacturing follows current FDA and cGMP guidelines. All manufacturing and testing is fully documented using customized batch records and all process and analytical equipment is fully qualified and validated. All work is performed in qualified, Class 10,000 clean rooms in Austin Pharma’s FDA inspected facility.

Austin Pharma operations are supported by regulatory and quality assurance experts who are fully independent of production. Austin Pharma is well equipped to handle any FDA, DEA, or customer audit/inspection.

Austin Pharma will aid the drug development process by filing Drug Master Files to support any ANDA or NDA filing with the FDA, OGD, and EDQM for European submittals. Our expertise includes developing and validating analytical methods for compound and raw material release, and ensuring all manufacturing processes are validated in accordance with FDA expectations. APL is licensed by the U.S. Drug Enforcement Administration (DEA) to produce Schedule I, II and III controlled substances.

APL’s commercial manufacturing facility includes a state of the art Hastelloy reactor system capable of providing a wide range of synthetic parameters. Our expertise includes large scale, high performance liquid chromatography and our facility is equipped with a variety of chromatographic columns to provide low pressure chromatography to High Pressure large scale preparatory liquid chromatography. We are able to provide purification for high purity compounds in the multiple kilogram range. The purification system is supported by a customized, state of the art, automated solvent recovery system which allows for the removal of solvents from difficult compounds that are sensitive to heat and oxygen.

APL maintains a dry-pipe fire protection system for safety and long-term protection of the facility and customer interests. Production systems and building critical systems are supported by a 300KW Kohler diesel powered generator. Controlled substance storage is provided in APL’s six-sided UL listed Class-M and Class-1/DEA approved vault. APL’s facilities are controlled access with video surveillance. APL ensures Environmental Health and Safety (EHS) policies and procedures are maintained in compliance with applicable federal, state and local EHS laws and regulations.