N-Acetylcysteine (NAC) & amino acid APIs · GMP plant · DMF / WC / COPP available
Sales: +86 187 2164 5330 angela@hichibiopharma.com
Products

N-Acetyl-L-Cysteine (NAC) Buying Guide

What to check before you buy NAC in bulk — specification, grade, regulatory filings and supply reliability.

1 · Confirm the grade and standard

NAC is supplied as pharmaceutical (API) and food grade. The API grade meets ChP / USP / EP, while the food grade meets FCC / AJI. Tell your supplier which pharmacopoeia edition your market requires — this determines the assay method and the limits applied.

2 · Check the regulatory filing

For EU and regulated markets, verify that your supplier holds the documents your registration dossier needs: DMF (ChP / USP / EP), a Written Confirmation (WC) for the EU, COPP, GMP certificate and stability data. Missing filings can delay your own market approval.

3 · Ask about quality systems

Look for GMP-compliant manufacturing, full batch traceability and release against current pharmacopoeia limits. Our production site passed a zero-deficiency ANVISA (Brazil) inspection, and NAC is produced in a sealed pipeline with 12,700 DCS control points.

4 · Verify supply reliability

Ask about lead time, MOQ, sample policy and packaging. We support gram-level samples through to full containers, ship with COA and MSDS, and can arrange audits with two weeks' notice.

Ready to get a quotation for NAC?

Send us your specification — quotation within 24 hours

Tell us grade, pharmacopoeia, quantity and destination. We reply with COA sample, MSDS and a price proposal.