FDA cGMP CDMO 기업|
FDA 준수 제조 서비스

FDA 준수 제조 및 개발을 위한 신뢰할 수 있는 파트너

적용된 필터:FDA (cGMP)×모두 지우기

전시 119 시설

정렬 기준:

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.

우리 시설을 찾아보세요

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

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

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

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: APAC

이탈리아

Aenova Group - Location Latina, Italy

Aenova

Competence Center 동물 보건 제품 및 멸균 기술.

우리 시설을 찾아보세요

Markets: ANVISA (Brazil), FDA (USA), EMA (EU), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2

Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)

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

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

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.

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

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

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

Region: APAC

슬로베니아

JAFRAL

R&D, 비GMP 및 GMP 제조, QC 테스트, 고급 생물학제제에 대한 충진 및 마감 서비스를 제공하는 통합 생명공학 시설입니다.

우리 시설을 찾아보세요

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), TGA (Australia)

Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2

Compliance: ISO, ICH, FDA (cGMP), World Health Organization (GMP / HACCP), EMA (EU GMP), SQF (Safe Quality Food)

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

Controlled Substances: Lowest potential for abuse

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

Region: Europe

그리스

Adragos Pharma | Athens

Adragos Pharma

부가가치 의약품 개발을 전문으로 하며 최근 HPAPI 기능으로 업그레이드되었습니다.

우리 시설을 찾아보세요

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

Batch Size: Large, Small, Medium

Use: Human

Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), NMPA (China GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

인도

HIKAL | Mumbai

Hikal Ltd.

Hikal은 소분자, HPAPI, 공정 개발, 맞춤형 합성 및 상업 제조를 전문으로 하는 선도적인 제약 CDMO입니다.

우리 시설을 찾아보세요

Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia), 나머지 세계

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2, 3, 4

Compliance: ISO, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), ECOVADIS, World Health Organization (GMP / HACCP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), PMDA (Japan), ANVISA (Brazil), Health Canada

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: APAC

스위스

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

크로마토그래피를 포함한 개발 및 중간 규모 cGMP 제조.

우리 시설을 찾아보세요

Use: Human, Veterinary

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

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

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

Batch Size: Small, Medium

Category / Product: SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

프랑스

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

맞춤형 제제 개발 및 액상 및 동결건조 의약품의 GMP 멸균 제조.

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

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

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

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), French Service-Public (CIR), ANMAT (Argentina nueva GMP), Health Canada (Canada GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

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

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

스위스

CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS

개발 및 중간 규모 제조.

우리 시설을 찾아보세요

Use: Human, Veterinary

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

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

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

Batch Size: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: Europe

네덜란드

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

콜레스테롤 및 비타민 D 유사체의 대규모 제조.

우리 시설을 찾아보세요

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Compliance: DIGEMID, BRCGS, ISO, FDA (cGMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, TGA (Australia GMP), ISP (Chile BPM), French Service-Public (CIR), ANMAT (Argentina nueva GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

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

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

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

Batch Size: Small

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: Europe

스위스

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

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

우리 시설을 찾아보세요

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

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

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

Use: Human, Veterinary

Batch Size: Small

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

Category / Product: CHEMICAL-SYNTHETIC

스위스

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

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

우리 시설을 찾아보세요

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

Markets: 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)

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

Use: Human, Veterinary

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

Batch Size: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: PARTICLE ENGINEERING, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

Region: Europe

네트워크의 더 많은 시설

연락처 및 위치가 포함된 전체 카탈로그를 잠금 해제하려면 등록하세요.

+69개 이상의 시설

무료 계정 만들기

미국 시장을 목표로 하는 제약 및 생명공학 기업의 경우 FDA cGMP CDMO 기업은 규정 준수, 제품 품질 및 시장 접근을 보장하는 데 필수적인 파트너입니다. FDA 규정 준수 조건에 따라 제조한다는 것은 문서 및 시설 표준부터 데이터 무결성 및 배치 일관성에 이르기까지 모든 것을 포괄하는 해당 기관의 cGMP(현행 우수제조관리기준)을 충족함을 의미합니다.

풀서비스 FDA 준수 제조를 통해 이러한 CDMO는 개발부터 상업 출시까지 제품을 지원하여 모든 단계가 21 CFR Parts 210/211 및 관련 FDA 지침에 부합하도록 보장합니다.

FDA cGMP CDMO 업체 선택 방법

FDA cGMP CDMO 기업을 선택할 때 중요한 평가 사항은 다음과 같습니다.

입증된 FDA 검사 기록(성공적인 감사, 주요 483 또는 경고 서한 없음)
미국 시장 공급을 위해 설계된 GMP 인증 시설
품질 관리 시스템은 FDA 데이터 무결성 및 위험 관리 지침에 부합합니다.
문서화 시스템: 배치 기록, 편차, CAPA 및 검증 프로토콜
공정 검증 및 세척 검증 전문 기술
IND, NDA, ANDA 및 DMF 제출에 대한 규제 지원
임상 및 상업적 공급 지원 능력

올바른 CDMO는 제품 수명주기의 모든 단계에서 제품 무결성과 감사 준비를 보장합니다.

FDA 준수 제조 파트너가 제공하는 주요 서비스

최상위 FDA 준수 제조 제공업체는 일반적으로 다음을 제공합니다.

제형 개발 및 공정 최적화
경구용 고형제, 액상제, 주사제 및 생물학적 제제에 대한 GMP 제조
분석 방법 개발 및 검증
FDA 검토 조건에 따른 멸균 및 비멸균 충진 마감
일괄 출시, QA/QC 테스트 및 제품 안정성 연구
21 CFR 표준을 충족하는 품질 보증 시스템
CMC 및 규제 서류 지원
감사 지원 및 사전 승인 검사 준비

이러한 서비스는 미국 상업화를 목표로 하거나 미국 기반 임상 시험을 수행하는 회사에 필수적입니다.

FDA cGMP CDMO 기업과 제휴의 장점

경험이 풍부한 FDA cGMP CDMO 회사와 협력하면 다음과 같은 상당한 이점을 얻을 수 있습니다.

사전 검증된 인프라를 통한 미국 시장 준비
검증되고 감사를 통해 입증된 시스템을 통해 규정 준수 위험 감소
강력한 규제 문서를 통해 더 빠른 승인 지원
개발 초기부터 승인 후 공급까지원활한 확장
cGMP 인증 및 FDA 검사 이력을 통한 규제 기관 및 이해관계자의 신뢰

FDA 규정 준수는 선택 사항이 아니며 올바르게 수행하면 경쟁 우위를 확보할 수 있습니다.