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Pharmaron API Commercial Synthesis Shaoxing (China)
중국

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

상업용 API 소분자/펩타이드 합성.

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: NMPA (China), FDA (USA)

지역: APAC

규정 준수: FDA (cGMP), ISO, NMPA (China GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

카테고리 / 제품: 화학합성

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

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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), MHRA (UK), MFDS (South Korea), TGA (Australia)

지역: 유럽

규정 준수: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

카테고리 / 제품: 화학합성

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)

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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)

규정 준수: FDA (cGMP), ISO, ECOVADIS

배치 크기: Large, Small, Medium

사용: Human, Veterinary

카테고리 / 제품: 화학합성

서비스: Development services, Manufacturing 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)

지역: 북아메리카

HIPRA BIOTECH SERVICES | Amer
스페인

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

세포주 개발부터 상업 제조까지 엔드투엔드 내부 역량.

시장: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

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

지역: 유럽

규정 준수: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1, 2

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: 생물학, FDF/의약품

BAG Health Care
독일

BAG Health Care

BAG Health Care GmbH

중소 규모 배치의 바이알을 위한 비경구 F&F 제공업체입니다.

시장: EMA (EU), MHRA (UK), TGA (Australia)

지역: 유럽

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1

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

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

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

카테고리 / 제품: FDF/의약품

Lifecore Injectables CDMO
미국

Lifecore Injectables CDMO

Lifecore Biomedical

임상 및 상업용 무균 주사제를 제조하는 CDMO입니다.

BSL(생물학적 안전 수준): 3, 1, 2

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

규정 준수: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

규제 물질: Lowest potential for abuse

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)

지역: 북아메리카

카테고리 / 제품: FDF/의약품

53Biologics Production Plant
스페인

53Biologics Production Plant

53Biologics

53Biologics는 DNA에서 단백질에 이르기까지 생물학적 제제 생산을 해독하는 데 특화된 스페인 CDMO입니다.

시장: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)

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

지역: 유럽

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

배치 크기: Large, Small, Medium

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1, 2

카테고리 / 제품: 생물학

BDI biotech Production Plant
스페인

BDI biotech Production Plant

BDI biotech

우리는 균주 및 바이오프로세스 개발, 규모 확대 및 배치 생산을 전문으로 하는 R&D 부서로 일하고 있습니다.

시장: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)

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

지역: 유럽

규정 준수: ISO

BSL(생물학적 안전 수준): 1

배치 크기: Small, Medium

카테고리 / 제품: 생물학

Laboratorios Grifols | Murcia Plant
스페인

Laboratorios Grifols | Murcia Plant

Grifols International

유연한 백에 담긴 멸균 제조 솔루션(소분자).

시장: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

서비스: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance 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, (J) Antiinfectives for systemic use, (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

EVER Pharma Jena GmbH
독일

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

저분자 주사제 개발 및 생산을 위한 전문 CDMO입니다.

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, 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), 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: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

배치 크기: Large, Small, Medium

사용: Human

BSL(생물학적 안전 수준): 1, 2

치료 전문 분야(ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

카테고리 / 제품: FDF/의약품

ALPHAVET Zrt.- Bábolna Manufacturing Plant
헝가리

ALPHAVET Zrt.- Bábolna Manufacturing Plant

Alphavet Zrt.

이 공장은 EU GMP 인증을 받았으며 18개 EU 회원국과 EU 이외의 7개 유럽 국가를 위한 동물용 의약품을 생산합니다.

시장: EMA (EU)

지역: 유럽

규정 준수: ISO, EMA (EU GMP)

배치 크기: Large, Medium

카테고리 / 제품: 영양식품, FDF/의약품

사용: Veterinary

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

Avara Pharmaceutical Services | Arecibo Site
미국

Avara Pharmaceutical Services | Arecibo Site

AVARA

규제 물질(DEA II V)에 대한 강력한 전문 지식을 갖춘 상업용 규모의 경구용 고형제(OSD) 제조 시설.

규제 물질: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

규정 준수: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

시장: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

배치 크기: Large, Medium

사용: Human

카테고리 / 제품: 화학합성, 서비스, FDF/의약품, 입자공학

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

치료 전문 분야(ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

지역: 북아메리카

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)

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