Our pharma division will operate three subsidiaries: API (“Active Pharmaceutical Ingredient”) Supply, Manufacturing of Drug Products, and 503b Sterile Compounding. Our pharma division will operate three subsidiaries: API (“Active Pharmaceutical Ingredient”) Supply, Manufacturing of Drug Products, and 503b Sterile Compounding.
• API Supply – Qualified Pharma Ingredients, Inc. (‘QPI’), our joint venture subsidiary, will supply “pre-qualified” API’s to drug manufacturers and compounders. Pre-qualified API’s are tested for potency, purity and stability throughout the life cycle of the product. This model reduces pharmacy risk, creates cost savings, and generates revenue opportunities, all while establishing the highest level of patient safety. QPI will initially validate its business plan through Athena and its strategic partnership network of 11 compounding pharmacies with an agreement to sell $600,000 in product. Completion of this plan will then allow us to expand using QPI’s contract with DynaLabs for co-branding and marketing of their Continuous Quality Improvement program to promote QPI products to its network of 1,500 pharmacies.
• Manufacturing – Through our partnership with an API supplier, we have identified multiple DESI (Drug Efficacy Safety Implementation) products, which we will have contract manufactured. Through this relationship, we have established sales channels to distribute these products. DESI products are not subject to the rigorous standards of approval set forth by the FDA, making them quick to market without the need to perform clinical trials.
• 503b Sterile Compounding – BioBlue built a state of the art facility 503b Sterile Compounding. The facility has ISO rated clean rooms and numerous general chemistry, manufacturing, and testing laboratories. This facility will be ISO compliant as well as FDA, DEA and State licensed. The company has the opportunity of establishing its brand recognition and foothold into the pharmaceutical manufacturing market. This foothold and recognition will assist our efforts in the end goal of formulating Stem Cell products that have indications readily available to the U.S. market.
Establishing the distribution channels for these three pharma operations has an added benefit as it allows us to leverage internal resources and knowledge for the commercialization of our own Regenerative Medicine and Blue Technologies products. The BioBlue pharma team has more than 120 years of combined experience and diverse backgrounds in manufacturing, product development and sales. Additionally, this team has taken multiple new drugs through the FDA’s approval process which resulted in numerous successful product launches.