마약 및 규제 약물 CDMO 회사|
통제된 의약품 제조 및 규정 준수 서비스

마약 및 규제 의약품에 대한 신뢰할 수 있는 파트너

적용된 필터:High potential for abuse & no medical use×High potential for abuse & medical use×모두 지우기

전시 59 시설

정렬 기준:

영국

Arcinova Ltd. – Alnwick, UK

Arcinova - A Quotient Sciences Company

Arcinova는 초기 발견부터 개념 증명 및 그 이상까지 약물 개발을 가속화합니다.

우리 시설을 찾아보세요

Compliance: ICH, FDA (cGMP), MHRA (UK GMP), EMA (EU GMP), MHRA (UK)

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

Markets: Health Canada (Canada), FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK)

Use: Human

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, Narcotic

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)

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

Region: Europe

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

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

독일

Glatt Pharmaceutical Services GmbH Co. & KG

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

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Markets: FDA (USA), EMA (EU)

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

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

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): (B) Blood and blood forming organs, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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

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

독일

Adragos Pharma | Leipzig

Adragos Pharma

비멸균 반고체 및 액상 의약품.

우리 시설을 찾아보세요

Batch Size: Large, Small, Medium

Use: Human, Veterinary

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

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

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, 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), 2 (PDE = 1,000 - 5,000 µg/day)

Compliance: EMA (EU 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

네트워크의 더 많은 시설

연락처 및 위치가 포함된 전체 카탈로그를 잠금 해제하려면 등록하세요.

+35개 이상의 시설

무료 계정 만들기

마약 및 규제 약물의 개발 및 제조에는 탁월한 수준의 규제 준수, 보안 및 기술 전문 지식이 필요합니다. 전문적인 마약 및 규제 물질 CDMO 회사는 GMP 준수 인프라, 허가 시설, 검증된 프로세스를 제공하여 고도로 규제된 API 및 완제품 투여 형태를 안전하게 처리합니다.

오피오이드 진통제 및 CNS 활성 화합물부터 기타 예정된 약물 물질에 이르기까지 경험이 풍부한 통제 약물 CDMO와 협력하여 임상 및 상업 프로그램 전반에 걸쳐 법적 준수, 공급망 무결성, 일관된 의약품 품질을 보장합니다.

마약 및 규제 약물 CDMO 회사를 선택하는 방법

규제, 안전, 평판 위험으로 인해 올바른 규제 물질 CDMO를 선택하는 것이 중요합니다. 고려해야 할 주요 요소는 다음과 같습니다:

라이센스 및 허가: 지정 물질을 제조, 취급, 저장 및 유통할 수 있는 유효한 승인입니다.
규정 준수: GMP, DEA, EMA, FDA 및 현지 마약 당국을 완벽하게 준수합니다.
보안 인프라: 액세스 제어, 감시 시스템, 관리 연속성 제어 및 재고 조정.
격리 능력: 강력하거나 독성이 있거나 남용되기 쉬운 화합물을 위해 설계된 시설.
복용 형태에 대한 경험: 경구용 고형제, 경구용 액제, 주사제, 경피 시스템 및 변형 방출 제품.
감사 준비: 규제 검사 및 고객 감사를 통해 입증된 실적입니다.

통제 물질 CDMO가 제공하는 주요 서비스

주요 마약 CDMO 회사는 일반적으로 다음을 제공합니다.

통제 물질의 API 처리 및 제조
마약성 및 중추신경계 활성 의약품의 제형 개발
GMP 조건에 따른 임상 시험 재료 제조
안전한 보관 및 유통을 갖춘 상업적 규모의 제조
무균 및 비멸균 제품에 대한 통제된 물질 충전 마감
포장 및 라벨링은 의약품 통제 규정을 준수합니다.
품질 관리 및 안정성 테스트
글로벌 시장을 위한 규제 및 라이선스 지원

마약류 및 규제 약물 CDMO 회사와의 파트너십의 이점

특수 규제 약물 CDMO를 사용하면 다음과 같은 주요 전략적 이점을 얻을 수 있습니다.

규제 보증: 라이센스 및 감사를 받는 운영을 통해 규정 준수 위험을 줄입니다.
안전한 공급망: API 수령부터 완제품 유통까지 강력한 제어.
운영 안정성: 재고 관리, 조정 및 보고를 위한 입증된 시스템입니다.
기술적 전문성: 강력한 API 및 남용 방지 공식에 대한 깊은 이해
확장 가능한 용량: 초기 임상 단계부터 상용 출시까지 지원합니다.