Erlanger, Kentucky, June 24, 2019 – LGM Pharma, LLC, a leader in Active Pharmaceutical Ingredient (API) sourcing, distribution and supply chain management to the pharmaceutical and biotechnology industries, today reported that it is offering an expanded set of value-added services to support its clients who supply APIs to compounding pharmacies under section 503B of the 2013 Federal Food, Drug, and Cosmetic Act (FDCA).
“At LGM Pharma we are committed to providing the highest quality APIs to our Section 503B clients, along with a suite of individualized services to facilitate their use,” said Prasad S. Raje, PhD, CEO of LGM Pharma. “Section 503B companies have distinctive needs, and we are proud that our value-added services have demonstrated the ability to help our clients who supply APIs to compounding pharmacies expand their market in accordance with end-market requirements and FDA guidelines.”
LGM’s unique understanding of the 503B sector has led to the new core service offering in support of 503B outsourcing facilities that includes: 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.
Dr. Raje continued, “We developed these additional service offerings working closely with our 503B outsourcing facility partner, Willow Birch, to support the growth of their business. We look forward to contributing to their continued success, and now to offering our purpose-built service platform to other 503B clients providing APIs to the compounding pharmacy market.”
“At Willow Birch, our mission is to provide high quality APIs to 503B compounding pharmacies that serve patients with unique medical needs,” said Jimmy Yancy, Founder of Willow Birch Pharma. “LGM Pharma has become a trusted supplier, providing expert assistance and management of our API supply chain. This support has been critical to Willow Birch’s success in increasing our API sales to our customers. We expect that LGM’s specialized service offerings will continue to be a key factor in our future growth.”
The 2013 U.S. Drug Quality and Security Act added a new section 503B to the Federal Food, Drug, and Cosmetic Act. Under section 503B, a drug compounder can become an outsourcing facility, defined as: a facility at one geographic location that is engaged in the compounding of sterile drugs; has elected to register with FDA as an outsourcing facility; and complies with all of the requirements of section 503B. Drugs compounded by an outsourcing facility in compliance with section 503B can qualify for exemptions from FDA new drug approval requirements and certain labeling requirements. Outsourcing facilities are inspected by the FDA and must comply with all other provisions of the FDCA, including current good manufacturing practice (CGMP) requirements.
About LGM Pharma
Headquartered in Erlanger, Kentucky, with offices in Florida, New Jersey and Israel, LGM Pharma is an innovation-driven global leader in sourcing, warehousing and distribution of quality CGMP APIs to leading pharmaceutical and biotechnology companies. LGM specializes in streamlining API supply chain management through all phases of R&D, clinical development and commercialization, ensuring technical competence and adherence to clients’ timelines and specifications while providing expert guidance to navigate complex global regulatory submission strategies. For more information, visit lgmpharma.com.
About Willow Birch Pharma
Willow Birch Pharma is a VAWD-accredited, specialty distributor of Active Pharmaceutical Ingredients (APIs) to the U.S. Compounding Industry. Willow Birch provides the compounding industry with the highest quality active pharmaceutical ingredients, with a primary focus on supplying injection grade chemicals to 503B outsourcing facilities that also have an active Drug Master File (DMF) with the U.S. FDA. For more information, visit willowbirch.com.