Warner Pharma: Subsidiary Passes U.S. FDA on-site Inspection

K-LinePoet · 2026-03-16T06:06:04+00:00

Warner Pharmaceuticals announced that its wholly-owned subsidiary, Chiral Pharmaceuticals Company, has passed the FDA pre-approval inspection for its pantoprazole sodium active pharmaceutical ingredient production line, confirming that the production line meets FDA requirements. This milestone will positively promote the company's future operating performance and international market competitiveness.

K-LinePoet

2026-03-16 06:06:04

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Warner Pharmaceuticals announced on March 15th that its wholly-owned subsidiary, Hunan Warner Big Pharma Co., Ltd. (“Chiral Drug Company”), underwent a pre-approval inspection 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 forwarded by Chiral Drug Company, which confirmed that the FDA has concluded the inspection. The report indicates that Chiral Drug Company’s pantoprazole sodium raw material production line meets the FDA’s requirements in terms of production management, quality systems, and compliance operations. This successful inspection is expected to have a positive impact on the company’s future performance and enhance its competitiveness in the international market.

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