Seans 48 udogodnienia
Hiszpania
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
W pełni zintegrowane rozwiązania CDMO do opakowań typu Blow-Fill-Seal (BFS), sterylnych wielodawkowych, niesterylnych wielodawkowych, saszetek, kapsułek i table
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (V01) Allergens
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Francja
Cenexi SAS
Cenexi
Witryny Accueil Osny. Przejęty w 2011 roku zakład w Osny specjalizuje się w opracowywaniu i produkcji wysoce aktywnych stałych postaci farmaceutycznych.
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)
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), MFDS (South Korea)
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (G) Genito urinary system and sex hormones
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
BSL (Biological Safety Level): 3, 4
Controlled Substances: High potential for abuse & medical use
Compliance: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Category / Product: FDF / DRUG PRODUCTS
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Opracowywanie i produkcja leków w postaci stałej doustnej (OSD), donosowej, inhalacyjnej oraz sterylnych suchych proszków i płynów.
Lokalizacja dostępna po rejestracji
Ograniczony widok
COSMETICS manufacturing site
MAI network supplier
Kompleksowe rozwiązania CDMO dla APl i kluczowych półproduktów.
Lokalizacja dostępna po rejestracji
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Główny zakład produkcyjny Lannetts znajduje się w Seymour w stanie Indiana i obejmuje zakłady produkujące doustne dawki stałe (OSD) i płyny.
Lokalizacja dostępna po rejestracji
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