The tentative approval by the US Food and Drug Administration (USFDA) was for the abbreviated new drug application (ANDA) of Amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, Granules India Ltd said in a regulatory filing.
The company had previously received a tentative approval on December 22, 2025 for amphetamine extended release orally disintegrating tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, also used for the treatment of ADHD.
Granules India Share Price Target 2026
Emkay has maintained a Buy call on the pharma stock with a target price of Rs 900.
We note improvements on three major fronts- adequate measures to prevent data breach; digitization initiatives on track with the full implementation of a Manufacturing Execution System expected by the end of CY26; structural as well as process-level changes in air handling units to limit the scope for any form of cross contamination and engagement with three different consultants to address potential gaps across cleaning, validation, cross contamination and documentation, the brokerage said in its note.
