Losan Pharma GmbH: Contract Development and Manufacturing Organisation (CDMO)
Losan Pharma GmbH is a German-based pharmaceutical technology company that operates as a full-service Contract Development and Manufacturing Organisation (CDMO). Established in 1992, the company???s core business is the development, manufacturing, analytical testing, and packaging of advanced medicinal products for its global partners in the pharmaceutical industry. Its operations are centered at two main sites in Germany: Neuenburg am Rhein and Eschbach.
The fundamental value proposition of Losan Pharma is to provide innovative solutions that enhance Active Pharmaceutical Ingredient (API) performance, a concept summarized by their mission to "make APIs perform". This focus includes improving API stability, optimising bioavailability (especially for poorly soluble compounds), achieving customised or modified release profiles, and ultimately increasing patient compliance through advanced dosage forms. The medicinal products manufactured and developed by Losan Pharma are distributed by their clients in over 70 countries worldwide.
Continue…Core Business and Services
Losan Pharma is a "one-stop shop" CDMO, meaning it provides a comprehensive suite of services covering the entire product lifecycle from concept to commercialisation. These services are broadly categorised as follows:
1. Development Services
* Formulation Development: This is a key area of expertise, focusing on developing new, innovative dosage forms and "Generics Plus" (innovative dosage forms for generic molecules). Services include feasibility studies, compatibility studies, and dissolution studies.
* API Characterisation and Research Support: Providing in-depth analysis of the Active Pharmaceutical Ingredient to guide development.
* Clinical Trial Supply: Manufacturing and packaging of clinical dose forms for use in clinical studies.
* Analytical Method Development and Validation: Creating and validating the necessary analytical methods for quality control and testing.
2. Manufacturing Services
Losan Pharma has the capabilities to manufacture a wide range of medicinal products, including solids, semi-solids, and liquids.
* Solid Dosage Forms: The company offers manufacturing for conventional forms such as tablets (chewable, coated, effervescent, controlled-release retard), hard gelatin capsules, and granulates.
* Advanced Dosage Forms and Multiparticulate Systems: A special focus is placed on innovative formulations designed to improve drug delivery and patient compliance. This includes pellets, mini-tablets, Orally Disintegrating Tablets (ODTs), and effervescent technology.
* Manufacturing Supply Chain: Full service supply encompassing material procurement, technology transfer, process optimisation, and validation.
* High Potency APIs (HPAPI): The Neuenburg facility is equipped to handle APIs up to Occupational Exposure Limit (OEL) class 3b (OEB 4), and the company has a research facility in Frankfurt focused on HPAPI-containing medicinal products.
3. Technology Platforms and Innovation
Innovation is a major driver for Losan Pharma, with significant investment in advanced pharmaceutical technologies to solve complex challenges like poor bioavailability and stability.
* Hot Melt Extrusion (HME): A core technology platform used for manufacturing formulations, often in strategic collaboration with partners like Evonik.
* Nanoparticulate Systems/Nanotechnology: The development and application of nanoparticles and nanoprocessing equipment to enhance the performance of medicinal products.
* Other Advanced Technologies: This portfolio also includes hot melt coating, orodispersible systems, spray drying technology, and the use of mesoporous silica materials.
* Taste Masking: Developing formulations to mask unpleasant tastes in medicines, which directly contributes to increased patient compliance.
4. Packaging and Analytical Services
* Packaging: Offering comprehensive primary and secondary packaging services for various oral solid dosage forms, including blisters, stick packs, sachets, and tubes for effervescent tablets. The Eschbach site features 11 packaging cabinets dedicated to formats like stick packs, blisters, and sachets.
* Analytical Services: Providing a broad range of testing, including method transfer, method validation, stability studies, and Quality Control (QC) for finished products.
* Regulatory and Artwork Services: Supporting clients with regulatory submissions (leveraging their history of successful inspections by international bodies like the US-FDA, European EMA, and Brazilian ANVISA) and providing artwork services.
The company's commitment to quality is underscored by its compliance with global quality requirements, including cGMP regulations, and its history of successful inspections by numerous international authorities. Losan Pharma's operational model focuses on leveraging its advanced technology and experienced team to act as a reliable partner for pharmaceutical companies globally, assisting them in navigating the complexities of modern drug development and manufacturing.
