ended4월 3일· 1 sources
경보제약, 아산공장 FDA 실사 통과…미국 진출 기반 마련 '한걸음'
Why it matters
Kyungbo Pharmaceutical's FDA inspection clearance validates their manufacturing capabilities for existing pharmaceutical APIs and emerging antibody-drug conjugate (ADC) production, positioning them for US market entry. However, regulatory approval is only the foundation—the critical test will be securing actual US supply contracts, as their significant investments have already pressured profitability without yet generating corresponding revenue growth.
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FDAADC CDMOKyungbo PharmaceuticalAPIGMP