Pharma and medical devices
With 60 years’ experience as a pharmaceutical manufacturer, Thépenier Pharma & Cosmetics (TP&C) offers historic expertise and state-of-the-art equipment to guarantee the success of your projects and provide effective support for your industrial transfers.
As a full-service subcontractor and co-contractor, we offer a complete range of pharmaceutical services, including :
- Regulatory support
- Industrial transfer
- Analytical transfer
- Sourcing
- Sourcing
- Manufacture
- Packaging
- Quality control of packaging items, raw materials and finished products
- Liberation
- Shipping
In other words, we manage every stage of your supply chain.
With TP&C, you can concentrate on promoting and marketing your medicines, while we take care of the rest!
We specialise in complex industrial and analytical transfers. Our industrial and analytical development teams carry out feasibility studies and prototypes. They also adapt production runs and analytical processes to our equipment and ensure their validation. In addition, we manage all associated ICH stability studies. We also generate the reports required for regulatory variation dossiers submitted to the supervisory authorities. We then maintain the validated status of your products, including periodic revalidation and product quality review.
As a GMP (Good Manufacturing Practice) and FDA (Food and Drug Administration) certified pharmaceutical manufacturer, we are authorised to produce and deliver prescription and over-the-counter medicines and medical devices to most of the world’s major human and veterinary pharmaceutical markets, in strict compliance with the highest quality standards. We are flexible and adaptable to the specific requirements of our customers.
We are constantly committed to innovation and investment with a view to achieving excellence. As a result, we are able to respond precisely to your requirements. We adapt to the constant evolution of best practice and global industry standards.
What’s more, the modernity of our equipment, our culture of investment and the deployment of advanced continuous improvement methods enable us to improve our productivity rate every year. Between 2013 and 2020, productivity in our plants will have increased by a factor of 2.4.
All our pharmaceutical lines are equipped with serialisation modules, at no extra cost to you. We work with Tracelink to ensure that your serialisation needs are fully aligned with the relevant national regulations. In this way, we ensure the smooth distribution of your medicines.
We have an in-house laboratory to carry out physico-chemical and microbiological analyses for your Marketing Authorisations. Using state-of-the-art equipment such as HPLC, CPG, IR, UV, etc., all your data is processed in an integrated way via a LIMS, guaranteeing the integrity of your results. We can also carry out all the analyses required for stability studies and validation of our manufacturing and cleaning processes.
Our areas of pharmaceutical expertise focus mainly on dermatological products and products for the ENT sphere (nose, throat and ear). We manufacture a range of galenic forms and product categories, including :
- W/O, O/W emulsions
- Suspensions
- Liquids
- Pasty forms
- Powder forms
In addition, we also produce pharmaceutical specialities and OTC (Over The Counter) products such as medicated toothpastes, mouthwashes, cough and cold remedies, gastroenterological medicines, local dermatological products, topical products for joint and muscle pain, and anti-parasite products. We use different packaging formats such as tubes (aluminium and plastic), bottles (glass and plastic), airless systems, jars and sachets, depending on the quantities produced.
Our production facilities can be adapted to suit the batch sizes specified in your marketing authorisations. Our mixers enable us to produce batches ranging from 1,500 to 10,000 litres for liquid forms, from 1,000 to 5,000 litres for emulsions and pastes, and up to 500 kg for powder forms. We also provide our own back-up with interchangeable packaging lines for tubes and vials. This guarantees the stability and continuity of your production, with a service rate systematically in excess of 80%. We have established partnerships with some of the biggest companies in the pharmaceutical sector, in the hope of earning your trust too.
