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

N-Acetyl-L-Cysteine
API & Food Grade

CAS 616-91-1 · ChP, USP, EP, BP, AJI. DMF (ChP / USP / EP), Written Confirmation and COPP available.

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A Plant That
Passed ANVISA

Five-day on-site GMP inspection by Brazil ANVISA, closed with zero defects.

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Registered in
Korea · Europe · Brazil · India

Our manufacturing base holds completed product registrations with MFDS (Korea), EDQM / EMA (Europe), ANVISA (Brazil) and CDSCO (India).

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Audits Welcome
Two Weeks' Notice

Bring your QA team. We open our workshops, QC centre and documentation room.

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DMF · WC · COPPDocumentation available
GMP / EU WCEU GMP / WC
KR · EU · BR · INGlobal registrations
2 weeksAudit response
Product Portfolio

Cysteine Series & Amino Acid APIs

Supplied as raw material only — pharmaceutical (API) and food grade.

Flagship Product

N-Acetyl-L-Cysteine — CAS 616-91-1

Supplied as a white crystalline powder in pharmaceutical (API) and food grades. Every batch is released with a Certificate of Analysis and is traceable to synthesis and QC records.

CH3CONHCHCH2SHCOOH
CAS No.616-91-1
Molecular formulaC5H9NO3S
Molecular weight163.20 g/mol
PharmacopoeiaChP · USP · EP · BP · AJI
GradePharmaceutical (API) · Food grade
AppearanceWhite crystalline powder
AssayWithin current pharmacopoeia limits
Packing25 kg fibre drum (PE liner)
DocumentsCOA · MSDS · DMF · WC · COPP
Verifiable Compliance

Certificates & Regulatory Documents

Listed with status, so you know exactly what exists today and what is in progress.

Certificates on fileClick to view. Full scans available on request under NDA.
National High-Tech Enterprise (GR202533008197)National High-Tech Enterprise (GR202533008197)
Zhejiang Zhejiang "SRDI" (Specialized & Innovative) SME
Drug Master File (ChP / USP / EP)Available
Written Confirmation (WC) — EUAvailable
COPP (Certificate of Pharmaceutical Product)Available
GMP CertificateAvailable
CTD Module 3 (S.1–S.7)Available
Stability data — ICH Q1A (Zone II & IVb)Available
TSE / BSE & GMO free statementAvailable
ICH Q3C / Q3D & nitrosamine assessmentAvailable
ISO 9001 / 14001 / 45001Available
Halal statement (certificate in application)Available
CEP (EDQM)In application
Kosher certificateIn application

Certificates not held or no longer valid are not listed. Items under application are marked as such.

Trusted by established buyers

A sample of our established customers

Leading pharmaceutical companies across South Asia source NAC and amino acid APIs from our GMP production base.

Square Pharmaceuticals PLCBeximco Pharmaceuticals PLCIncepta Pharmaceuticals Ltd.Eskayef Pharmaceuticals Ltd.UniMed UniHealth Pharmaceuticals Ltd.Opsonin Pharma Ltd.Drug International Limited

Company names are shown for reference only and do not imply endorsement or an active contract.

Verification, not claims

Numbers you can check before you buy

Every figure below can be verified against a document. We would rather show certificates than adjectives.

850 t/a installed capacityTotal annual capacity across the API workshops of the manufacturing base.
Grade D clean areaFinal purification, drying, blending and packing are carried out in a Grade D cleanroom.
ANVISA GMP inspection passedInspected by the Brazilian health authority in July 2025 with a zero-defect outcome. Certificate No. 0137263/24-4.
National High-Tech EnterpriseCertificate No. GR202533008197, valid until December 2028.
ISO 9001 · 14001 · 45001Certified quality, environmental and occupational health & safety management systems.
Dedicated QC laboratoryOn-site HPLC, GC, microbiological testing, stability studies and a retain-sample programme.
Zhejiang specialised SMERecognised as a provincial “specialised and sophisticated” SME with a provincial R&D centre.
API production licenceLicence No. Zhe 20060465 issued by the Zhejiang Medical Products Administration, valid to June 2031.

Capacity, facilities and certifications listed above are held by Zhejiang Hichi Pharmaceutical Co., Ltd., our manufacturing base. Zhejiang Sino Hichi Pharmaceutical Co., Ltd. is its sales entity for N-acetylcysteine.

Factory Track Record

Registrations Held by Our Manufacturing Base

Completed product registrations for iodixanol and iohexol — evidence that this plant is regularly inspected by foreign authorities.

India — CDSCO / DCGIAvailable
Brazil — ANVISAAvailable
Europe — EDQM / EMA & national authoritiesAvailable
South Korea — MFDS (K-DMF filed)Available

ANVISA — Five-Day Inspection, Zero Defects

A five-day on-site GMP inspection by Brazil's ANVISA was closed with zero deficiencies. Together with EU GMP and the Written Confirmation, it is the fastest way for a new buyer to judge whether our manufacturing base can hold your specification.

  • 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.

The sales company of Zhejiang Hichi Pharmaceutical Co., Ltd. – listed on China's NEEQ (834402) and controlled by Beijing Beilu Pharmaceutical (Shenzhen ChiNext: 300016).

Audit

Audits Welcome

We are a real manufacturer, not a trading desk. Customer audits, third-party audits and remote documentation reviews are all accepted.

Please notify us at least two weeks in advance so we can reserve the line, the QC centre and the responsible engineers.

Book an Audit

Book a Supplier Audit

  1. Send scope & preferred dates
  2. We confirm agenda within 2 working days
  3. On-site or remote audit
  4. Findings & CAPA follow-up
Manufacturing

Our Plant

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

5 GMP workshops
1,600 m² QC centre — HPLC, GC, LC-MS
12,700 DCS control points (Yokogawa CENTUM-VP)
Sealed pipeline process, full data traceability
See the plant before you audit itProduction, clean corridors and the QC laboratory at our manufacturing base in Taizhou, Zhejiang. Photos from the facility — not stock images.
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
Markets

Where We Supply

Export documentation prepared per destination.

Markets →

News

Latest

Exhibitions, technical notes and regulatory updates.

2026-10
CEP application for N-Acetylcysteine in progress
EDQM review ongoing. Interim supply is supported by DMF, WC and COPP.
2026-09
Technical note: controlling particle size in NAC crystallisation
Why sealed-pipeline crystallisation gives tighter and more repeatable particle size distribution.
2026-08
ANVISA inspection closed with zero defects
Five-day on-site quality system inspection at our manufacturing base.
Where we exhibited in 2026Three CPHI shows — Shanghai, Bangkok and Shenzhen.
16–18 Sep 2026
CPHI & PMEC Shenzhen 2026Shenzhen Convention & Exhibition Center (Futian), China · Booth 9N29
8–10 Jul 2026
CPHI South East Asia 2026Queen Sirikit National Convention Center (QSNCC), Bangkok · Halls 1–3
16–18 Jun 2026
CPHI & PMEC China 2026SNIEC, Shanghai, China · Booth W3H32

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.