Shilpa Medicare gets USFDA approval for lung cancer injection Pemetrexed
Pemetrexed injection is used in the treatment of Non-small cell lung cancer and Malignant pleural mesothelioma as approved in the Prescribing Information.
Karnataka: Shilpa Medicare has announced that the company’s New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml & 100 mg/10 ml, Ready to Use formulation is approved by US Food and Drug Administration (US FDA).
This is the first NDA product approval received by the Company under 505(b)(2) application, which is a unique formulation supplied as ready to use product solution. This product is required to be administered intravenously without any further dilution. The product is stable at room temperature. The company has developed Pemetrexed formulation as liquid/ ready to use injection against Lyophilized powder formulation of reference ALIMTA.
The product approval has been received for the application filed from a third party manufacturing site.
The Company has already entered into a commercialization agreement with Amneal Pharmaceuticals LLC for the US Market.
Pemetrexed injection is used in the treatment of Non-small cell lung cancer & Malignant pleural mesothelioma as approved in the Prescribing Information. According to IQVIA MAT Q1 2023 data, the US market for Pemetrexed Injection is approximately USD 735.3 Million.
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Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
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