Amhwa Biopharm Co., Ltd. passed the US FDA inspection without defects!

In October 2024, Amhwa Biopharm Co., Ltd. received the cGMP Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA), and we officially passed the FDA cGMP inspection .

Set sail for a new journey

In September 2024, the US FDA conducted a 5-day cGMP on-site inspection of Amhwa Biopharm. The inspection involved the production and manufacturing of sodium hyaluronate APIs, and the inspection scope covered six major systems: quality assurance system (QS), facilities and equipment system (FS), material system (MS), production system (PS), packaging and labeling system (PLS), and laboratory control system (LS). FDA inspectors spoke highly of our efficient, professional, and rigorous working methods.

Live up to the good times and start again

The official website of the U.S. Food and Drug Administration (FDA) announced that Amhwa Biopharm passed the on-site inspection without defects (No action indicated, "NAI"), indicating that our quality management system has once again been recognized by the international authoritative drug regulatory agency.

We will take this opportunity to always put product quality first, introduce advanced production equipment and technology, establish a sound quality management system, cultivate a high-quality and professional production and management team, and continuously improve production efficiency and product quality to provide strong guarantees for the company's development. In the future, Amhwa Biopharm will actively expand the international market, strengthen cooperation and exchanges with international pharmaceutical companies, continuously enhance its brand influence and market competitiveness, contribute to the development of the global pharmaceutical industry, and provide more and better quality sodium hyaluronate products .

Company Introduction

Founded in 2010, Amhwa Biopharm is a technology-innovative enterprise focusing on the research and development and production of bioactive substances, APIs, medical beauty products and functional skin care products. For more than a decade, it has provided high-quality products and services to many global pharmaceutical, skin care, food, agriculture and other fields. With technological innovation and excellent product quality, it has developed into a global leading hyaluronic acid supplier.

Company Products

Amhwa Biopharm takes hyaluronic acid as its core, and is based on three patented technology platforms: Waterble® microbial fermentation technology, ProEnzy® enzyme cleavage technology, and CrossLink cross-linking. Its product grades cover a variety of specifications including cosmetic grade, food grade, and pharmaceutical grade. It covers a variety of hyaluronic acid derivatives from ultra-low molecular weight to ultra-high molecular weight, from conventional hyaluronic acid to hydrolysis, cross-linking, acetylation, and cationic hyaluronic acid derivatives.