Strides Pharma receives USFDA approval for Triamcinolone Acetonide Ointment USP, 0.05%
Bengaluru/IBNS: Strides Pharma Science Limited (Strides) announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Triamcinolone Acetonide Ointment USP, 0.05% from the United States Food & Drug Administration (USFDA).
The product is part of the niche and small volume product portfolio with limited competition in the US market, the company said in its release.
Triamcinolone Acetonide Ointment 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Quoting IQVIA MAT data, the company said the US market for Triamcinolone Acetonide Ointment USP, 0.05% is approximately US$ 15 million.
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 company has 124 cumulative ANDA filings with USFDA of which 86 ANDAs have been approved and 38 are pending approval.
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug. ..
Strides, listed on the BSE Limited and National Stock Exchange of India Limited, is a global pharmaceutical company headquartered in Bangalore, India.
The company’s global manufacturing sites are located in India- Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy- Milan, Kenya- Nairobi and United States-Florida.