Strides Pharma Science Limited said in an exchange filing that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA).
The stock is currently trading at Rs471.50, up by Rs4.85 or 1.04% from its previous closing of Rs466.65 on the BSE.
The product will be manufactured at the company’s flagship facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market, the pharma company said in the filing.
The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals Inc.)
According to IQVIA MAT data, the US market for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg is approximately US$ 16 mn.
The company has 123 cumulative ANDA filings with USFDA of which 84 ANDAs have been approved and 39 are pending approval, it added.
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