Lupin Limited has announced that its Japanese subsidiary Kyowa Pharmaceutical Industry Co., Ltd. and Astellas Pharma have entered into an agreement providing Kyowa the exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan. Astellas submitted a new drug application (NDA) with the Ministry of Health, Labour and Welfare in Japan for extended-release tablets of quetiapine fumarate for the indication of improvement of depressive symptoms associated with bipolar disorder.

When Astellas obtains an approval for the new drug application of extended-release tablets of quetiapine fumarate, based on the agreement, Kyowa will exclusively distribute and promote the products in Japan.

Dr Fabrice Egros, president – Asia Pacific & Japan, Lupin Limited commented, “Following Kyowa’s recent acquisition of long-listed products from Shionogi & Co., Ltd., the Astellas agreement reinforces Kyowa’s transition toward a hybrid pharmaceutical specialty care company and bolsters its leadership in the CNS space in Japan. Post regulatory approval for the product, we hope to bring to market a new solution for the treatment of depressive symptoms associated with bipolar disorder addressing unmet need for patients as well as provide additional treatment option for health care professionals in Japan.”

Founded in 1954, Kyowa Pharmaceutical Industry Co., Ltd. is a pharmaceutical company developing and manufacturing Branded & Generic pharmaceutical products for patients in the Japanese Market. With sales of JPY 25 billion for the fiscal year ended March 2016, Kyowa is amongst the fastest growing pharmaceutical companies in Japan, a market leader in the central nervous system - neurology space and has strong presence in cardiovascular, gastroenterology and injectable therapy segments.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.