이러한 시설은 기본 기준과 일치하지만 모든 선택적 필터와 일치하지는 않습니다.

Bilthoven Biologicals BV
원료의약품 및 완제의약품에 대한 다중 제품 GMP 시설.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU), MHRA (UK)

Green Phoenix Labs GmbH
독일에서 허가된 ATMP 사이트. 세포 및 조직 치료를 위한 GMP 제조 및 QP 배치 출시.
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (S) Sensory organs, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU)
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), FDA (cGMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU), MHRA (UK)
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP), ISO
Use: Human
Region: APAC
Category / Product: BIOLOGICS
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP), FDA (cGMP)
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU)
BSL (Biological Safety Level): 1, 2
MAI network supplier
우리는 귀하의 의약품을 실험실 규모에서 초기 임상 단계 및 그 이상까지 다룰 수 있습니다.
등록 후 이용 가능 위치
MAI network supplier
바이오 의약품, 바이러스 벡터 및 백신의 개발 및 제조 경험을 갖춘 신뢰할 수 있는 CDMO 파트너입니다.
등록 후 이용 가능 위치
MAI network supplier
mRNA 및 LNP 제조 및 충전 및 마감.
등록 후 이용 가능 위치
MAI network supplier
초기 단계 멸균 충진 마감
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MAI network supplier
비멸균 임상 시설(경구 고형 용량)
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MAI network supplier
경구용 고형제(OSD), 비강제, 흡입제, 멸균 건조 분말 및 액상 의약품의 개발 및 제조.
등록 후 이용 가능 위치
MAI network supplier
고급 무균 및 비무균 의약품 제조, 제제 개발 및 분석 테스트를 위한 신뢰할 수 있는 GMP CDMO입니다.
등록 후 이용 가능 위치
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