Warner Pharma (688799.SH) subsidiary chiral drug company passes FDA on-site inspection

LootboxPhobia · 2026-03-15T16:05:26+00:00

Warner Pharma's wholly-owned subsidiary Chiral Pharmaceutical Company has passed the U.S. FDA's pre-approval inspection, confirming that its pantoprazole sodium active pharmaceutical ingredient production line complies with FDA requirements. This is expected to have a positive impact on the company's performance and international market competitiveness.

LootboxPhobia

2026-03-15 16:05:26

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Tongtong Finance APP News: Warner Pharmaceuticals (688799.SH) announced that its wholly-owned subsidiary, Hunan Warner Big Pharma Co., Ltd. (hereinafter referred to as “Chiral Drug Company”), underwent a Pre-Approval Inspection (PAI) by the U.S. Food and Drug Administration (FDA) from November 10 to November 14, 2025. Recently, the company received the on-site inspection report (EIR) issued by the U.S. FDA, forwarded by Chiral Drug Company. The report indicates that the FDA has confirmed the inspection has concluded and that Chiral Drug Company has passed the on-site inspection.

Passing this FDA on-site inspection demonstrates that Chiral Drug Company’s pantoprazole sodium raw material production line meets the FDA’s requirements in production management, quality systems, and compliance operations. This will have a positive impact on the company’s future performance and enhance its international market competitiveness, supporting the company’s sustainable and healthy development.

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