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Cenexi Laboratoires Thissen
Belgium

Cenexi Laboratoires Thissen

Cenexi

This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

BSL (Biological Safety Level): 3, 4, 1, 2

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), MHRA (UK), MFDS (South Korea), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

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, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Korott - EVP Iberia
Spain

Korott - EVP Iberia

Korott - EVP Iberia

We are specialists in the development and manufacturing of food supplements: capsules, sticks, doypacks, powders and vials.

MARKETS: EMA (EU), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), ANMAT (Argentina), INVIMA (Colombia)

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

REGION: Europe

COMPLIANCE: BRCGS, ISO, IFS, World Health Organization (GMP / HACCP)

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, NUTRACEUTICALS

USE: Human

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V06) Nutrients

STE PRASFARMA
Spain

STE PRASFARMA

STE PRASFARMA

CMO/CDMO cytostatics and high potency 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

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CHEMICAL-SYNTHETIC manufacturing site

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Pharma CRO/CMO

Location available after registration

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CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

An API and Interemediate manufacturer having global certifications.

Location available after registration

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BIOLOGICS manufacturing site

MAI network supplier

GMP-compliant biologics manufacturing facility specializing in recombinant enzymes and proteins.

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