In-licensing of injectable solutions
CDM Lavoisier, a recognised player in the manufacture and distribution of injectable drugs in France, regularly forges partnerships with third-party companies in the health sector. These partnerships can take different forms: assignment of marketing authorisation (MA) file, distribution agreement, etc…
What is in-licensing?
When CDM Lavoisier enters into an in-licensing agreement with a third party, the partner agrees to grant CDM Lavoisier the right to use a drug in a well-defined territory. This definition is not to be confused with out-licensing where the situation is reversed : CDM Lavoisier then grants a third-party company an operating licence for one of its products.
What are the different types of in-licensing contracts ?
In France, there are 3 stakeholders in the marketing of any drug :
- The Marketing Authorisation (MA) Holder.
- The product manufacturer which may be the MA holder, a contract manufacturer or the pharmaceutical operating company.
- The operating company which markets and distributes the drugs.
For most of its drugs, CDM Lavoisier is both the pharmaceutical firm holding the MA, the manufacturer and the operating company. Under an in-licensing contract with a partner, several set-ups are possible :
- The partner sells its MA file in exchange for the payment of royalties. CDM Lavoisier then becomes the MA holder, manufacturer and operating company for this drug.
- The partner enters into an operating agreement and continues to manufacture the products. CDM Lavoisier then only takes care of drug marketing and distribution through a license.
- The partner enters into a manufacturing and operating agreement. In this context, CDM Lavoisier manufactures drugs and then distributes them again with a license.
The benefits of an in-licensing agreement with CDM Lavoisier
By concluding a partnership with CDM Lavoisier, your company opens the doors to a new market. The French drug market is somewhat complex to understand. Before the first sales, the pharmaceutical firm must go through numerous administrative steps. CDM Lavoisier can carry out all these steps within the framework of the in-licensing contract :
- Registration of the CTD file with the ANSM (French National Agency for Drugs and Health Products Safety).
- Obtaining approval from the Haute Autorité de Santé (HAS – French National Authority for Health) for drugs marketed in hospitals.
- Negotiation of the reimbursement price with the CEPS (Economic Committee for Healthcare Products) for drugs covered by social security.
Beyond the registration of the product, CDM Lavoisier can also ensure the local manufacture in its plant in La-Chaussée-St-Victor (for the following pharmaceutical forms : glass vials, glass ampoules and injectable plastic ampoules).
What types of products are sought ?
CDM Lavoisier mainly manufactures and operates injectable solutions. For other types of products (powder, tablets, etc.), when a licence agreement with CDM Lavoisier would not be appropriate, we can put you in touch with one of our partners for the French territory.
CDM Lavoisier’s partners under licence agreements
Pharmaceutical firm looking for a distributor for France (or Europe)
Biotechnology company looking for an operator capable of manufacturing and/or marketing
Owner of MA files (investment funds, business development intermediary, etc.) seeking a partner for manufacturing and/or distribution
CDM Lavoisier’s main strengths for a successful partnership
A well established and central player in the French market
CDM Lavoisier is a French pharmaceutical firm founded in 1888. Our company is one of the leaders on the community and hospital pharmacies market for injectable drug products.
A highly comprehensive offer
CDM Lavoisier offers a wide-ranging partnership including the contract manufacturing of injectable drugs, the exploitation of the marketing authorisation and the marketing of the products.
A trusted long-term partner
Our company is a dynamic SME. Our agile structure allows us to be extremely responsive in multiple scenarios. Our partnership agreements are established over the long term in a balanced manner.
Contact us to discuss your project
Looking to market an injectable drug in France ? Feel free to contact us to discuss your project :