주사제 CDMO 기업|
주사제 계약 제조 서비스

주사제 계약 제조 및 개발을 위한 신뢰할 수 있는 주사제 CDMO 파트너

적용된 필터:주사제×FDF / DRUG PRODUCTS×모두 지우기

전시 61 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

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

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

네덜란드

Bilthoven Biologicals Drug Substance and Drug Product Facilities

Bilthoven Biologicals BV

원료의약품 및 완제의약품에 대한 다중 제품 GMP 시설.

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2

Markets: EMA (EU), MHRA (UK)

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

Compliance: EMA (EU GMP)

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

Region: Europe

스페인

Laboratorios Grifols | Barcelona Plant

Grifols International

유연한 백과 바이알에 담긴 멸균 제조 솔루션(소분자).

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human, Veterinary

Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), ANMAT (Argentina), TGA (Australia)

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

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), INVIMA, ECOVADIS, TGA (Australia GMP), ISP (Chile BPM), 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)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

Therapeutic Areas of Expertise (ATC): (N) Nervous system, (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), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS

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

스위스

Adragos Pharma | Jura

Adragos Pharma

당사는 충진 및 마무리 과정을 거쳐 동결건조 또는 액상 멸균 (바이오)의약품의 무균 제조를 전문으로 합니다.

우리 시설을 찾아보세요

Use: Human

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), MHRA (UK), MFDS (South Korea)

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

Compliance: FDA (cGMP), EMA (EU GMP)

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)

Controlled Substances: High potential for abuse & no medical use

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

프랑스

Adragos Pharma | Livron

Adragos Pharma

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

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human

Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), MFDS (South Korea), TGA (Australia)

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

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

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

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

스페인

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

베타락탐 항생제(FDF) 개발 및 최첨단 시설 제조.

우리 시설을 찾아보세요

Batch Size: Large, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Compliance: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), World Health Organization (GMP / HACCP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP)

Markets: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, SFDA (Saudi Arabia), INVIMA (Colombia), TGA (Australia)

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

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use

Controlled Substances: Lowest potential for abuse

Category / Product: FDF / DRUG PRODUCTS

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

Region: Europe

네트워크의 더 많은 시설

연락처 및 위치가 포함된 전체 카탈로그를 잠금 해제하려면 등록하세요.

+29개 이상의 시설

무료 계정 만들기

주사제는 현대 의학의 중요한 구성 요소로 모든 단계에서 정밀성, 무균성 및 엄격한 규정 준수가 필요합니다. 주사제 계약 개발 및 제조 조직(CDMO)은 제약 회사가 이러한 제품을 빠르고 효율적으로 시장에 출시하도록 돕는 데 중요한 역할을 합니다. 개발부터 대규모 생산까지 주사제 CDMO는 각 프로젝트의 고유한 요구 사항을 충족하는 맞춤형 솔루션을 제공합니다.

주사제 계약제조업체 선택 방법

올바른 주사제 계약 제조업체를 선택하는 것은 제품 안전성, 효능 및 규정 준수를 보장하는 데 필수적입니다. 멸균 제조에 대한 전문 지식과 유사한 제품에 대한 실적을 평가하는 것부터 시작하십시오. 시장 전반에 걸쳐 완전한 규정 준수를 보장하려면 CDMO가 EMA, FDA, WHO와 같은 글로벌 규제 기관의 인증을 보유하고 있는지 확인하세요.

제조업체의 시설을 방문하여 기술, 청결도, 무균 처리 능력을 평가하는 것도 중요합니다. 마지막으로 소규모 임상 시험 배치와 대규모 상업 규모 생산을 모두 원활하게 처리할 수 있는지 여부 등 확장성을 고려하세요.

주사제 CDMO가 제공하는 주요 서비스

제형 개발: 수성, 유성 및 현탁액을 포함한 다양한 주사용 형식에 대한 안정적이고 효과적인 제제 개발에 대한 전문 지식입니다.
무균 제조: 동결건조 및 고도차 봉쇄 기술을 포함하여 제품 안전성과 효능을 보장하는 고급 멸균 제조 역량입니다.
규제 지원: EMA, FDA, WHO와 같은 글로벌 규제 기관에 대한 서류 제출 및 규정 준수를 지원하여 원활한 시장 진입을 보장합니다.
포장 솔루션: 주사제 제품을 위한 맞춤형 1차 및 2차 포장으로 적절한 무균성, 안정성 및 규제 표준 준수를 보장합니다.
분석 테스트: 생산 과정 전반에 걸쳐 주사제의 안전성, 안정성 및 일관성을 보장하기 위한 종합적인 테스트입니다.

주사제 제조사와의 제휴의 장점

규정 준수: 주사제 CDMO는 글로벌 규제 표준에 정통하여 제품이 최고의 안전성 및 효능 벤치마크를 충족하도록 보장합니다.
최첨단 시설: 무균 및 고도 격리 제조를 포함한 첨단 기술을 갖춘 주사제 제조업체는 우수한 품질과 정밀도를 제공합니다.
유연성 및 확장성: 소규모 임상 배치이든 본격적인 상업 생산이든 주사제 CDMO는 변화하는 프로젝트 요구 사항을 충족할 수 있는 적응형 솔루션을 제공합니다.
시장 출시 시간 효율성: 주사제 제조업체는 간소화된 프로세스와 규제 전문성을 활용하여 생산 일정을 단축하고 시장 진입을 가속화할 수 있습니다.
비용 효율성: 주사제 CDMO는 품질 저하 없이 비용 효율적인 생산을 제공하므로 제약 파트너십을 위한 현명한 선택입니다.