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Strides Arcolab's subsidiary receives USFDA approvals
Source: Capital Market, Thursday, November 24th, 03:39 PM
Onco Therapies, a wholly owned subsidiary of Strides Arcolab has received approvals from USFDA for Carboplatin Injection 10 mg/ mL (Aqueous solution), packaged in 1000 mg/100 mL, Pharmacy Bulk Packages, Oxoliplatin for Injection USP (Lyopholized) packaged in 50 mg and 100 mg single-use vials (Tentative approval) and Oxoliplatin for Injection USP (Lyopholized) packaged in 50 mg and 100 mg single-use vials (Tentative approval).
The company had earlier received approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ 5 mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data, the US market for generic Carboplatin is approximately US$35 million. Carboplatin is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. The company has also received tentative approval for additional strength of Oxaliplatin Injection. According to IMS data, the US market for Oxaliplatin is approximately US$1.4 billion.
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