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세레스에프앤디, 印 제약사와 '타크로리무스' 공급 협약 - 바이오스펙테이터

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세레스에프앤디, 印 제약사와 '타크로리무스' 공급 협약

입력 2019-10-18 21:44 수정 2019-10-18 22:52

바이오스펙테이터 장종원 기자

인도 스트라이드 파마 사이언스와 FDA 승인 완료 이후 8년간 600억 규모 공급

알테오젠 자회사 세레스에프엔디는 최근 인도 제약회사인 스트라이드 파마 사이언스(Strides pharma Science)와 면역억제제 의약품 원료 타크로리무스(Tacrolimus)의 미국시장 공급을 위한 협약을(MOU) 체결했다고 18일 밝혔다.

이번 협약을 통해 알테오젠은 타크로리무스의 미국 식품의약국(FDA) 승인절차를 완료한 이후 8년간 매년 약 80억원, 총 600억원 이상의 원료의약품을 스트라이드에 독점 공급하기로 했다. 또한 공급개시 후 2년 내 연간 약 200억원 규모로 공급 물량을 늘리는 양사의 전략적 및 재정적 제휴도 이번 협약에 포함됐다.

아울러 스트라이드의 FDA 인증에 대한 경험과 노하우를 현재 제천에 신축 중인 세레스의 면역억제제 전용 공장 라인과 품질관리시스템에 적용할 수 있도록 인적, 물적 교류를 실시하기로 합의했다.

이후 세레스의 면역억제제 원료 파이프라인인 실로리무스(Sirolmus) 및 에버로리무스(Everolimus)의 추가적인 미국시장 원료의약품 독점 공급계약에 대해 스트라이드와 우선 협상을 진행을 하는 것에도 합의했다.

스트라이드는 1990년 인도 방갈로르(Bangalore)에 설립된 제약회사로 총 5개의 제약공장을 보유하고, 이중 4개 공장이 FDA 인증을 받았다. 2018년 기준 3조 6000억원의 매출을 기록하고 있다.

스트라이드는 2018년 기준 미국시장에 65개 제품에 대해서 ANDA 허가를 받아서 판매 중이며 2019년까지 100여개 이상으로 ANDA 승인 제품을 늘리려고 허가를 진행하고 있다.

한편 세레스는 작년 6월 알테오젠의 자회사로 설립돼 원료의약품 GMP 설비를 가진 공장을 인수했고 현재 글리코펩타이드 항생제인 반코마이신과 면역억제제인 타크로리무스를 생산하고 있다. 오는 23일 타크로리무스 전용 cGMP공장 준공식을 진행할 예정이다.

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