Quality-verified APIs, reliable delivery, and documentation you can trust.
Willow Birch Pharma helps compounders ensure a quality and reliable supply of APIs. We are licensed as a drug wholesaler in all 50 states, DEA-registered, and NABP-accredited since 2007.
Who We Support:
- 503A compounding pharmacies
- 503B outsourcing facilities
- Hospital & health-system pharmacies
- Veterinary compounders
- Compounders nationwide
We source exclusively from FDA-registered, cGMP-compliant manufacturers that are independently audited and continuously monitored to ensure quality and supply continuity.
Our team and manufacturing partners ensure seamless customs clearance, delivery, and regulatory documentation – with valid NDCs and complete COAs for each lot. DMFs are available for many products.
Why Supplier Choice Matters
FDA quality assurance inspections are returning to pre-pandemic levels with increased scrutiny of foreign manufacturing sites, especially for India and China.
The FDA’s latest Report on the State of Pharmaceutical Quality highlights quality concerns among API manufacturers that supply the compounding market.
Over the past five years, 72% of actions (warning letters/import alerts/regulatory meetings) were taken against API manufacturers that exclusively supply compounding pharmacies, even though these sites account for only 18% of API manufacturers in the FDA’s Site Catalog. As inspection frequency increases, the FDA has prioritized these higher-risk sites for future surveillance.
Are Your Top APIs De-Risked from Increasing FDA Scrutiny?
Ask our team for a no-cost supplier risk assessment on your top products. If you are not 100% confident your supplier will pass a quality assurance inspection from the FDA, your supply chain may be at risk.
Willow Birch can help you find a qualified source and de-risk your most important APIs.
Willow Birch Quality & Service Commitments
- FDA-registered, cGMP manufacturers only
- Valid NDCs on every API
- COAs included, DMFs available
- Independently audited, continuously monitored manufacturers
- Pre-qualified alternative sources
- Seamless customs clearance & dependable delivery
- Experienced and proactive service with a single point of contact