Press Release
Approval of MAT in Mexico for Baqsimi® :
On April 24, 2023, Eli Lilly & Co. (“Lilly”) announced that it has entered into an definitive agreement for Lilly to divest BAQSIMI worldwide to Amphastar Pharmaceuticals, Inc. (“Amphastar”) a global pharmaceutical company focused on developing, manufacturing, and marketing injectable, intranasal, and inhalation products including experience with a glucagon product.
On September 20th, 2024, Global Regulatory Partners Mexico LLC, the designated local representative for Amphastar Inc. and the Baqsimi® Product in Mexico, received The notice of MAT Approval by COFEPRIS.
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.