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Shilpa Medicare-Zydus Lifesciences JV Secures USFDA Approval 

IMKELDI, a liquid formulation of the cancer drug imatinib.

Shilpa Medicare, in partnership with the Zydus Group through their joint venture Oncosol, and its collaborator Shorla Oncology, announced on November 27 that the USFDA has approved IMKELDI, the first oral liquid form of imatinib for treating certain types of cancers.

IMKELDI, a liquid formulation of the cancer drug imatinib, is designed to slow or inhibit the growth of specific cancers and gastrointestinal tumors (GIST). Shilpa Medicare highlighted that despite the proven clinical efficacy of imatinib, patient adherence has been a challenge, emphasizing the importance of a liquid oral delivery system to address this need.

Sharon Cunningham, chief executive officer of Shorla said, “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.”

The company recently reported robust results for the September quarter, with consolidated net profit surging 28% quarter-on-quarter and an impressive 1014% year-on-year to Rs 18 crore. Revenue from operations grew 17.5% sequentially and 10% annually, reaching Rs 344 crore. Shilpa Medicare has also achieved eight consecutive quarters of sequential growth in EBITDA.

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