Shilpa Medicare gains on getting USFDA`s approval for New Drug Application for Pemetrexed Injection
Shilpa Medicare is currently trading at Rs. 244.90, up by 1.10 points or 0.45% from its previous closing of Rs. 243.80 on the BSE.
The scrip opened at Rs. 243.80 and has touched a high and low of Rs. 245.35 and Rs. 242.80 respectively. So far 10308 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 470.00 on 24-May-2022 and a 52 week low of Rs. 222.40 on 28-Mar-2023.
Last one week high and low of the scrip stood at Rs. 261.25 and Rs. 242.80 respectively. The current market cap of the company is Rs. 2128.82 crore.
The promoters holding in the company stood at 50.01%, while Institutions and Non-Institutions held 14.28% and 35.71% respectively.
Shilpa Medicare has received U.S Food and Drug Administration (USFDA) approval for its New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml & 100 mg/10 ml, Ready to Use formulation. 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.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications