PMCTPharmaCountry
    Home

Regulatory Updates

FDA, EMA, TGA and global regulatory developments

#Bionpharma ×

UPDATED
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves DIVALPROEX SODIUM (ANDA078853)
FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.
UPDATED
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Bionpharma’s Nicardipine Hydrochloride Capsules (ANDA217555)
The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.