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FDA warning letter
Manufacturing
Indian API maker Cdymax hit with warning letter tied to testing
The letter comes in response to an earlier Form 483 the FDA issued after inspecting Cdymax's facility from April 21-25.
Joseph Keenan
Nov 20, 2025 9:27am
Nephron dinged again by FDA for ongoing manufacturing issues
Oct 23, 2025 8:25am
Celltrion buy, Rexulti CRL, Glenmark-Hengrui—Fierce Pharma Asia
Sep 26, 2025 10:00am
J&J subsidiary slapped with FDA warning letter
Sep 23, 2025 2:22pm
Sun plant placed on FDA import alert over contamination issues
Sep 11, 2025 9:25am
Hikal slammed with warning letter after contamination reports
Sep 11, 2025 8:07am
