Zhejiang Davi Pharmaceutical Co., Ltd., established in 2004, is an exclusively foreign-owned high-tech manufacturer of active pharmaceutical ingredients and intermediates located in Huzhou City, Zhejiang, China. With a total investment of $8M USD and 35,000 m2 floor space, they operate FDA and COS-required GMP workshops. They specialize in folate-related APIs: Methotrexate, Methotrexate Sodium, Calcium Folinate (Leucovorin Calcium), Calcium Levofolinate, and L-5-Methyltetrahydrofolate Calcium. The company is FDA-registered with 3 FEI numbers, has 8 FDA inspections (2 NAI, 6 VAI, 0 OAI), 1 Class II recall, 4 FDA-approved products (tablet, extended-release tablet), and participates at CPHI events globally. They undertake OEM orders for intermediates. Classified as API manufacturer rather than CDMO because they primarily manufacture their own specialty APIs; contract services appear limited to OEM intermediate orders.
folate/antifolate API manufacturing (methotrexate, leucovorin, calcium folinate), GMP intermediates, CEP/DMF filings
1 site worldwide
Involvement in 1 clinical trial
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