Sterile and ophthalmic

APIs for injectables, eye drops and procedure kits.

Alprostadil, papaverine and phentolamine; lidocaine and prilocaine; vancomycin; bimatoprost and latanoprost; moxifloxacin. Most are in 503B Category 1.

Rows of empty glass serum vials with aluminum crimp caps on a stainless steel tray

Sterile-use data

Mark an item for sterile use on the quote and ask for endotoxin (USP <85>) and bioburden (USP <61>/<62>) data. We'll tell you what's available for the lot before you order.

What we list (32)

503B Category 1 FDA interim policy, conditions applyCategory 2 FDA safety risk, outside the interim policyBiologic not eligible for 503A/503B compoundingWithdrawn list not for human compoundingNo 503B pathway not on the bulks list, the shortage list or in Category 1503A HHS draft policy formVeterinary animal compounding

Status as of Nov 14, 2026. Sources: FDA 503B categories list (updated Mar 21, 2025), FDA Category 2 page (current Apr 22, 2026), 21 CFR 216.24, 21 CFR 530.41, 21 CFR 600.3(h)(6), HHS FR 2026-22192. No item we list is on the 503B bulks list today. Shortage status is checked when we price your request. Labels are a starting point, not a determination for your facility.

Questions

Do you list the trimix APIs?

Yes: alprostadil, papaverine HCl and phentolamine mesylate, all in 503B Category 1.

Can I get endotoxin data?

Ask for it on the quote. Mark the item for sterile use.

Do you list ophthalmic actives?

Yes, including bimatoprost, latanoprost, moxifloxacin and bromfenac. Some Category 1 entries are route-specific; the line notes say so.

Every quote includes

A written price and pack size per item, the lot COA, and each item's FDA status as of the date we price it. Nothing ships until you approve the price sheet.

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