- CEO Alex Oshmyansky said the company is primarily functioning as a 503B compounding pharmacy targeting drugs on the FDA shortage list. He said having this focus will allow it to “be more agile and address drug shortages as they arise.”
- Operating as a 503B compounding pharmacy means the company will be less regulated than typical generic drug companies. However, the company will be required to register with the FDA as an outsourcing facility, be inspected by the agency and follow certain manufacturing requirements.
- The company is planning to begin generic drug manufacturing at a Houston-based plant, which Mr. Oshmyansky said is about half-way constructed.
- The company is also planning to launch its own pharmacy benefit management company.
- Mr. Oshmyansky said the company is taking a biologics license application through the FDA approval process for a product it plans to make at the Houston plant, but he’s not disclosing what that product is yet.
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