France Europe
Cenexi SAS
GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.
About the plant
70 % of turnover is related to the manufacture and packaging of injectable ampoules in different formats, from 1 to 25 ml, with a production capacity of 300 million ampoules/year.
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
Activity
- Oral solids / OSD, Injectables, Tablets, Hard capsules, Terminal sterilization, Fill&Finish, Glass ampoules, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- DEA: Schedule I (high potential for abuse / no medical use)
- BSL:
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, 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, 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, Storage, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support
Get in touch
Cenexi Hérouville Saint Clair
The 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 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.
Cenexi Laboratoires Thissen
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*. It specializes in the production of sterile highly potent injectables, mainly against cancer.
Address: 52, rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois, France
France
Year: 2004
Other plants of this company
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 SASAccueil 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.
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.
Contact the CDMO commercial and technical team directly
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