Subsidiary of Hunan Warrant Pharmaceutical (688799.SH) passed FDA onsite inspection at Chiral Drug Company
Warner Pharmaceutical Factory (688799.SH) announced that its wholly-owned subsidiary, Hunan Warner Dachem Pharmaceutical 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, 2025 to November 14, 2025. Recently, the company received an Establishment Inspection Report (EIR) from the FDA forwarded by the Chiral Drug Company, indicating that the FDA has confirmed the completion of the inspection and that the Chiral Drug Company has passed the on-site inspection.
Hunan Warrant Pharmaceutical (688799.SH) announced that its wholly-owned subsidiary, Hunan Wanna Dawa Factory Chiral Drug Co., Ltd. (hereinafter referred to as "Chiral Drug Company"), underwent a Pre-Approval Inspection (PAI) from the U.S. Food and Drug Administration (FDA) from November 10th to November 14th, 2025. Recently, the company received the Establishment Inspection Report (EIR) issued by the U.S. FDA forwarded by Chiral Drug Company, indicating that the FDA has confirmed the completion of the inspection and that Chiral Drug Company passed the on-site inspection.
The successful FDA on-site inspection of Chiral Drug Company indicates that its pantoprazole sodium active pharmaceutical ingredient production line complies with the requirements of the U.S. FDA in terms of production management quality system and compliance operation. This will have a positive impact on the company's future operational performance and enhance its competitiveness in the international market, helping the company achieve sustainable and healthy development.
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