The ProSolus business model is created as a brokerage agent for the development of Transdermal Generic products by a group of pharmaceutical executives comprising William Dixon, Esq. and Anthony Mack. Potential customers seeking ANDA products will be linked up with CDMO’s with ProSolus oversight of all development activities.
- Juan A. Mantelle joins ProSolus
- ProSolus reaches agreement with a major pharmaceutical company to develop two generic prescription products
- The first modification of the business model is implemented wherein ProSolus will be developing the formulations and then brokering and providing oversight for the manufacturing and testing portions of the projects.
- ProSolus establishes a formulation and testing lab in York, Pennsylvania.
- ProSolus signs a development agreement for its first OTC product
- ProSolus signs a development agreement with a second major pharmaceutical company for the development of two additional generic transdermal products.
- Juan A. Mantelle is named CEO of ProSolus.
- ProSolus decides to move its operations to Miami, FL and signs a lease to begin the transition of operations.
- Research and Development as well as Analytical testing labs are built out in the Miami facility and the transition from York is completed.
- ProSolus is one of 30 companies to receive the “Keys to the City of Miami – Dade County”.
- Official inauguration and ribbon cutting ceremony of the Miami facility occurs on December 11th.
- ProSolus business model undergoes a second modification wherein ProSolus will be responsible for the blending and coating operations in addition to the formulation and testing. Packaging operations will still be contracted out and supervised by ProSolus.
- Design of the Miami manufacturing facility begins.
- Permits are issued for the buildout of the Miami facility and construction begins
- Manufacturing facility is completed and Certificate of Use issued.
- Manufacturing of the first commercial product, Lido Flex™, an over the counter 4% Lidocaine product, begins under a license to Richmar Technologies.
- ProSolus secures its Schedule III registration with the DEA.
- Lido Flex™ is launched in the US.
- Pivotal clinical supplies for our first ANDA Schedule III product are manufactured and our commercial partner begins clinical trials.
- Pilot clinical supplies for our second and third ANDA products are manufactured and clinical trials initiated.
- Fourth ANDA project placed on hold due to declining sales of the Reference Listed Product (RLD)
- The third business model modification occurs as Mission Pharmacal decides to invest in partial ownership of ProSolus and add the packaging capabilities to the ProSolus offerings.
- Building layout is designed, permits attained and construction begins on a second, adjacent facility in Miami dedicated to slitting, die-cutting, packaging and warehousing.
- R&D is moved to the newly designed area and Analytical/ QC operations expands into the previous R&D areas.
- Pivotal clinical supplies for the second and third ANDA products are manufactured and packaged in the newly expanded facility.
- Clinical trials begin on the second and third ANDA products.
- The Schedule III ANDA product is filed with the FDA by our commercialization partner.
- Blending, coating and testing of commercial supplies of Lido Flex™ continue. Product rolls are shipped to Richmar for packaging and distribution.
- Mission Pharmacal acquires ProSolus and renames it ProSolus, Inc.
- Clinical trials on the second and third ANDA product continue with Mission Pharmacal.
- The 4% Lidocaine OTC product is licensed for retail distribution and sales to NFI Consumer Products to be sold under the name Lidocare™.
- Lidocare™ manufacturing, packaging and testing for Q1 launch begins.
- Lidocare™ is launched by NFI.
- ProSolus’ first patent is granted in the US.
- Development continues on Anhydroflex™ technology platform meant to provide an alternative to the hydrogel technology.
- Second packaging machine acquired and placed into service.
- Pivotal PK trial for the first Mission product completed successfully.
- Irritation/Sensitization/Adhesion trial of the first Mission product completed successfully. One adhesion trial remaining to be ready for submission to the FDA.
- Lidocare™ manufacturing continues. Alternative permutations being investigated in the R&D sector for product line extensions.
- Mission Pharmacal‘s clinical trials placed on hold.
- ProSolus’ second patent granted in the US.
- Various Anhydroflex™ technology – based OTC products manufactured and placed on formal stability.
- Lidocare™ manufacturing for NFI continues.
- ProSolus, Inc. offered for sale by Mission Pharmacal.
- ProSolus’ third patent granted in the US.
- Canoa, Inc. purchase ProSolus, Inc.
- Revitalized ANDA programs so as to complete pending clinical studies in earnest.
- Strategy is pivoted to focus on white-label manufacturing of Lidocaine and Hemp-Derived CBD products.