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귀하의 약물 개발 및 제조 프로젝트를 위한 고도로 숙련된 파트너를 찾아보세요.

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CZ Vaccines | Large Scale Plant Spain
스페인

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

일회용 상업용 규모 시설

시장: EMA (EU)

서비스: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

지역: 유럽

규정 준수: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

배치 크기: Large, Medium

사용: Human

BSL(생물학적 안전 수준): 1, 2

치료 전문 분야(ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones

카테고리 / 제품: 생물학, FDF/의약품

Cellex Cell Professionals
독일

Cellex Cell Professionals

Cellex Cell Professionals

CGT CDMO 세포 제조 공장 및 출발 물질 수집 센터

시장: EMA (EU), FDA (USA)

서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

지역: 유럽

규정 준수: FDA (cGMP), EMA (EU GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1, 2

카테고리 / 제품: 생물학, 서비스, FDF/의약품

CARBOGEN AMCIS | Vionnaz
스위스

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

크로마토그래피 및 동결건조를 포함한 매우 강력한 API 개발 및 소규모 cGMP 생산.

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

지역: 유럽

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

사용: Human, Veterinary

카테고리 / 제품: 화학합성

서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance 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)

배치 크기: Small

CARBOGEN AMCIS | Veenendaal
네덜란드

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

콜레스테롤 및 비타민 D 유사체의 대규모 제조.

치료 전문 분야(ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

지역: 유럽

규정 준수: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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), SQF (Safe Quality Food), NSF

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1

카테고리 / 제품: 화학합성, 서비스

배치 크기: Small

치료 전문 분야(ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

서비스: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

지역: APAC

배치 크기: Large, Small, Medium

사용: Human

카테고리 / 제품: 올리고뉴클레오티드, 화학합성, 서비스

규정 준수: ANVISA (Brazil B-GMP), NMPA (China GMP)

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)

CARBOGEN AMCIS | Saint-Beauzire
프랑스

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

맞춤형 제제 개발 및 액상 및 동결건조 의약품의 GMP 멸균 제조.

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)

규제 물질: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

지역: 유럽

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), French Service-Public (CIR), 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

서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

치료 전문 분야(ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

카테고리 / 제품: FDF/의약품

CARBOGEN AMCIS | Neuland
스위스

CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS

개발 및 중간 규모 제조.

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

지역: 유럽

규정 준수: FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

사용: Human, Veterinary

카테고리 / 제품: 화학합성, 서비스

서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

배치 크기: Small, Medium

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)

CARBOGEN AMCIS | Manchester, UK
영국

CARBOGEN AMCIS | Manchester, UK

CARBOGEN AMCIS

당사의 화장품 성분 제조 역량, 정밀 화학물질 및 제약 중간체 맞춤형 합성 역량을 알아보세요.

지역: 유럽

규정 준수: ISO, Halal Research Council, ECOVADIS

배치 크기: Large, Small, Medium

카테고리 / 제품: 화학합성, 서비스, 입자공학

서비스: Development services, Manufacturing services, Analytical / QC services

OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Aarau
스위스

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

크로마토그래피를 포함한 개발 및 중간 규모 cGMP 제조.

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

지역: 유럽

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

사용: Human, Veterinary

카테고리 / 제품: 화학합성, 생물학, 서비스, 입자공학

서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

배치 크기: Small, Medium

OEB(직업 노출 밴딩): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Bubendorf
스위스

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

항체 약물 결합체(ADC)를 포함한 고효능 API의 개발 및 cGMP 제조.

시장: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

지역: 유럽

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

사용: Human, Veterinary

카테고리 / 제품: 화학합성, 생물학, 서비스, 입자공학

서비스: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

치료 전문 분야(ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

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)

배치 크기: Small, Medium

Apeloa Pharmaceutical Co., Ltd.
중국

Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd

Apeloa CDMO는 API, 중간체 및 RSM에 대한 세계적 수준의 검색, 개발 및 제조 서비스를 제공합니다.

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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

지역: APAC

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

카테고리 / 제품: 화학합성

서비스: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging

AMSbiopharma
스페인

AMSbiopharma

AMSbiopharma

우리는 의약품 개발의 모든 단계에서 제약, 바이오제약, 화학 산업을 지원하기 위한 분석 서비스를 제공합니다.

규정 준수: ICH, ISO, World Health Organization (GMP / HACCP)

시장: EMA (EU)

지역: 유럽

사용: Human, Veterinary

서비스: Development services, Analytical / QC services

카테고리 / 제품: 서비스

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