With recent news on very large injectable manufacturing sites closing, there is going to be ever increasing supply chain issues for injectable products. Comodo Health, and it affiliates are striving for reliable and high quality manufacturing of injectables, while maximizing potential revenues with the help of effective channel management, efficient account networking and creative pricing strategies.
Comodo Health currently has a pipeline of injectables for various niche indications that are complementary to each other, mainly in the hospital setting. Please see below a table for the current update.
Drug/Device Combination Products
The development of drug/device combination products involves expanded pre-clinical testing, including “Human Factor Testing” on whether patients can use a device delivery system, such as inhalant, based on clear set of instructions, i.e.; Instructions For Use (IFU). Manufacturing controls and quality systems vary considerably, as does the Package Insert and post-marketing requirements. Design controls for devices and release requirements for drugs apply to the drug/device combination product, which add to the complexity of these type of products. It is also challenging to actually design such device that will be appropriate for delivery of a drug or a combination of drugs.
Comodo Health, and its affiliates own the rights to a patented dry powder inhalation device with the ability to deliver 30 or 60 equivalent doses of micronized drug(s) consistently into the lungs. In fact, a product that uses the same device already is approved by the local regulatory authorities in Europe and has been in the market for the last 5 years. Comodo Health’s development platform is based on this innovative and novel device and currently consists the following products and indications: