Strides Pharma Science subsidiary receives USFDA nod on Amantadine Hydrochloride Softgel

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte., Singapore, received approval for Amantadine Hydrochloride Softgel Capsules USP, 100 mg from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals, Inc (Endo).

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg is approximately $11 million. The product will be manufactured at the company's facility at Bengaluru (Karnataka) and will be marketed by Strides Pharma Inc. in the US market.

The company also has approval for Amantadine Hydrochloride tablets and the combined market size of tablets and capsules together is approximately $21 million as per IQVIA MAT December 2021 data.

The company has 271 cumulative ANDA filings with USFDA of which 244 ANDAs have been approved and 27 are pending approval.

On a consolidated basis, Strides Pharma Science reported a net loss of Rs 126.66 crore in Q3 FY22 as compared to a net profit of Rs 35.16 crore in Q3 FY21. Net sales declined 4.5% to Rs 794.39 crore in Q3 FY22 over Q3 FY21.

Shares of Strides Pharma Science fell 1.40% to Rs 359.80 on BSE. Strides Pharma Science is a global pharmaceutical company. The company mainly operates in the regulated markets and has an 'in Africa for Africa' strategy along with an institutional business to service donor‐funded markets. The company focuses on difficult to manufacture products that are sold in over 100 countries.

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