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Seans 218 udogodnienia
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Hiszpania

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Zakłady produkujące produkty do wstrzykiwania (lyo i płyn) oraz płynne.

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

VIVEbiotech
Hiszpania

VIVEbiotech

VIVEbiotech

Twoje wiodące CDMO z certyfikatem GMP, przeznaczone wyłącznie do produkcji wektorów lentiwirusowych.

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

ProBio CDMO | Biologics Platform
Chiny

ProBio CDMO | Biologics Platform

Probio

Globalne GCT i leki biologiczne CDMO, przyspieszające proces przejścia od genu do rynku komercyjnego.

Region: APAC

Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)

Batch Size: Large, Small, Medium

Use: Human

Category / Product: BIOLOGICS

Cultiply
Hiszpania

Cultiply

Cultiply

Hiszpańskie CDMO, które opracowuje procesy produkcji i oczyszczania rekombinowanych białek, enzymów, DNA i innych produktów pochodzenia biologicznego.

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)

EVER Pharma Jena GmbH
Niemcy

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

Specjalistyczne CDMO do opracowywania i produkcji małocząsteczkowych preparatów do wstrzykiwań.

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), Reszta świata

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

ALPHAVET Zrt.- Bábolna Manufacturing Plant
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

Sidefarma
Portugalia

Sidefarma

Sidefarma SA

CMO specjalizuje się w produkcji małych i średnich serii dla firm farmaceutycznych na całym świecie na rynkach regulowanych.

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

Rioja Nature Pharma
Hiszpania

Rioja Nature Pharma

Rioja Nature Pharma SL

CDMO NUTRACEUTYKI/SUPLEMENTY ŻYWNOŚCI.

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

Indena Settala
Włochy

Indena Settala

Indena

Placówka zgodna z GMP i kontrolowana przez FDA, specjalizująca się w złożonych API i związkach o silnym działaniu do OEB 6.

Markets: TGA (Australia), Reszta świata, 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)

Batch Size: Small, Medium, Large

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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

Compliance: NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)

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

Region: Europe

Use: Human, Veterinary

Category / Product: CHEMICAL-SYNTHETIC

Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)

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

Region: Europe

Compliance: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Batch Size: Small

Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

CZ Vaccines | Large Scale Plant Spain
Hiszpania

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

Jednorazowa waga komercyjna

Markets: EMA (EU)

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

Region: Europe

Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

Batch Size: Large, Medium

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones

Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

Cellex Cell Professionals
Niemcy

Cellex Cell Professionals

Cellex Cell Professionals

Zakład produkcji ogniw CDMO CGT i centrum gromadzenia materiałów wyjściowych

Markets: EMA (EU), FDA (USA)

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

Region: Europe

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

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2

Category / Product: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS

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