Semaglutide API for US Buyers: Check FDA Import Alert 66-80

Lawful use runs through ANDA (abbreviated new drug application, the generic filing) development, 503B (FDA-registered outsourcing facilities compounding larger batches) and 503A (state-licensed pharmacies compounding for individual patients). ANDA development is open, 503B is proposed to close, and 503A carries the least oversight of the API.

HCPLive reported the Apotex tentative approval, and Apotex announced it. A tentative approval means the product meets the scientific and regulatory requirements but cannot be marketed until patents or exclusivities lapse. Our inference: ANDA teams buying today are buying for development, not for launch.

The 503B bulks list names the substances outsourcing facilities may compound from. In its 30 April 2026 announcement, FDA attributed to Commissioner Marty Makary the position that outsourcing facilities cannot lawfully compound from bulk substances when approved drugs are available, unless there is a clear clinical need. The announcement set a comment deadline of 29 June 2026. As of October 2026 we have found no final determination, so check the Federal Register notice before buying.

Section 503A of the Federal Food, Drug, and Cosmetic Act exempts qualifying state-licensed pharmacies compounding for individual patients from CGMP, as FDA's compounding laws page explains. As Import Alert 66-80 notes, this includes the requirement that the API meet specifications for impurities or potency. Outsourcing facilities under 503B remain subject to CGMP.

We supply semaglutide as bulk API or raw powder to business and institutional buyers, not as finished vials. Regulatory status and permitted end use are set product by product, and buyers confirm import authorization and permitted end use before commercial supply.

Import Alert 66-80 lets FDA detain GLP-1 API shipments without physical examination (DWPE) unless the product and manufacturing site are on the alert's Green List. The site, not the seller, decides whether a shipment clears. FDA treats these APIs as drugs under the Federal Food, Drug, and Cosmetic Act, subject to CGMP.

The alert also records a pattern of sites that register as GLP-1 API makers, offer material for import, refuse FDA's records requests and then deregister within a short period. A trading company can therefore sit between you and a site that has never been checked.

FDA's page shows each Green List entry with the firm name blacked out, so we counted entries, not firms. On the page as published 9 October 2026, we counted the country-headed entries (21) and, within them, the entries listing product code 61P[][]72, FDA's code for semaglutide.

The 3 Indian entries list liraglutide (2) and exenatide (1). The list changes, so check the live alert at every order.

We publish this page. Aarise Pharmaceuticals does not claim any of these entries, and as of October 2026 we do not publish a Green List listing for our semaglutide source, so we make no claim of US FDA standing for it. We confirm the manufacturing source and site name in the quotation, and you should match it against the live alert before ordering.

The alert says FDA divisions "may" detain, so a site that is not listed is not barred. Our recommendation: do not commit commercial volume until you have matched the batch's manufacturing site against the list. A firm petitions for listing with certificates of analysis for its last ten API lots, release specifications, stability data, process validation, batch records and out-of-specification results. Ask any supplier for the same evidence.

The approved drugs contain semaglutide, and FDA states that the sodium and acetate salts are different active ingredients. Semaglutide carries CAS number 910463-68-2 (a Chemical Abstracts Service registry number). Ask each supplier to state the form in writing.

FDA's page on unapproved GLP-1 drugs is direct: "These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs." It adds that FDA is "not aware of any lawful basis for their use in compounding."

A quote that says only "semaglutide API, 99%" leaves this open. A purity figure says nothing about the form.

Run five gates in order and stop at the first fail. Each is a test with a pass and a fail, and the first three cost nothing, so run them before you request samples.

Label claims are not evidence. In a 2024 peer-reviewed study, researchers made six test purchases from illegal online pharmacies. Three injection vials arrived, and measured semaglutide purity in the vials purchased ranged from 7.7% to 14.37% against 99% on the labels. That was a small purchase of finished products, not API from business suppliers, so it does not describe API suppliers generally. It does show why you test the batch. For the wider audit, use our peptide API supply chain qualification checklist.

A request for quotation (RFQ) should carry the product and CAS number, quantity, destination, grade or purity, required documents, payment terms and Incoterms (international shipping terms). Add the form, use route and batch status so the quote can be checked against the five gates.

Product:          Semaglutide API, CAS 910463-68-2
Form:             state base or salt
Quantity:         evaluation / pilot / commercial (kg)
Grade or purity:  specification you require
Use route:        ANDA development / 503B / 503A / other
Destination:      country and importer of record
Incoterms:        e.g. CIF, DAP
Documents:        COA, specification, SDS, manufacturing site name
                  and address, impurity profile, stability data
Batch status:     released stock / made to order
Payment terms:    proposed terms
Company details:  legal name, address, contact

This is how we handle it. You send the RFQ, and we check availability and sourcing options against your quantity, specification, destination and documents. We then send a commercial quotation that names the manufacturing source and site. We share the COA, specifications and SDS where applicable. After you approve an evaluation sample, we support commercial and bulk supply, with order, documentation and export coordination after confirmation. Our peptide raw material catalog lists semaglutide among our peptide APIs.

Pricing follows current rates and is quoted product by product, so we do not publish a single price. Minimum order quantity (MOQ) is confirmed at quotation, and the lead time is stated in the quotation or proforma invoice. In-stock material can ship sooner than made-to-order. Evaluation quantities go to qualified business buyers, with sample size, price and documents confirmed per product. For international commercial orders, payment terms are generally 100% advance by bank transfer unless alternatives are agreed in writing.

Send your RFQ through our contact page and choose Product Information.