Our platform is built on FDA-tracked quality: four Type II DMFs, an FDA-inspected manufacturing facility with Green List status, and NDC labeler registration.
Credentials below belong to our manufacturing facility and regulatory registrations.
Type II Drug Master Files on file with the U.S. FDA: Semaglutide (039209), Liraglutide (033912), Tirzepatide (040378), Retatrutide (042689). Letters of Authorization available for customer registration.
The manufacturing facility has been inspected on-site by the U.S. FDA and holds Green List status. [Confirm exact inspection year and status wording before publishing.]
FDA NDC labeler codes 83589 & 83821 — products registered under our labeler identity in the U.S. NDC system.
Production follows current Good Manufacturing Practice with validated processes, qualified equipment and full batch traceability.
Provided with each supply agreement, supporting your product registration and due diligence:
| Document | Purpose |
|---|---|
| Certificate of Analysis (COA) | Batch-specific quality data |
| DMF Letter of Authorization | Enables your regulatory filing to reference the DMF |
| GMP certificate & FDA inspection records | Manufacturing facility compliance evidence |
| [Stability data] | Supports shelf-life assignment and registration |
| Export documents | Invoice, packing list, [certificate of origin] for customs |
Send us your NDA and we will share the full documentation package.
Request Documentation