Business Model

Landela focuses on four areas in the development of projects:

Strategic Partnerships – Bringing products to the U.S. niche or specialty generic market, assisting partners in qualifying facilities for U.S. FDA approval, out licensing dossiers, and supplying API for vertical integration through our API division FineTech Pharmaceutical, Ltd.

Deal Flexibility – Developing deal structures that are product and/or project specific to meet the needs of our partners. These have included profit sharing, fee-for-service, commission structured, royalty based payments, and traditional project management milestones.

Capabilities – U.S. ANDA filing and regulatory expertise, a network of best in class contract service providers, established relationships in the wholesale, retail, homecare, and hospital distribution chains, experience in chargeback and reimbursement issues, and post-market regulatory maintenance.

Experience - Our team has built strong relationships with customers and partners by providing the highest quality service and value added skills that are unique in Sterile manufacturing and Formulation and Development. Landela has cultivated a global network of contract manufacturers, laboratories, and regulatory/quality consultants. This network is a ready to use, reviewed, and tested network to streamline the timeline and process of dealing with multiple CMOs, instead your team only deals with our team and we manage the day to day issues of a CMO. These service partners are thoroughly reviewed and adhere to the quality agreements managed by Landela in order to provide a seamless and efficient path to development and approval.



 

Business Opportunities

Landela can provide U.S. generic market access for international partners utilizing a proven, low cost model.

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