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SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Swiss peptide and peptide intermediates R&D site with SPPS, LPPS, hybrid synthesis, kilo lab scale up, purification and analytics.
서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
지역: 유럽
카테고리 / 제품: 화장품, 화학합성, 서비스, 입자공학
배치 크기: Small
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Small scale GMP peptide and organic synthesis lab for clinical, niche and high value projects requiring flexible cGMP production.
서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
지역: 유럽
카테고리 / 제품: 화학합성, 입자공학
배치 크기: Small
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
파일럿 단계부터 초기 상용 규모까지 LPPS, SPPS 및 하이브리드 펩타이드 제조를 위한 스위스 cGMP 생산 현장입니다.
서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
지역: 유럽
배치 크기: Large, Medium
카테고리 / 제품: 화학합성, 입자공학
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
펩타이드 중간체, 유기 합성, LPPS 운영 및 대규모 생산을 위한 대규모 비 GMP 제조 현장입니다.
서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
지역: APAC
배치 크기: Large, Small, Medium
카테고리 / 제품: 화장품, 화학합성, 서비스, 입자공학
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
SPPS, 정제, 동결 건조, 분석 및 입자 엔지니어링 지원을 갖춘 펩타이드 및 유기 화학을 위한 R&D 센터입니다.
서비스: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
지역: APAC
카테고리 / 제품: 화학합성, 입자공학
배치 크기: Small
시장: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)
지역: APAC, MENA, 라틴 아메리카, 유럽, 북아메리카
규정 준수: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
배치 크기: Large, Medium
사용: Human, Veterinary
BSL(생물학적 안전 수준): 1
서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
치료 전문 분야(ATC): (J) Antiinfectives for systemic use
규제 물질: Lowest potential for abuse
OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
카테고리 / 제품: FDF/의약품
시장: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
지역: 유럽
규정 준수: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
배치 크기: Large, Small, Medium
사용: Human, Veterinary
치료 전문 분야(ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
규제 물질: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
카테고리 / 제품: FDF/의약품
OEB(직업 노출 밴딩): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
시장: EMA (EU)
지역: 유럽
사용: Human
BSL(생물학적 안전 수준): 1, 2
서비스: Manufacturing services, Packaging
배치 크기: Small, Medium
규정 준수: EMA (EU GMP)
카테고리 / 제품: 생물학, FDF/의약품
BSL(생물학적 안전 수준): 3, 1, 2
시장: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
지역: 유럽
배치 크기: Large, Medium
사용: Human, Veterinary
서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
치료 전문 분야(ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
규제 물질: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
규정 준수: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
카테고리 / 제품: FDF/의약품
규정 준수: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
시장: EMA (EU), FDA (USA)
지역: 유럽
배치 크기: Large, Small, Medium
사용: Human, Veterinary
카테고리 / 제품: 올리고뉴클레오티드
서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
OEB(직업 노출 밴딩): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
시장: EMA (EU), FDA (USA), MHRA (UK)
지역: 유럽
규정 준수: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
배치 크기: Large, Small, Medium
사용: Human
BSL(생물학적 안전 수준): 1, 2
서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
카테고리 / 제품: 생물학
시장: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)
지역: APAC
배치 크기: Large, Small, Medium
사용: Human, Veterinary
BSL(생물학적 안전 수준): 1, 2
카테고리 / 제품: 화학합성
서비스: Development services, Manufacturing services
치료 전문 분야(ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system
규제 물질: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
규정 준수: World Health Organization (GMP / HACCP)