GRAM Congratulates Eton Pharmaceuticals on FDA Approval of Cysteine Hydrochloride Injection
Michigan-based CDMO supports the manufacture of the treatment
April 13, 2022 – Grand River Aseptic Manufacturing (“GRAM”), a leading parenteral contract development and manufacturing organization (CDMO), is thrilled to congratulate Eton Pharmaceuticals, Inc, on their recent U.S. Food and Drug Administration (FDA) approval for its cysteine hydrochloride abbreviated new drug application (ANDA). Eton was granted 180 days of generic exclusivity because of being the first ANDA submitted against the referenced product.
Eton Pharmaceuticals, Inc. focuses on developing and commercializing high-potential therapies for the treatment of patients with rare diseases. Cysteine is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants. The FDA approval of cysteine hydrochloride enables the injectable product to be provided at a lower cost to newborn infants that need cysteine.
“Eton’s commitment to develop a lower cost product that helps newborn infants is especially notable,” said GRAM President and CEO Tom Ross. “GRAM looks forward to supporting the manufacture of cysteine hydrochloride injection for commercial use and we congratulate Eton on this new ANDA approval.”
GRAM is outfitted with technology, experience, systems, and processes that take injectable drug products from clinical trials to commercialization. Eton’s ANDA approval is another example of GRAM’s clinic to commercialization approach and the latest of several FDA approvals that GRAM has supported. Innovative equipment and modern facilities at GRAM support pharmaceutical development and manufacturing in Grand Rapids, MI.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. (“GRAM”), a leading parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules and vaccines, GRAM’s advanced technology and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.