GLENDALE HEIGHTS, Ill.--(BUSINESS WIRE)--Medefil, Inc., a domestic manufacturer of injectable products, has announced availability of its FDA-approved ANDA products, Atropine Sulfate Injection, USP, 1 mg per 10 mL (0.1 mg/mL), and 10% Calcium Chloride Injection, USP, 1000 mg per 10 mL (100 mg/mL). Both are offered in a single-dose prefilled syringe. These products are currently listed on the FDA drug shortage list and are available immediately for purchase from Medefil through national wholesalers.
Atropine Sulfate Injection, USP, is used for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.
10% Calcium Chloride Injection, USP is used for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
“Medefil is proud to supply two prefilled syringe products that have been approved by the FDA in a ready-to-administer format, critical for emergency situations,” said Pradeep Aggarwal, CEO & President of Medefil, Inc. “We look forward to growing our injectables portfolio while maintaining our reputation as a consistent and reliable supplier of US developed and manufactured products.”
For complete prescribing information and risks, please see the following link for Atropine Sulfate Injection, USP, and the following link for 10% Calcium Chloride Injection, USP.
About Medefil, Inc.
Medefil is a fully integrated specialty pharmaceutical company that develops, manufactures, and markets flush syringes and injectable drug products. The Company manufactures all products at its fully automated state-of-the-art facility in Glendale Heights, Illinois. Developing and manufacturing products at the highest quality levels with a reliable supply while ensuring safety for patients and ease-of use for providers is our key mission. For more information about Medefil, Inc. and our products, please visit https://www.medefilinc.com