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Adragos Pharma | Livron
프랑스

Adragos Pharma | Livron

Adragos Pharma

멸균액체 및 좌약 제조. 100개 이상의 분자, 마약류 관리, 분석 및 안정성 서비스를 처리하고 있습니다.

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

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

지역: 유럽

배치 크기: Large, Small, Medium

사용: Human

규정 준수: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

카테고리 / 제품: FDF/의약품

Glatt Pharmaceutical Services GmbH Co. & KG
독일

Glatt Pharmaceutical Services GmbH Co. & KG

Glatt Pharmaceutical Services GmbH Co. & KG

독일 Binzen에 본사를 두고 복잡한 경구용 고형제 분야의 엔드투엔드 서비스를 위한 cGMP 준수 CDMO입니다.

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), FDA (USA)

지역: 유럽

규정 준수: FDA (cGMP), EMA (EU GMP)

배치 크기: Large, Small, Medium

사용: Human, Veterinary

BSL(생물학적 안전 수준): 1

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

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, (V06) Nutrients, (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)

카테고리 / 제품: FDF/의약품

Adare Pharma | US
미국

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO 글로벌 설치는 EE.UU에 있습니다. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación camerci

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), EDE (UAE), TGA (Australia)

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

규정 준수: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China 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, (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)

지역: 북아메리카

카테고리 / 제품: 서비스, FDF/의약품, 입자공학

Adare Pharma | EU
이탈리아

Adare Pharma | EU

Adare Pharma Solutions

경구용 제형에 초점을 맞춘 상업적 제조 전문 지식을 통해 턴키 제품 개발을 제공하는 글로벌 CDMO입니다.

치료 전문 분야(ATC): (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V01) Allergens

시장: TGA (Australia), 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), EDE (UAE)

규정 준수: French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention

배치 크기: Small, Medium, Large

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), 4 / HPAPI (PDE = 10 - 100 µg/day)

카테고리 / 제품: 서비스, FDF/의약품, 입자공학

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

지역: 유럽

사용: Human, Veterinary

Green Phoenix Labs GmbH
독일

Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Cleanroom 용량이 초과된 세포치료제 회사입니다.

치료 전문 분야(ATC): (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system

규제 물질: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

규정 준수: EMA (EU GMP)

카테고리 / 제품: 생물학, 서비스, FDF/의약품

시장: EMA (EU)

서비스: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

지역: 유럽

사용: Human

BSL(생물학적 안전 수준): 1

Seda Pharma Development Services
영국

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services는 통합 의약품 개발 및 임상 약리학을 전문으로 합니다.

치료 전문 분야(ATC): (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (B) Blood and blood forming organs

시장: TGA (Australia), Rest of World, 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)

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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

규정 준수: MHRA (UK GMP), ECOVADIS

카테고리 / 제품: FDF/의약품

지역: 유럽

사용: Human

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

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
중국

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

Seacross Pharmaceutical Co Ltd

R&D 센터 및 제형 공장과 함께 세 개의 핵심 사이트 중 하나인 당사의 API 제조 시설은 통합 공급망에서 중요한 역할을 합니다.

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), 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: APAC

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

배치 크기: Large, Small, Medium

사용: Human

BSL(생물학적 안전 수준): 1, 2, 3, 4

카테고리 / 제품: 화학합성

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, (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, (V04) Diagnostic agents

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), 5 / HPAPI (PDE < 10 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
중국

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

R&D 센터는 API와 최종 제형의 개발을 모두 지원하는 데 근본적인 역할을 합니다.

규정 준수: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, 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)

카테고리 / 제품: FDF/의약품, 화학합성

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

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

BSL(생물학적 안전 수준): 3, 4, 1, 2

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), 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: APAC

배치 크기: Large, Small, Medium

사용: Human

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
중국

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

제제 제조 현장은 복잡하고 가치가 높은 제형의 개발 및 생산에 전념하고 있습니다.

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

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)

BSL(생물학적 안전 수준): 3, 4, 1, 2

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), 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: APAC

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

배치 크기: Large, Small, Medium

사용: Human

카테고리 / 제품: 서비스, FDF/의약품

PHARMALOOP S.L. - a Salvat Company
스페인

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

BFS(Blow-Fill-Seal), 멸균 다회 용량, 비멸균 다회 용량, 봉지, 캡슐 및 정제를 위한 완전히 통합된 CDMO 솔루션입니다.

시장: EMA (EU), FDA (USA)

지역: 유럽

규정 준수: FDA (cGMP), ISO, EMA (EU GMP)

배치 크기: Large, Small, Medium

사용: Human

BSL(생물학적 안전 수준): 1

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

치료 전문 분야(ATC): (S) Sensory organs, (V01) Allergens

카테고리 / 제품: FDF/의약품, 입자공학

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

Ophtapharm, a Sentiss Company
스위스

Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

안과 및 귀 - 용액, 현탁액, 유제, 연고 및 젤 - FDA 승인 시설.

시장: EMA (EU), FDA (USA)

지역: 유럽

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

배치 크기: Large, Small, Medium

사용: Human, Veterinary

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

카테고리 / 제품: FDF/의약품

Cenexi SAS
프랑스

Cenexi SAS

Cenexi

Accueil 사이트 Osny. 2011년에 인수된 Osny 사이트는 고활성 고체 의약품 형태의 개발 및 생산을 전문으로 합니다.

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), ANVISA (Brazil), MHRA (UK), MFDS (South Korea)

지역: 유럽

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

사용: Human

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

치료 전문 분야(ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (G) Genito urinary system and sex hormones

배치 크기: Small, Medium

카테고리 / 제품: FDF/의약품

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