LGM Pharma, a company that sources and distributes active pharmaceutical ingredients (APIs) to pharmaceutical and biotechnology companies, announced the addition of a set of services to expand its offering for companies in the 503B sector.
Under the 503B section added in the Federal Food, Drug, and Cosmetic Act by the US Drug Quality and Security Act in 2013, a compounder can become an outsourcing facility.
Drugs compounded by an outsourcing facility in compliance with this section can qualify for exemptions from the US Food and Drug Administrator (FDA) new drug approval requirements and certain labeling requirements.
LGM’s new services include: market intelligence and marketing support; identification and qualification of high-quality, FDA-inspected API manufacturers; logistics support, such as the importation of APIs in the correct package sizes for the end market; and supplying necessary documentation to fulfill 503B requirements and ensure FDA compliance.
The company’s CEO, Prasad Raje, commented that section 503B companies have ‘distinctive needs’ and added that the services will help its clients expand their market in accordance with end-market requirements and FDA guidelines.
Raje also explained that the services were developed through a partnership with Willow Birch Pharma, a 503B outsourcing facility.
Jimmy Yancy, Founder of Willow Birch, said LGM’s support had been ‘critical’ in increasing API sales to 503B compounding pharmacies.