Cenexi SAS
Accueil Sites Osny. Acquired in 2011, the Osny site specializes in the development and production of highly active solid pharmaceutical forms (hormonal and allergens). This 4,000 m2 pharmaceutical plant located 36 km northwest of Paris employs around a hundred people.
About the plant
This site´s tablet and capsule development and manufacturing capacities are used to manufacture the hormonal and anti-allergenic products Cenexi supplies to the pharmaceutical sector. The site is also home to a dozen of the 110 experts of Cenexi Services*, the entity supporting formulation activities, analytical and pharmaceutical form developments, industrial transfer, and regulatory support for experimental products or products already on the market to be manufactured on Cenexi sites. They are grouped within the Development Center for solid oral forms specialized in highly active products (allergens and hormones) and complex processes (controlled release, microdosing). This center is composed of a non-GMP area for the manufacture of test batches, a GMP area (white room) for the manufacture of pilot batches and clinical batches and finally an analytical development laboratory.
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
Activity
- Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- DEA: N/A
- BSL:
- Therapeutic areas: (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens
- Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), NMPA (China), ANVISA (Brazil), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support
Address: 17, rue de Pontoise 95520 Osny
France
Year: 2000
Other plants of this company
Cenexi SASGMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.
Cenexi Hérouville Saint ClairThe Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquid products. It has a pharmaceutical surface area of 17,900 m2 over 10 hectares and employs 290 people.
Cenexi Laboratoires ThissenThis 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*. It specializes in the production of sterile highly potent injectables, mainly against cancer.
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