Cenexi Hérouville Saint Clair

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.

About the plant

This additional site acquired in 2017 from MSD, allowed Cenexi to significantly increase its syringe, vial, and ampoule filling capacity. This site also manufactures creams, ointments, lotions, drops, and syrups to treat allergies, inflammatory and infectious diseases, and cancers. The site has increased its capacity in sterile products in all forms, in particular, by introducing the manufacture of an ophthalmic gel. In December 2021, Hérouville reached a major milestone in its development by obtaining FDA accreditation for the production of a sterile injectable product, aseptically packaged in vials for the USA. It had already obtained accreditations from the Brazilian, French, and Russian health authorities. Finally, the ANSM recently authorized the site to manufacture and certify biological products (immunological and biotechnology). The physicochemistry and microbiology control laboratories also allow on-site analyzes (packaging materials, raw materials, semi-finished products, and finished products).

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• NMPA (China GMP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)

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Activity

• Sterile forms (ophtalmic, nasal, otic), Injectables, Terminal sterilization, Fill&Finish, Tubes, Terminal sterilization, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), 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)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use)
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system
• Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium

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Services

• Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, 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

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