Strides Pharma Science’s step?down wholly owned subsidiary -- Strides Pharma Global Pte., Singapore, has received tentative approval for Triamcinolone Acetonide Ointment USP, 0.05% from the United States Food & Drug Administration (USFDA).
While it was amongst the few Competitive Generic Therapy (CGT) designated products for Strides, another generic company received approval prior to the company’s approval. Consequently, the final approval for Strides will be effective May 30, 2020 when the company will launch the product.
According to IQVIA MAT data, the US market for Triamcinolone Acetonide Ointment USP, 0.05% is approximately $20 Mn. The product will be manufactured at the company’s Oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market. The company has 102 cumulative ANDA filings with USFDA of which 69 ANDAs have been approved and 33 are pending approval.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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