Amneal receives first product approval in China
Amneal has received its first product approval in China. Sevelamer carbonate was approved and is expected to launch shortly.
In addition, the company expects to launch oseltamivir phosphate in China this year, upon approval. In total, Amneal has six products pending review in China with more product registrations planned over time. Since 2019, the company has collaborated with Fosun Pharmaceuticals to bring key therapies to market in China.
Amneal’s international expansion strategy focuses on providing access to essential medicines globally. In India, the company is expanding its local product portfolio and utilizing its local infrastructure to commercialize directly. In Europe, China and other countries, Amneal is collaborating with distribution partners to bring Amneal’s FDA approved product portfolio around the world.
[Read more: Amneal touts 26 generic new product launches in 2022
The company has finalized distributor partnerships in over 30 countries and began the product registration process across Middle East, Africa, Latin America and Southeast Asia regions.
Amneal expects international expansion will be a key vector for growth and add $50 to $100 million in revenues by 2027, and scale further over time.
“Sevelamer becomes our first product approval in China and our initial entry into the second largest pharmaceutical market in the world. With our partner, Fosun, we look forward to beginning commercialization this year. At Amneal, we are focused on advancing our internal expansion strategy to bring our portfolio of essential medicines to patients in China and around the world,” said Shyamakant Giri, president of Amneal India Business and Emerging Markets.
[Read more: Amneal debuts 2 generics]