The wholly-owned subsidiary of Zydus Lifesciences Ltd, Zydus Worldwide DMCC, has entered into a licensing and supply agreement with Synthon BV for Palbociclib tablets for the US market.
The NSE-listed entity had earlier received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Pimavanserin Capsules, 34 mg and Pimavanserin Tablets, 10 mg.
Under the agreement, Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets, and for the manufacture and supply of the product.
Meanwhile, Zydus will be responsible for commercialisation of the oncology product in the US.
Managing Director of Zydus Lifesciences Ltd., Dr Sharvil Patel said, “The partnership will bring access to a high unmet-need therapy area for patients in the US. We are certain that by pooling our resources and knowledge, we will meet the critical needs of patients and stakeholders.”
Anish Mehta, Chief Executive Officer, Synthon BV said, “We are delighted to partner Zydus on this significant first-to-market opportunity in what is the world’s largest pharmaceutical market. We are confident that working with Zydus will allow us to successfully commercialise Palbociclib, while advancing our mission of enabling access to high-quality, affordable medicines.”
The Zydus Lifesciences stock traded at ₹717.75 on the NSE, up by 1.25 per cent as of 9:30 am on Friday.