PMDA 및 MHLW 일본 GMP CDMO 회사|
일본 GMP 규정 준수 및 제조 서비스

PMDA 및 MHLW GMP 표준을 준수하는 신뢰할 수 있는 일본 CDMO

적용된 필터:PMDA/MHLW (Japan GMP)×모두 지우기

전시 62 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

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

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

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

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 | 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

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 | 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

노르웨이

Adragos Pharma | Halden

Adragos Pharma

당사는 BFS(Blow-Fill-Seal) 기술 및 기타 제형을 사용하여 IV 백, 플라스틱 앰플 및 바이알 제조를 전문으로 합니다.

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

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

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

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

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

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism

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

튀르키예

GENSENTA ILAC SANAYI AS

GENSENTA

CMO, CDMO, FDF 제조업체

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities, SFDA (Saudi Arabia), TGA (Australia)

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

Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), SFDA (Saudi Food & Drug Authority)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, 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, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

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: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

네트워크의 더 많은 시설

연락처 및 위치가 포함된 전체 카탈로그를 잠금 해제하려면 등록하세요.

+28개 이상의 시설

무료 계정 만들기

일본의 의약품의료기기청(PMDA)과 후생노동성(MHLW)은 의약품 개발, 제조, 품질 보증에 대해 세계에서 가장 엄격한 표준 중 일부를 설정했습니다. PMDA 및 MHLW 일본 GMP CDMO 회사와 제휴하면 귀사의 의약품이 일본 규제 기대치와 국제적으로 인정되는 품질 시스템을 완벽하게 준수하는 시설에서 개발 및 제조될 수 있습니다.

귀하가 일본 국내 스폰서이거나 일본 시장과의 규제 조정을 원하는 국제 기업인지 여부에 관계없이 PMDA 및 MHLW GMP를 준수하는 일본 CDMO는 성공에 필요한 기술 역량, 규제 지식 및 제조 우수성을 제공합니다.

PMDA 및 MHLW 일본 GMP CDMO 회사를 선택하는 이유는 무엇입니까?

일본 규제 표준은 품질과 환자 안전에 대한 기준을 나타냅니다. 주요 제약 및 생명공학 기업이 PMDA 및 MHLW 일본 GMP CDMO와 협력하기로 선택한 이유는 다음과 같습니다.

엄격한 GMP 규정 준수: 일본 CDMO는 PMDA 및 MHLW가 관리하는 엄격하게 시행되는 GMP 규정에 따라 운영되어 제품 품질과 안전을 보장합니다.
글로벌 규제 조정: 많은 일본 CDMO는 PMDA/GMP를 EMA 및 FDA 기대치에 맞춰 국제 시장 접근을 촉진한 경험이 있습니다.
기술적 전문성: 일본의 CDMO는 소분자, 복잡한 API, 멸균 제조 및 제제 개발 전반에 걸쳐 고급 기능을 제공합니다.
품질 문화: 정확성, 문서화 및 지속적인 개선에 대한 뿌리 깊은 강조는 재현성과 규제 준비성을 향상시킵니다.
강력한 공급망: 일본의 강력한 제조 생태계는 탄력적인 공급과 안정적인 상업 생산을 지원합니다.

일본 PMDA 및 MHLW CDMO가 제공하는 주요 서비스

PMDA 및 MHLW 규정을 준수하는

일본의 CDMO 회사는 일반적으로 다음을 제공합니다.

GMP 자문 및 규제 지원: PMDA 제출 전략, 감사 지원, CMC 문서화 및 제출 준비.
약물 개발 및 제제: 사전 제제화, 분석 개발 및 제제 설계
임상 제조: PMDA 지침에 따라 1~3상 임상 실험을 위한 재료의 GMP 생산
상업 규모 제조: 일본 및 글로벌 시장을 위한 본격적인 API 및 의약품 생산.
멸균 및 무균 제조: 주사제 및 기타 멸균 제형(충진-완제품 포함)
품질 보증 및 규정 준수: 체계적인 모니터링, 일괄 문서화, 규제 검사 준비

PMDA 및 MHLW 일본 GMP CDMO 기업과의 파트너십 장점

PMDA 및 MHLW GMP 규정을 준수하는 일본 CDMO와 협력하면 다음과 같은 다양한 전략 및 운영상의 이점을 얻을 수 있습니다.

규제 신뢰도: 일본 표준을 완벽하게 준수하면 검사 위험이 줄어들고 제품 수명 주기 유지 관리가 지원됩니다.
향상된 품질 시스템: 일본의 엄격한 품질 문화는 세심한 문서화, 추적성 및 프로세스 제어를 보장합니다.
글로벌 수용: PMDA를 준수하는 많은 시설은 국제 규제 프레임워크(EMA, FDA)에도 부합하여 다중 지역 제출을 지원합니다.
기술적 리더십: 제형 및 GMP 제조 분야에서 최첨단 기술과 과학적 전문 지식을 활용합니다.
전략적 시장 접근: 일본 GMP 규정 준수는 아시아 태평양 및 기타 지역에서 승인이나 파트너십을 모색할 때 상당한 이점을 제공합니다.