Strides Pharma gets USFDA okay for Amantadine Hydrochloride Softgel Capsules

Written by MD Bureau Published On 2022-02-21T12:57:20+05:30 | Updated On 21 Feb 2022 12:58 PM IST

Strides Pharma gets USFDA okay for Amantadine Hydrochloride Softgel Capsules

The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Bengaluru: Strides Pharma Science Limited today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has 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.

Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

"The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market," the company said in its recent release.

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

According to IQVIA MAT December 2021 data, the US market for Amantadine Hydrochloride Capsules USP,100 mg is approximately US$ 11 Mn. The company has 271 cumulative ANDA filings with USFDA of which 244 ANDAs have been approved and 27 are pending approval.

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Strides is a global pharmaceutical company headquartered in Bengaluru, India. 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's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida).

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