Emerging Opportunities for Manufacturers in China and the 503B Space
As the pharmaceutical industry continues to evolve, participants must constantly look at new developments to stay ahead of the curve. Many changes are often rooted in government regulation and public scrutiny. Pharma Solutions has partnered with two private firms to help manufacturers capitalize on emerging opportunities in China and the 503B space.
Looking Abroad: Opportunities in China
The China Drug Administration underwent a reorganization in March 2018. A previous complete overhaul in 2013 better organized governmental regulation of the food and pharmaceutical industries. Although there has been recent public pressure from the general population due to bad vaccines, China has usually taken a hardline stance on the protection of health. As recent as 2007, Zheng Xiaoyu, the former head of China’s State Food And Drug Administration, was executed for taking bribes from various firms in exchange for state licenses related to product safety.
With the restructuring really beginning to take hold, new initiatives that directly affect the industry are being embraced. One major aspect is the introduction of patentable drug products – until now, there was little to no enforcement on the introduction of generics. A second major aspect is that the CDA requires new drug files to be approved, in line with an increased focus on quality. In August 2018, Blackstone invested $400 million into a Chinese drug manufacturer so that it can more quickly acquire drugs and other pharmaceutical products in its pursuit of growth and profitability.
If you own drug files (ANDA, NDA or 505b2 pathways), Pharma Solutions can help coordinate the launch of your product for the Chinese market through a Joint Venture partnership – with little to no cash investment.
Capitalizing on the 503B Outsourcing Facility Trend
503B Outsourcing Facilities is a working solution to the drug shortage problem implemented by the FDA since 2012. Although there is economic opportunity, Facilities must comply with CGMP requirements, be inspected by FDA according to a risk-based schedule and meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
Now, companies are taking advantage of the developing opportunity: with the provision allowing Facilities to bypass FDA approval requirements, a product can be brought to market in as little as 30 days. To give a glimpse of what is at hand: Sagent Pharmaceuticals announced a contract valued up to $1 billion with SterRx, a 503B compounding facility founded just 6 years ago. The 503B compounding facility has been manufacturing, packaging, and distributing product in synergy with Sagent’s fully developed sales and marketing activities.
If you have established sales and marketing channels, Pharma Solutions can help coordinate the development and manufacturing of new products and business lines.
About Us
Based just outside of Philadelphia, Pharma Solutions provides actionable guidance and excellent administrative services with a focus on client care across Compliance, Commercial, and Quality solutions. Our mission is to improve the health and welfare of the American public by providing solutions and implementing best practices for companies in the pharmaceutical supply chain.
0 Comments