
Seacross Pharmaceutical Co Ltd
R&D 센터는 API와 최종 제형의 개발을 모두 지원하는 데 근본적인 역할을 합니다.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 나머지 세계, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Compliance: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
Controlled Substances: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (Biological Safety Level): 3, 4, 1, 2
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Region: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Laboratorios Salvat
BFS(Blow-Fill-Seal), 멸균 다회 용량, 비멸균 다회 용량, 봉지, 캡슐 및 정제를 위한 완전히 통합된 CDMO 솔루션입니다.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Compliance: EMA (EU GMP), FDA (cGMP), ISO
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU)
Therapeutic Areas of Expertise (ATC): (V01) Allergens, (S) Sensory organs
BSL (Biological Safety Level): 1
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
MAI network supplier
생물학적 제제 및 주사제의 무균 제조 및 동결건조를 위한 신뢰할 수 있는 CDMO 파트너입니다.
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MAI network supplier
고급 무균 및 비무균 의약품 제조, 제제 개발 및 분석 테스트를 위한 신뢰할 수 있는 GMP CDMO입니다.
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MAI network supplier
이스라엘 CDMO는 복잡한 합성 의약품 및 화학 기반 의료 기기의 개발 및 GMP 제조를 전문으로 합니다.
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