Dynamic News

New Milestone – Moxidectin NDA has received approval of US FDA

We are proud to announce that our Moxidectin project has achieved a new milestone:
The New Drug Application (NDA) of Moxidectin for treatment of the orphan disease river blindness has been approved by the US FDA this week. The product was developed by Medicines Development for Global Health, an independently funded biopharmaceutical company that focuses exclusively on neglected diseases, while the Moxidectin API is supplied by Pharmax and manufactured by Livzon Group. The successful approval of the New Drug Application represents a joint success of MDGH, Pharmax and Livzon who have been working hard together for years, and the first approval of moxidectin for use in humans.
MDGH received funding for this project from the Global Health Investment Fund, and plans to supply Moxidectin to those in need, mainly in Africa. We believe the new moxidectin product will bring health benefits to people in both developing and developed world.

  Jul 24, 2018   Dynamic News   Read More

Pharmax Assisted Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd. to Pass the FDA Flight Inspection

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.

  Jan 25, 2018   Dynamic News   Read More

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.

  Jan 03, 2018   Dynamic News, Uncategorized   Read More