Shanghai Pharma's aripiprazole approved for sale in Philippines

Shanghai Pharmaceuticals Holding Co., Ltd. (Shanghai Pharma) announced its subsidiary, Shanghai Sine Pharmaceutical Co., Ltd., has received a drug registration certificate from the Philippine Food and Drug Administration for its 10 mg aripiprazole tablets. This approval allows the drug to be marketed in the Philippines. The company invested approximately RMB 50,000 in registration-related fees for this market entry.

Aripiprazole tablets, a chemical drug, are indicated for the treatment of schizophrenia, manic episodes of bipolar I disorder, and as an adjunct for depression. The drug was originally developed by Bristol-Myers Squibb and Otsuka Pharmaceutical, first approved by the US FDA in November 2002. Shanghai Sine Pharmaceutical's aripiprazole tablets were approved in China in October 2004, and its 5mg strength passed generic consistency evaluation in March 2021.

As of the announcement date, the Philippine market for 10 mg aripiprazole tablets generated $2.39m in sales in 2024, according to IQVIA data, with five other existing distributors. Shanghai Pharma expects this approval to positively impact its expansion into overseas markets, while acknowledging potential risks such as policy changes, exchange rate fluctuations, and market competition.