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Tonghe Pharmaceutical announced that the company recently received the DMF No Further Comments Letter for Mirabelone API registration approval letter issued by the US Food and Drug Administration, drug main document number 031661. The product received an NFC letter indicating that the FDA has completed the technical review and can meet the ANDA reporting requirements of related formulation customers, which is beneficial for the company to expand its business in the international market.

Zhitongcaijing·08/11/2026 08:41:04
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Tonghe Pharmaceutical announced that the company recently received the DMF No Further Comments Letter for Mirabelone API registration approval letter issued by the US Food and Drug Administration, drug main document number 031661. The product received an NFC letter indicating that the FDA has completed the technical review and can meet the ANDA reporting requirements of related formulation customers, which is beneficial for the company to expand its business in the international market.