09.18.19
Civica Rx and Exela Pharma Sciences have inked a long-term agreement to manufacture and supply Civica's growing membership of U.S. health systems with sodium bicarbonate injection, which has been in critically short supply in U.S. hospitals.
Exela, founded in 2005, recently received approval from the U.S. Food and Drug Administration (FDA) to manufacture sodium bicarbonate, which is used for emergency care in hospitals to treat metabolic acidosis which may be due to severe kidney disease, cardiac arrest, uncontrolled diabetes and circulatory insufficiency due to shock or severe dehydration. Civica member hospitals have prioritized sodium bicarbonate as an urgent medical need because they’ve had to ration use of the medication due to ongoing shortages.
Under the agreement, Exela will produce sodium bicarbonate for Civica, using Exela’s Abbreviated New Drug Application (ANDA) and Civica's labeling and National Drug Code (NDC). First deliveries to hospitals are expected this year.
“Exela continues to demonstrate its commitment to addressing shortages of this vital medication and we thank them for their partnership,” said Martin VanTrieste, president and chief executive officer, Civica Rx. “Sodium bicarbonate is a medicine that is a staple on hospital crash carts and often used for emergency resuscitations. No hospital or patient should ever have to go without it.”
Civica, founded last year by leading U.S. health systems and philanthropists, acts in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. To date, 39 health systems are Civica members, representing more than 1000 U.S. hospitals.
“We are pleased to be able to step in at this critical time and welcome the opportunity to work with Civica to ensure their member hospitals have sufficient supply of sodium bicarbonate,” said Phanesh Koneru, president and chief executive officer, Exela Pharma Sciences. “Collaborating to alleviate drug shortages is an important way to achieve our mission of providing access to affordable medicines.”
Exela, founded in 2005, recently received approval from the U.S. Food and Drug Administration (FDA) to manufacture sodium bicarbonate, which is used for emergency care in hospitals to treat metabolic acidosis which may be due to severe kidney disease, cardiac arrest, uncontrolled diabetes and circulatory insufficiency due to shock or severe dehydration. Civica member hospitals have prioritized sodium bicarbonate as an urgent medical need because they’ve had to ration use of the medication due to ongoing shortages.
Under the agreement, Exela will produce sodium bicarbonate for Civica, using Exela’s Abbreviated New Drug Application (ANDA) and Civica's labeling and National Drug Code (NDC). First deliveries to hospitals are expected this year.
“Exela continues to demonstrate its commitment to addressing shortages of this vital medication and we thank them for their partnership,” said Martin VanTrieste, president and chief executive officer, Civica Rx. “Sodium bicarbonate is a medicine that is a staple on hospital crash carts and often used for emergency resuscitations. No hospital or patient should ever have to go without it.”
Civica, founded last year by leading U.S. health systems and philanthropists, acts in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. To date, 39 health systems are Civica members, representing more than 1000 U.S. hospitals.
“We are pleased to be able to step in at this critical time and welcome the opportunity to work with Civica to ensure their member hospitals have sufficient supply of sodium bicarbonate,” said Phanesh Koneru, president and chief executive officer, Exela Pharma Sciences. “Collaborating to alleviate drug shortages is an important way to achieve our mission of providing access to affordable medicines.”
