Press Release
NOTICE - Sucession of BAQSIMIⓇ Nasal Powder 3mg”in Japan :
In April 2023, Eli Lilly and Company (headquartered in Indianapolis USA; hereinafter referred to as “Lilly”) and Amphastar Pharmaceuticals (headquartered in California USA; hereinafter referred to as “Amphastar”), Inc. announced that they have entered into an agreement for Lilly to divest the worldwide marketing authorization for BAQSIMIⓇ to Amphastar, a global pharmaceutical company focused on developing, manufacturing, and marketing of injectable, intranasal, and inhalation products including experience with a glucagon product.
Subsequently, the transfer of marketing rights of BAQSIMI® in Japan had also been considered, as a result of the recent agreement between Amphastar and Global Regulatory Partners, Inc. (headquartered in Massachusetts, USA), Amphastar entered into an agreement with GRP Japan to become the Marketing Authorization holder of BAQSIMI® in Japan and the completion of the transfer. As a result of this, Eli Lilly Japan will transfer the marketing authorization for BAQSIMIⓇ in Japan to GRP Japan.
As a result of this, for providing the appropriate product’s information and will be responding to any questions related to BAQSIMIⓇ in Japan, Eli Lilly Japan will be responsible until December 30, 2024, and GRP Japan will start to be responsible from December 31st 2024.
Both companies are committed to ensure that this transfer does not present any inconvenience to patients or healthcare professionals.
About Baqsimi® :
Baqsimi® is a glucagon nasal powder that Lilly launched in 2019 as an option to quickly render aid in rescue situations for people with diabetes who take insulin and it is currently available in 27 international markets. Baqsimi was approved in Mexico in 2021. Baqsimi® is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.
About Global Regulatory Partners Group
Global Regulatory Partners, Inc (GRP) is a global provider of tailored clinical development, regulatory affairs, quality and pharmacovigilance services for pharma, biotech, medical devices and cosmetic industries worldwide.
Global Regulatory Partners. Inc, has now over 500 employees, 6 affiliates in 6 countries (USA, Brazil, Mexico, Japan, China and South Korea) and more than 500 satisfied clients worldwide.
In China, GRP-China has offices in three locations, Shanghai, Beijing and Hainan, and has local teams of Regulatory Affairs, Clinical Development ,Quality and Pharmacovigilance professionals, who support the clinical development and products’ registration of many pharmaceutical and medical device companies in Hainan pilot zone and in China Mainland as well.