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Voluntary Class I RECALL – Dispensing Level – Initiated 10/19/23 Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL due to the Presence of Particulate Matter Microsoft Word Doc
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Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022
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Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage
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PREMIER INC. and 11 Leading Health Systems Invest in EXELA Pharma Sciences to Secure and Support U.S. – Based Drug Supply and Manufacturing Drug shortages have long plagued U.S. healthcare providers; COVID-19 has compounded sourcing challenges New initiative will manufacture pharmaceutical products in North Carolina, primarily using APIs from the U.S. and Europe Media Contact:Premier – Noah Zachary212.901.1251Public_Relations@premierinc.com CHARLOTTE, N.C., September 8, 2021 ─ Premier Inc. (NASDAQ: PINC), a leading technology-driven healthcare improvement company, and 11 leading health systems acquired a minority stake in Exela Holdings, Inc., the holding company of Exela® Pharma Sciences, LLC, to secure vital supply of
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EXELA’s Position on Use of Our Products in Lethal Injections for Capital Punishment Exela Pharma Sciences believes that providing medicines to alleviate human pain and suffering is one of the noblest undertakings. Making medicines affordable and expediting their availability to the needy is a worthy goal. That is Exela®’s focus and Mission. Exela opposes any use of our products that does not meet our Mission Statement, including the use of Potassium Acetate for lethal injection in capital punishment cases. We have taken actions to ensure our products are only available to those health care providers that use the products for
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Lenoir, NC November 2, 2020 – Exela is pleased to announce that it has divested its ownership of the NDA 212535, covering L-Cysteine Hydrochloride Injection. This NDA was acquired from Avadel Legacy Pharmaceuticals as part of a four products transaction which closed on July 1, 2020. The divestiture includes a license that allows the new owner to enter the market well before the expiry of Exela’s several patents, after obtaining any necessary approvals. “We are pleased to have completed this transaction quickly and efficiently with a competent and reputable injectable products manufacturer/marketer that will commercialize the L-Cysteine Injection product,” stated Dr.
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Lenoir, NC September 11, 2019 – Exela Pharma Sciences is pleased to announce the launch of Sodium Bicarbonate Injection, USP. Exela received approval of its ANDA for Sodium Bicarbonate Injection in May for four separate presentations. The first presentation to launch will be the 8.4% Sodium Bicarbonate Injection, 50mEq/50mL (1mEq/mL) vials. This product has been on the FDA Drug Shortage list consistently and we are excited to be only the second FDA Approved Sodium Bicarbonate Injection on the US market. Exela will introduce shortly three additional presentations: an 8.4%, 10mEq/10mL (1mEq/mL) vial; a 7.5%, 44.6mEq/50mL (0.9mEq/mL) vial; and a 4.2%,
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Lenoir, NC May 31, 2019 – Exela Pharma Sciences is pleased to announce the approval and immediate launch of ELCYS™ (cysteine hydrochloride injection), USP, the only FDA Approved cysteine hydrochloride injection on the market in the United States. ELCYS™ was approved under priority review as a New Drug Application (NDA). It is not an Abbreviated New Drug Application (ANDA) product. The NDA is the result of significant research and development aimed at lowering the Aluminum content in the drug product. ELCYS™ is labeled to contain no more than 120 parts per billion (mcg/L) of Aluminum. ELCYS™ is indicated for use
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April 13, 2018 | Chicago, Illinois On Friday, April 13, 2018, Phanesh Koneru, PhD, LLM, President and CEO of Exela Pharma Sciences interviewed the Honorable George W. Bush, 43rd President of the United States of America at the 9th Annual Becker’s Hospital Review conference in front of 4,000 attendees. The conference is attended by the nation’s leading healthcare CEOs, CFOs and hospital personnel responsible for decision making in America’s hospital networks. President Bush was the Keynote Speaker at Friday’s meeting. During the one hour of highly entertaining and informative interview, Dr. Koneru explored many aspects of the Bush Presidency, including
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Lenoir, NC February 9, 2018 – Exela Pharma Sciences, LLC (“Exela”) today announced that it received FDA approval for NIPRIDE® RTU (sodium nitroprusside) in 0.9% sodium chloride injection, 10mg/50mL (200 mcg/mL) as a supplement to the currently marketed NIPRIDE® RTU 50mg/100mL. NIPRIDE® RTU (sodium nitroprusside) is indicated for the immediate reduction of blood pressure of adult and pediatric patients. NIPRIDE® RTU is also indicated for producing controlled hypotension to reduce bleeding during surgery. NIPRIDE® RTU is also indicated for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean
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