Shilpa Medicare informs about USFDA approval

01 Jan 2019

Shilpa Medicare has informed that the company has received US Food and Drug Administration (USFDA) approval for its ANDA Irinotecan HCL Injection USP, 40 mg/2mL and 100 mg/5mL (20mg/mL) Single Dose Vials. Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum. According to IQVIA MAT Q2 2018 data, the US market for Irinotecan HCL approximately $18 million.

The above information is a part of company’s filings submitted to BSE.

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