전시 219 시설
스위스
SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Swiss peptide and peptide intermediates R&D site with SPPS, LPPS, hybrid synthesis, kilo lab scale up, purification and analytics.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
Batch Size: Small
스위스
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Small scale GMP peptide and organic synthesis lab for clinical, niche and high value projects requiring flexible cGMP production.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
스위스
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
파일럿 단계부터 초기 상용 규모까지 LPPS, SPPS 및 하이브리드 펩타이드 제조를 위한 스위스 cGMP 생산 현장입니다.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Medium
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
인도
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
펩타이드 중간체, 유기 합성, LPPS 운영 및 대규모 생산을 위한 대규모 비 GMP 제조 현장입니다.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: APAC
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
인도
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
SPPS, 정제, 동결 건조, 분석 및 입자 엔지니어링 지원을 갖춘 펩타이드 및 유기 화학을 위한 R&D 센터입니다.
Services: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
Region: APAC
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
BSL (Biological Safety Level): 3, 1, 2
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
Region: Europe
Batch Size: Large, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Compliance: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Markets: EMA (EU), FDA (USA), MHRA (UK)
Region: Europe
Compliance: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Category / Product: BIOLOGICS
Region: APAC
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
Category / Product: BIOLOGICS
Markets: 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), MFDS (South Korea), CDSCO (India), TGA (Australia)
Region: Europe
Compliance: ISO
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services
Controlled Substances: Lowest potential for abuse
Batch Size: Small, Medium
Category / Product: BIOLOGICS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: 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), 나머지 세계
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS
헝가리
ALPHAVET Zrt.- Bábolna Manufacturing Plant
Alphavet Zrt.
이 공장은 EU GMP 인증을 받았으며 18개 EU 회원국과 EU 이외의 7개 유럽 국가를 위한 동물용 의약품을 생산합니다.
Markets: EMA (EU)
Region: Europe
Compliance: ISO, EMA (EU GMP)
Batch Size: Large, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Veterinary
Services: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
Region: Europe
Compliance: ISO, UAE Ministry of Health & Prevention, EMA (EU GMP)
Use: Human
Services: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
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