Rich Pharmaceuticals, Inc. announced that it has competed a GMP clinical batch of RP-323 study drug that was manufactured at the Wuxi Apptec Biopharmaceutical's facility based in Shanghai, China. This new batch of RP-323 represents a new second-generation compound with improved product usability and stability. Rich Pharmaceuticals developed the new formulation and all regulatory required testing methods in 2014 and transferred the proprietary technology successfully to Wuxi Apptec for the GMP production of RP-323.

Currently, the new study drug is in the final examination stage at Wuxi Apptec and is expected to be shipped to clinical sites starting mid-February 2015 for the upcoming planned clinical trials. Rich Pharmaceuticals submitted its Investigational New Drug (IND) Application for a Phase 2 multi-center study to evaluate the safety and efficacy of RP-323 in patients with AML and MDS in October 2014. In connection with the IND, Rich Pharmaceuticals was required to manufacture sufficient quantities of RP-323 under GMP.