Gland Pharma secures US FDA approval for $1.6B Sugammadex injection

Gland Pharma has received US FDA approval for its Sugammadex injection, a product that recorded approximately $1.6 billion in US sales for the twelve months ending April 2026.

The approval coincides with a strategic contract development and manufacturing organisation (CDMO) agreement between Gland Pharma and a global pharmaceutical firm. The deal covers 55 stock-keeping units (SKUs) to be manufactured across three of Gland Pharma’s sites. The partnership is projected to generate annual revenues of $90–100 million once fully commercialised.

Under the CDMO model, Gland Pharma will provide end-to-end services, including technology transfer, process development, scale-up, validation, and commercial manufacturing. Technology transfer activities are expected to be completed within two years, with revenue generation slated to begin in calendar year 2029. The portfolio includes oncology and non-oncology products in various presentations, such as vials, lyophilised formulations, ampoules, and pre-filled syringes.

The agreement strengthens Gland Pharma’s position as a global CDMO partner, offering integrated development and manufacturing solutions for sterile injectable products.