Strides Shasun’s wholly owned subsidiary Strides Pharma Global has received approval for Nystatin and Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food & Drug Administration (USFDA). This is the first topical approval received from the new semi solids block at the flagship plant in Bangalore.
The topical product line is an important new addition to Strides’ portfolio of oral solid dosage products and the Bangalore manufacturing plant supports several current and future topical submissions for the US Market. The product received approval within ten months under the GDUFA regime.
According to IMS data, the US market for Nystatin and Triamcinolone Acetonide Ointment USP, 0.1% is approximately $18 million. The product will be marketed by Strides Pharma Inc. in the US Market.
Strides Shasun (formerly known as Strides Arcolab) is engaged in manufacturing, sale and export of pharmaceutical products. It offers general tablets, hard gelatin and soft gelatin capsules, sachets, potent drugs and semi-solids.
