Premium API & Pharmaceutical Solutions — Made in China, Delivered Globally
Xi'an Hailinuo Biological Technology Co., Ltd. delivers premium Active Pharmaceutical Ingredients (APIs), pharmaceutical excipients, and end-to-end project support including documentation systems, machinery troubleshooting, spare-part sourcing, and GMP training — serving pharmaceutical manufacturers across the Middle East and beyond.
Founded in 2020, Xi'an Hailinuo Biological Technology Co., Ltd. is headquartered in Xi'an, Shaanxi — a historic capital and a growing technology hub in western China. We bridge international pharmaceutical expertise with regional execution, helping manufacturers across the Middle East and beyond achieve quality, compliance, and operational excellence.
SOP systems, batch records, risk assessments (FMEA), validation master plans (VMP), IQ/OQ/PQ protocols, CAPA frameworks, and data integrity systems — all aligned with cGMP requirements.
Internal and external quality audits, deviation and OOS management, cleaning validation, documentation governance, and QMS optimization programs.
cGMP/GMP training (on-site & online), regulatory submissions (dossiers, variations, renewals), audit preparation, change control, and continuous improvement.
From documentation to production line commissioning, we cover the full pharmaceutical lifecycle — trusted by manufacturers across the MENA region.
Active Pharmaceutical Ingredients (APIs), pharmaceutical excipients, specialty raw materials from trusted Chinese vendors, with vendor qualification, compliance documentation, and end-to-end logistics.
SOP systems, batch manufacturing records, risk assessments (RA-ENG, FMEA), validation master plans, IQ/OQ/PQ protocols & reports, CAPA systems, and data integrity frameworks.
Expert diagnostics for filling & capping machines, FFS soft-bag lines, sterilizers (steam/water bath), WFI & PW systems. Root-cause analysis and corrective fixes to minimize downtime.
Turnkey line scoping & URS preparation, FAT & SAT support, installation, commissioning & qualification (IQ/OQ/PQ), performance qualification and line optimization.
On-site & online cGMP/GMP training, regulatory submissions (dossiers, variations, renewals), audit preparation & response, change control, continuous improvement.
Internal/external audits, deviation & OOS management, cleaning validation protocols, documentation governance, and QMS optimization projects.
Xi'an Hailinuo Biological Technology Co., Ltd. has been independently audited and certified to the ISO 9001:2015 Quality Management System standard.
As registered with the State Administration for Market Regulation of China.
These items require approval from relevant authorities before conducting business activities.
We welcome inquiries from pharmaceutical manufacturers, trading partners, and collaborators worldwide — especially across the MENA region.
1617, Building B, Huadi Jinzuo
Daming Palace Street, Weiyang District
Xi'an, Shaanxi, China
Mon – Fri: 9:00 AM – 6:00 PM
(China Standard Time, UTC+8)