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JW중외, 항생제 제네릭 ‘어타페넴’ 완제품 "美 출시" - 바이오스펙테이터

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JW중외, 항생제 제네릭 ‘어타페넴’ 완제품 "美 출시"

입력 2021-06-09 15:44 수정 2021-06-09 22:11

바이오스펙테이터 노신영 기자

"국산 페넴계 항생제 원료 최초 미국 DMF 승인"

JW중외제약은 9일 자체 원료로 제조한 카바페넴계 항생제 제네릭 '어타페넴(Ertapenem)' 완제품이 미국 시장에 출시됐다고 밝혔다. JW중외제약에 따르면 국산 카바페넴계 항생제 원료로 생산된 완제품이 최대시장인 미국에서 판매되는 것은 이번이 처음이다.

JW중외제약은 2017년 지주회사 JW홀딩스와 인도 그랜드파마(Gland Pharma)가 어타페넴 원료 수출계약을 체결한 이후, 미국 식품의약국(FDA)으로부터 시화공장 페넴계 항생제 전용동에 대한 cGMP(의약품 제조 및 품질관리기준) 인증과 어타페넴 원료의 DMF(Drug Master File, 원료의약품등록제도) 승인을 받았다고 설명했다

그랜드파마는 JW중외제약 시화공장에서 제조된 어타페넴 원료를 활용해 완제품을 생산하고 지난 3월 미국 FDA로부터 시판허가를 획득했다. 미국 판매는 닥터레디(Dr. Reddy’s Laboratories)가 담당한다. 어타페넴의 오리지널 약은 미국 머크(MSD)의 '인반즈(INVANZ)'다.

JW그룹의 글로벌사업을 담당하는 JW홀딩스는 앞으로 어타페넴 원료를 그랜드파마에 공급하게 되면서 안정적인 수출 판로를 확보하게 됐다고 설명했다. 또한 현재 그랜드파마와 함께 캐나다를 비롯한 다른 해외시장 진출도 준비하고 있다.

또한 국내 최초로 독자원료 개발에 성공한 최신 카바페넴 계열인 도리페넴의 글로벌 진출을 본격화하는 동시에 중국, 일본 등 40여 개국에 수출하고 있는 이미페넴, 메로페넴 원료·완제의약품 수출도 확대해 나갈 계획이다.

한성권 JW홀딩스 대표는 “카바페넴계 항생제 분야에서의 첫 미국 국산원료 진출로 JW의 기술력을 입증받는 계기가 됐다”며 “앞으로도 글로벌 파트너사와의 협력을 강화해 어타페넴, 도리페넴과 같은 차세대 카바페넴계 시장 진출을 더욱 가속화할 것”이라고 말했다.

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