Built for the supplier file your QA team keeps.
What QA asks a new API supplier, answered on the quote.
- Direct GMP-certified, FDA-inspected supply
- Lot COA with every quote
- Every lot traced, batch to shipment
- Manufacturer documentation under NDA
What comes with every quote
Price sheet
Price and pack size per line.
Manufacturer documentation
Provided directly by the manufacturer under NDA.
Lot COA
For the lot we'd ship, before you order.
Dated status
FDA status per item, with the date checked.
Sterile-use data
Mark an item for sterile use and ask for endotoxin and bioburden data.
Your questionnaire
Returned completed with the quote.
The 503B bulk rules in plain words
By law, a 503B outsourcing facility may compound from a bulk drug substance only if:
- It is on FDA's 503B bulks list. The list is short today: five substances, none of which we list. Or:
- The drug you make from it is on FDA's drug shortage list when you compound, distribute and dispense it.
Separately, FDA has said it does not currently intend to take action over certain nominated substances in "Category 1" if the conditions in its interim policy are met. That's enforcement discretion, not a listing, and FDA can change it. Substances nominated on or after Jan 7, 2025 are not placed in Category 1. Category 2 substances raise FDA safety concerns and are outside that policy.
The bulk substance also needs a valid COA, a manufacturer registered with FDA, and compliance with any USP or NF monograph. A pathway for the API doesn't cover making an essential copy of an approved drug.
Every quote states the status of each item as of the date we price it. Your PIC and QA make the call.
Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503B. Checked Nov 14, 2026.
Our quality commitments
- We check every manufacturer against FDA import alerts and warning letters before we quote.
- No lot is released to you until its COA has been reviewed.
- We notify you in writing of any change of manufacturer, site or specification.
- If there's a complaint, recall or quality issue, we notify every customer who received the lot and keep the record.
Questions
Do I need an account first?
No. Send an item and a work email.
Can I start with one API?
Yes. Many facilities start with their highest-volume item.
How do you check status?
We check FDA's 503B bulks list, the shortage list, the Category 1 and Category 2 lists, the withdrawn-drug list (21 CFR 216.24) and import alerts the week we price your request, and date each line.
Do you supply recurring orders?
Yes. Tell us how often you buy on the quote form and we'll propose a schedule.
503A pharmacy? See For 503A pharmacies.
How it works
- Send one item or your list. API, quantity and, if you like, what you pay now.
- We price and document it. Price, lot COA and dated status, per line.
- Your QA reviews it. Nothing ships until you approve the price sheet.
- We ship the lot you approved, with its paperwork and traceability record.
One item. One written price. Your call.
Send the API you buy most and what you pay now. Nothing ships until you approve the price sheet.