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

Our Plant

A 4.98-hectare site (49,767 m²) with 47,518 m² of total floor area · CNY 490 million invested.

Zhejiang, ChinaLocation
49,767 m²Site area (4.98 ha)
47,518 m²Total floor area
CNY 490 millionInvestment
296Employees
49 (11 QA · 33 QC · 5 management)Quality team
36 months (stability-backed)Retest period
Purified water only — no organic solventsFinal purification

Site and floor areas from public project filings; staff and quality-team figures as of 2025.

Site overview

N-Acetylcysteine is manufactured at the production site of Zhejiang Hichi Pharmaceutical (NEEQ: 834402), controlled by Beijing Beilu Pharmaceutical (Shenzhen ChiNext: 300016). The site runs dedicated API workshops with independent quality-control laboratories.

ANVISA — Five-Day Inspection, Zero Defects

InspectionFive-day on-site GMP inspection, 13-18 July 2025
OutcomeClosed with zero deficiencies
CertificateANVISA GMP No. 0137263/24-4 · scope: iohexol
Decision date1 September 2025

Source: announcement 2025-023 of Zhejiang Hichi Pharmaceutical (NEEQ: 834402) and announcement 2025-097 of Beijing Beilu Pharmaceutical (300016), both dated 2 September 2025. Certificate holder: Zhejiang Hichi Pharmaceutical Co., Ltd. – our manufacturing base.

Inside the plant

Workshops, reactors, utility systems and quality-control laboratories at the manufacturing site.

Plant exterior, Taizhou site
Plant exterior, Taizhou site
Synthesis & reaction area
Synthesis & reaction area
Stainless steel tank farm
Stainless steel tank farm
Production workshop
Production workshop
Grade D clean corridor
Grade D clean corridor
QC laboratory — HPLC/GC
QC laboratory — HPLC/GC
QC laboratory — wet analysis
QC laboratory — wet analysis
Utilities & process control
Utilities & process control
Registration and inspection records on this page refer to the manufacturing site. Product-specific registrations held by the site cover its iodinated contrast agent series, not N-Acetylcysteine.
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