Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers

“We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, chief executive officer of Shorla. “Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.”

“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”

Rayna Herman, chief commercial officer of Shorla added, “At Shorla, every innovation is driven by our commitment to put patients first. IMKELDI is another step forward as we continue to expand our growing portfolio with products that prioritize accessibility and affordability.”

Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, is a vertically integrated, manufacturer and distributor of drugs to global markets; specializing in the Oncology therapeutic segment and introducing novel drugs.