Gland Pharma Announces Launch of the First Novel Non-Frozen Ready-To-Use Bivalirudin

View pdf

GLAND PHARMA Ltd. (Gland Pharma), along with its partners MAIA Pharmaceucals, Inc. (MAIA) and Athenex Pharmaceucal Division (APD) announce the launch of a Ready-to-Use (RTU) Bivalirudin Injecon in the United States of America. This is the first non-frozen ready-to-use bivalirudin 505b(2) NDA approved by the U.S. Food and Drug Administraon (USFDA).

Bivalirudin RTU Injecon is indicated for use as an ancoagulant in paents undergoing percutaneous coronary intervenon (PCI), including paents with heparin-induced thrombocytopenia and heparininduced thrombocytopenia and thrombosis syndrome.

Bivalirudin RTU Injecon is available to order from APD in a 250mg/50mL (5mg/mL concentraon) Piggyback Vial.

The product is manufactured by Gland Pharma Ltd. (Gland), a globally renowned manufacturer of Small Volume Parenterals (SVPs) located in India.

“We are pleased to collaborate with MAIA and Athenex in bringing to market the RTU non-Frozen Version of Bivalirudin Injecon. We believe that this complements our commitment to provide Easy to Use, Safe to Deliver, Cost Effecve Products to clinicians” said Srinivas Sadu, MD and CEO of Gland Pharma Limited.

“We are delighted to introduce a unique RTU Bivalirudin Injecon that does not require frozen storage into the US hospital market,” said Jeffrey Yordon, Athenex's Chief Operang Officer. “The launch of this innovave product underlines the unique ability of Athenex to work quickly and collaboravely to bring much needed products to our customers. We'd like to thank our partners at MAIA and Gland for matching our agility, enabling our speed to market, and supporng our unwavering commitment to delivering high-quality products that can help address our customers' ongoing needs.”

Srikanth Sundaram, Ph.D., President of MAIA, added, “We are thrilled with the launch of MAIA's NDA product in partnership with the seasoned and exceponal team at Athenex and Gland. Bivalirudin RTU Injecon, which does not need reconstuon and further diluon unlike the lyophilized version, essenally eliminates the drug preparaon process. By avoiding potenal errors in the drug preparaon and administraon process and associated adverse events, its use offers benefits to the paent.”

About Gland Pharma: Established in Hyderabad, India in 1978, Gland Pharma is one of the fastest growing small molecule generic injectables-focused company, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets in Rest of the world. Gland Pharma has seven manufacturing facilies in India, comprising four facilies for finished formulaons and three API facilies. We are focused on meeng diverse injectables needs with a stable supply of affordable and high quality products. We have established a porolio of injectables products across various therapeuc segments and delivery systems and are present in sterile injectables, oncology and ophthalmics with focus on complex injectables.