On April 20, 2017, an inspection notification was received from Chinese office of FDA (United States Food and Drug Administration) by our company. It stated that FDA would perform an on-site inspection to Southwest No.2 Pharmaceutical Factory Co., Ltd. on April 25-28. Under the time pressure, our company quickly communicated with the factory and organized an audit team. A timely and effective improvement for the factory’s quality system was made, all the quality risks were controlled in a short time, a perfect plan for this audit was properly established. Through our company’s hard work and the factory’s active preparation, we passed this flight inspection successfully.
New Milestone – Moxidectin NDA to treat River Blindness registration in FDA
Breaking news: under our support on API moxidectin supply, DMF filing and US FDA audit, our client from Australia, a not for profit biopharmaceutical company, has submitted a New Drug Application to the FDA for moxidectin for the treatment of river blindness. Our client received funding for this project from the Global Health Investment Fund which is backed by the Bill and Melinda Gates Foundation, and has a mandate to supply moxidectin to those in need, mainly in Africa. This important submission will help our company to be the leading supplier of moxidectin so we look forward to many more business opportunities.