FDA approves manufacturing supplement for Gland's epinephrine ANDA
The FDA cleared a chemistry, manufacturing, and controls update for Gland Pharma's epinephrine injection covering two dosage strengths.
Gland's epinephrine ANDA saw a manufacturing update clear FDA review this week.
- A supplemental application for epinephrine (ANDA219239), classified as a manufacturing (CMC) submission, was approved with a status date of 2026-09-22.1 The product is available as a solution in two strengths, 10MG/10ML and 30MG/30ML, both at 1MG/ML, administered by intramuscular, intravenous, or subcutaneous routes.1
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