Our services for contract manufacturing of injectable products

As part of our pharmaceutical contract manufacturing activities for health products (CMO), we act on behalf of several small, medium and large companies in our sector as a partner in the development and manufacturing of their injectable drugs and sterile medical devices. As a contract manufacturer, we support you both in pilot-scale development and the upscaling stages of your proprietary drugs as well as later in the industrial production phase.

GMP Approved

A manufacturing site for injectables compliant with GMP standards

Our production site, located in the Centre Val de Loire region of France, meets the latest standards in force in our industry, in particular, EU GMP and ISO 13485. Our site is regularly audited by both the French authorities (ANSM – French National Agency for Medicines and Health Products Safety) and our various partners. This means that, as part of the pharmaceutical contract manufacturing agreement, you can benefit from unique expertise in the manufacture of injectable drugs.

For pharmaceutical companies with a marketing authorisation (MA) or acting as an operating company, the use of a pharmaceutical contract manufacturer offers multiple advantages :

  • the customer benefits from the industrial expertise of the contract manufacturer.
  • by outsourcing the manufacturing, the customer can focus on development and operations activities.
  • a contract manufacturer such as CDM Lavoisier can also operate the drug, handling its marketing and distribution to customers.
CDM Lavoisier

Expertise acquired over the long term

As an independent SME, the size of our structure allows us to adapt quickly to your needs and so reduce the time to market. CDM Lavoisier has been a major player in industry contract manufacturing for decades. Our business has existed since 1888. By entrusting your project to our group, you benefit from expertise developed over the long term through various outsourcing partnerships.

Our highly responsive structure is able to adapt to extremely specific needs in terms of filling, packaging and quality control.

Pharma contract manufacturing

A broad range of products and services

As a subcontractor, we offer a wide variety of products and services and have full control of the entire process, from pharmaceutical development through to the production of industrial batches.

We can process several parenteral and liquid pharmaceutical products, including glass ampoules, plastic ampoules and glass vials. Our production capability is tailored to the management of products that can handle terminal sterilisation and for batch sizes ranging from a few thousand to several hundred thousand units.

Our teams’ expertise is the key to our quality. We are constantly refreshing it through regular training. Our involvement starts from the search for the sourcing of the raw materials and continues through to the delivery of the finished product.

Glass vial contract manufacturing

A contract manufacturing agreement tailored to your needs

Over the years, CDM Lavoisier has established itself as the specialist in the contract manufacturing of injectable drugs in France. But our role can extend far beyond manufacturing. As each project is different, our service offer is tailored to the needs of each customer :

  • Registration of your MA dossier in France with the ANSM (French National Agency for Medicines and Health Products Safety) and in Europe ;
  • Management of interactions with health authorities (ANSM, HAS [French National Authority for Health], CEPS [French Economic Committee for Health Products], etc.) ;
  • Development and validation of analytical methods ;
  • Manufacturing of pilot batches and industrial batches ;
  • Distribution of your drugs to hospitals and community pharmacies.
Contract manufacturing of glass ampoules

Contract manufacturing of glass ampoule

This line is used to manufacture standard sterile solutions.

  • 1, 2, 5, 10 and 20 mL ampoules.
  • Batch sizes : 80 – 1,800 L
  • Form C open-funnel ampoules, labelled or screen-printed
  • Terminal sterilisation with superheated water
  • Secondary packaging :
    • PVC tray or blister
    • Cardboard carton
  • 100% automatic visual inspection
  • 100% automatic integrity controls

Annual Capacity

18 M

ampoules

Contract manufacturing of plastic ampoules

Contract manufacturing of plastic ampoule

This line is used to manufacture conventional sterile solutions

  • 5, 10 and 20 mL ampoules, with lower volumes as of 2023
  • Batch sizes : 450 – 1,800 L
  • Terminal sterilisation with superheated water
  • 100% human visual inspection
  • 100% automatic integrity controls

Annual Capacity

16 M

ampoules

Contract manufacturing of glass vials

Contract manufacturing of glass vial

This line is used to manufacture conventional sterile solutions

  • 125, 250, 500 and 1,000 mL vials with a 32-mm diameter
  • Batch sizes : 500 – 12,000 L
  • Terminal sterilisation with superheated water
  • 100% human visual inspection
  • Secondary packaging :
    • Cardboard holder
    • Corrugated cardboard box

Annual Capacity

5 M

vials

Development of injectable solutions

Development of injectable solutions

As part of your development activities, we are able to produce test batches and validation batches.

  • Analytical development
  • Development and validation of methods: HPLC, AAS, potentiometry, UV spectrometry, etc…
  • Stability studies : We are able to design and carry out stability studies for registration or post-marketing monitoring in accordance with ICH storage conditions.

CDM Lavoisier offers the following services :

  • Storage under ICH conditions (in-house at 25°C/40% RH and at 40°C/≤25% RH, outsourcing at 30°C
    and at 5°C)
  • Forced degradation studies
  • Container-content interaction studies (extractables and leachables)
  • In-house microbiology studies
Pharmaceutical regulatory support

Pharmaceutical regulatory support

As part of your registrations, we are able to assist you in writing your module 3 in CTD format as well as your variation dossiers.

Pharmaceutical development

Management of development projects

With the support of our development department, we set up smooth and effective communication with your teams in order to coordinate the stages of your industrialisation project :

  • Sourcing of raw materials (API).
  • Definition of the manufacturing process and the terminal sterilisation cycle.
  • Production of pilot batches (testing and registration).
  • Creation of quality control methods.
  • Sourcing of primary and secondary packaging items.
  • Adaptation of the industrial equipment to meet your packaging needs.
Pharmaceutical distribution

From contract manufacturing to pharmaceutical distribution

At our Chaussée Saint-Victor plant, we are involved in the development, manufacture and marketing of various injectable drugs on behalf of other pharmaceutical companies. Our position on the French medicinal product market allows us to offer other pharmaceutical companies a quick entry point to distribute their products to wholesalers, as well as to hospitals via calls for tenders as part of a pharmaceutical in-licensing contract. We are particularly keen on building a lasting relationship based on equality and mutual respect.