Generic Products

Alan Laboratories, Inc. develops its own generic product pipeline. As of August 2018, one ANDA has been filed to FDA. Multiple products have passed bioequivalence test and will be filed to both FDA and CFDA.

The company is also working with partners in co-developing generic products. The collaboration model can be risk-share or fee-for-service. The company expects to generate sufficient revenue from FDA and CFDA approved generic products to cover the daily operation costs in the near future.

505(b)2 Products

The company also develops innovative formulations for existing drugs. These enhanced products fulfill unmet medical needs, and will be filed to FDA through 505(b)2 regulatory pathway.

There are three on-going projects: an abuse-deterrent long-acting release injectable in IND-enabling stage, a microsphere sustained-release formulation for diabetes foot ulcer management, and a long-acting release injectable for Parkinson’s disease. Two ophthalmology projects have been out-licensed to partner for further development.