GLP-1 API suppliers, verified by FDA's Green List.
GLP1Suppliers.com is the trusted sourcing partner for a Green-Listed semaglutide, tirzepatide and retatrutide manufacturer — an FDA cGMP-audited facility producing peptide API at ton scale. One inquiry. One point of contact. No back-channel.
The narrow set of suppliers a US compounder can actually import from.
Since FDA's Import Alert 66-80 (Sept 2025), GLP-1 APIs entering the US are detained without physical examination unless the manufacturer appears on FDA's Green List. Our partner is on it — across multiple GLP-1 molecules — and is one of a small number of Chinese facilities to clear an FDA cGMP inspection on commercial-scale peptide.
Legally importable
Listed on FDA's Green List under Import Alert 66-80 for GLP-1 receptor agonist bulk drug substances — not subject to DWPE detention.
Audited at scale
Cleared FDA GMP inspection. NMPA GMP authorized. EU GMP audit on the calendar. Quality system covers the full peptide lifecycle.
Single point of contact
You work with us. We handle introductions, NDAs, sample requests, DMF letters of authorization and contract terms — so you don't navigate the supplier side cold.
Active Pharmaceutical Ingredients
All products below are produced at the same FDA Green-Listed peptide site. DMF and CoA available under NDA.
| API | CAS | Therapeutic area | Status |
|---|---|---|---|
| Semaglutide | 910463-68-2 | Diabetes / weight loss | US DMF · Green List |
| Tirzepatide | 2023788-19-2 | Diabetes / weight loss | US DMF · Green List |
| Retatrutide | 2381089-83-2 | Weight loss | US DMF |
| Cagrilintide | 1415456-99-3 | Weight loss | In validation |
| Orforglipron | 2212020-52-3 | Weight loss (oral) | In development |
| Mazdutide | 2259884-03-0 | Weight loss | In development |
| Lanreotide acetate | 108736-35-2 | Acromegaly | In development |
| Etelcalcetide HCl | 1334237-71-6 | Secondary HPT (hemodialysis) | In development |
| JNJ-2113 / Icotrokinra | 2763602-16-8 | Psoriasis | In development |
| Teduglutide | 197922-42-2 | Short Bowel Syndrome | In development |
| Abaloparatide | 247062-33-5 | Osteoporosis | In development |
| NAD+ | 53-84-9 | Anti-aging / longevity | Available |
Sterile finished dosage forms are available for select non-US markets only and are not offered into the United States. We do not facilitate any transaction inconsistent with the destination market's drug laws.
Built for buyers who get audited.
If your QA, regulatory or compliance team needs to defend a sourcing decision, this is the documentation trail you'll be working with.
- ✓FDA Green List inclusion for GLP-1 receptor agonist bulk drug substances under Import Alert 66-80 — verifiable against FDA's published list.
- ✓FDA cGMP inspection cleared with no withhold-recommendation findings; full establishment inspection report available under NDA.
- ✓US Drug Master Files on file for multiple GLP-1 APIs, with letters of authorization issued to qualified buyers.
- ✓NMPA GMP authorization for commercial peptide API and complex injectable manufacture.
- ✓EU GMP audit on the calendar; Written Confirmation, Halal and Kosher certifications already in place.
- ✓Method validation, stability, ICH-aligned specs and full CoA package per shipment.
Tell us what you need. We'll respond within one business day.
Inquiries are handled confidentially through us. We'll respond with indicative pricing, lead time, supporting documentation and the path to a sample. Compounding pharmacies (503A), licensed distributors, contract manufacturers and registered importers welcome.
We do not respond to anonymous addresses or unverifiable buyers. A business email and company name are required.
What buyers usually ask first.
If your question isn't here, send it via the form above.
Why won't you publish the manufacturer's name?
Because we add value as a sourcing partner, not as a directory. Once we've confirmed you're a qualified buyer with a real use case, we make introductions, share the FEI / DMF references, and route the commercial conversation. Tire-kickers and competitors don't get past the front door.
Is the API legal to import into the United States?
Yes — for the listed GLP-1 molecules, the manufacturer is on FDA's Green List under Import Alert 66-80, which is the current pathway for legally importing GLP-1 bulk drug substance. Buyers are still responsible for their own facility registration, drug listing, and 503A/503B compliance.
Do you sell finished injectable products into the US?
No. Finished GLP-1 dosage forms (Wegovy / Ozempic / Mounjaro analogues) are not offered into the United States. The originator products are patent-protected in the US and unapproved foreign-made copies cannot be lawfully imported. Finished products are only available in select markets where the regulatory and IP position permits it.
What's the typical lead time and minimum order?
Sample-scale (research grams) ships in days. Commercial kg-scale typically 4–8 weeks depending on documentation and QC release. We'll quote exactly once we know the molecule, volume and destination.
Can you send a DMF letter of authorization?
Yes, for buyers filing an ANDA, NDA or 505(b)(2). LOAs are issued by the manufacturer once a supply agreement is in place; we coordinate the request.