Pharma
CDMO (Contract Development and Manufacturing Organization) specialising in full-service operations, we offer you a complete range of services: So that we manage all stages of the supply chain for you. With TP&C, the promotion and marketing of your medicines can remain your priority. We take care of everything else! Thépenier Pharma & Cosmetics assists you in your operations of industrial transfers and complex analytical transfers. Our industrial and analytical development teams carry out feasibility studies, scale-ups, the adaptation of production series and analytical processes to our equipment and ensure their validation. We manage all the associated ICH stability studies. We generate the reports necessary to the compilation of the regulatory variation files to be submitted to the regulatory authorities. Subsequently, we ensure the maintenance of the validated status of your products (periodic revalidations, product quality review, etc.). These certifications enable us to produce and deliver medicines (Px and OTC) and medical devices for most of the world's major markets in human and veterinary pharmacy, in full compliance with the most demanding quality standards. We are flexible and can adapt to the specific requirements of our various customers if necessary. Your expectations are rightly high. In order to achieve excellence, we constantly innovate and invest in order to meet your requirements and adapt to constant changes of global industry standards and best practices. Consequently, Thépenier Pharma & Cosmetics displays one of the lowest non-quality rates in the pharmaceutical subcontracting market. For the last 10 years, this rate has been constantly below 0.5%. In addition, the modernity of our equipment, the investment culture of Thépenier Pharma & Cosmetics and the deployment of the most advanced methods of continuous improvement (5S, kaizen, lean, TPM, etc.) allow us improve our productivity rate year after year. In practice, between 2013 and 2020, productivity in our factories has been multiplied by a factor of 2.4. All of our pharmaceutical lines are equipped with serialisation modules. No additional financial costs will be charged for this. We have partnered with Tracelink to ensure that your serialisation requirements are fully compliant with the various related national regulations and to ensure the smooth distribution of your medicines. Our Laboratory can carry out all the physicochemical and microbiological analysis required by your MA (Marketing Authorisations), thanks to state-of-the-art equipment (HPLG, CPG, IR, UV, chromato, etc.), all managed via a LIMS to guarantee the integrity of all handled data. We can also carry out all the analysis required for stability studies and the validation of our manufacturing and cleaning processes. We are constantly monitoring legal and regulatory developments relating to our discipline in France, Europe and around the world. In particular, we can support your MA developments or your regulatory filings with the ANSM (Agence Nationale de Sécurité du Médicament), EMA (European Medicines Agency) and FDA (Food and Drug Administration). Specialists in dermatological products and dedicated to the ENT (nose, throat, ear) sphere, we manufacture, in our factories, the following galenic forms and product categories: Galenic forms: Corresponding to the following pharmaceutical and OTC (Over The Counter) specialties: Using the following packaging formats, in order of quantity produced: Generally speaking, our mixers allow batch sized between 1,500 and 10,000 litres for liquid forms, between 1,000 and 5,000 litres for emulsions and semi-solid products and up to 500 kg for powder forms. We are our own back-up since our tube and bottle lines are interchangeable and guarantee the stability and durability of your productions, as well as a service rate systematically over 80%. For all these reasons, we collaborate with the biggest corporations in the pharmaceutical world and we hope that you will also place your trust in us! Being a pharmaceutical manufacturer for more than 40 years, Thépenier Pharma & Cosmetics (TP&C) has the historical know-how and state-of-the-art equipment to guarantee the success of your projects and the efficient support of your industrial transfers.
Full-Service Subcontractor and Contract Manufacturer
Specialist in Industrial Transfers
GMP and FDA Certified Pharmaceutical Manufacturer
Serialisation
Internalised Physico-Chemical and Microbiological Tests
Proactivity and Regulatory Compliance
Pharma Areas of Expertise
Somewhere Over the Counter
A FLEXIBLE AND ADAPTABLE MACHINERY EQUIPMENT AND ORGANIZATION
At Thépenier Pharma & Cosmetics, we are proud to work for the greater good – people’s health – with pride, dedication and passion!