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.
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 a device that will be appropriate for delivery of a drug or a combination of drugs.
Comodo Health has been working on obtaining U.S. approval for a patented dry powder inhalation device with the ability to deliver 30 or 60 equivalent doses of micronized drug(s) consistently into the lungs.