Seans 36 udogodnienia
Indie
Hikal Ltd | Bangalore, India
Hikal Ltd.
Rozwój procesu cGMP, zwiększanie skali i produkcja małocząsteczkowych API, NME i półproduktów od gramów do ton.
Category / Product: COSMETICS, NUTRACEUTICALS, SERVICES, CHEMICAL-SYNTHETIC
Batch Size: Large, Small, Medium
Use: Human, Veterinary
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, TGA (Australia GMP), ECOVADIS, EMA (EU GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Reszta świata
Services: Development services, Manufacturing services
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (N) Nervous system, (V06) Nutrients, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (C) Cardiovascular system
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)
Region: APAC
Węgry
ALPHAVET Zrt.- Bábolna Manufacturing Plant
Alphavet Zrt.
Zakład posiada certyfikat GMP UE i produkuje weterynaryjne produkty lecznicze dla 18 państw członkowskich UE i 7 innych krajów europejskich spoza UE.
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
Markets: EMA (EU), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
Region: Europe
Compliance: FDA (cGMP), IFS, Halal Research Council, UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), EMA (EU GMP), World Health Organization (GMP / HACCP), NSF
Category / Product: NUTRACEUTICALS
Use: Human, Veterinary
Services: Manufacturing services
Batch Size: Medium
Niemcy
Aenova Group - Location Tittmoning, Germany
Aenova
Centrum Kompetencyjne, zakład produkujący duże ilości konwencjonalnych materiałów stałych.
Markets: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
Region: Europe
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)
Batch Size: Large, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Szwajcaria
Aenova Group - Location Sisseln, Switzerland
Aenova
Centrum Kompetencyjne złożone konwencjonalne ciała stałe.
Region: Europe
Markets: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
Compliance: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Niemcy
Aenova Group - Location Regensburg, Germany
Aenova
Centrum Kompetencyjne silne substancje stałe (onkologia) konwencjonalne substancje stałe – specjalistyczne produkty półstałe i płynne.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Niemcy
Aenova Group - Location Marburg, Germany
Aenova
Centrum Kompetencji kompleks konwencjonalnych substancji stałych i narkotyków.
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities
Region: Europe
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Szwajcaria
Aenova Group - Location Kirchberg, Switzerland
Aenova
Centrum Kompetencji Miękkie kapsułki żelatynowe.
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), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
Irlandia
Aenova Group - Location Killorglin, Ireland
Aenova
Centrum Kompetencyjne w zakresie suszenia rozpyłowego i peletek o zmodyfikowanym uwalnianiu.
Markets: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
Region: Europe
Compliance: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)
Stany Zjednoczone
Aenova Group - Location Greensboro, USA
Aenova
Centrum Kompetencyjne Pakowanie Materiałów Stałych.
Services: Logistics, Manufacturing services, Packaging
Markets: FDA (USA), Health Canada (Canada)
Compliance: FDA (cGMP), Halal Research Council, Health Canada (Canada GMP), NSF
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS
Use: Human
Region: North America
Rumunia
Aenova Group - Location Cornu, Romania
Aenova
Centrum kompetencyjne i kompleksowy sklep z miękkimi kapsułkami żelatynowymi i VegaGelami®.
Region: Europe
Markets: FDA (USA), Health Canada (Canada), TGA (Australia)
Compliance: FDA (cGMP), ISO, Halal Research Council, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)
Niemcy
Aenova Group - Location Bad Aibling, Germany
Aenova
Centrum Kompetencyjne Opakowania blistrowe Opakowania innych producentów Produkcja dużych ilości substancji musujących.
Markets: EMA (EU), FDA (USA)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, IFS, EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
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)
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