US FDA lifts warning letter issued to USV’s Daman facility

The company expects seven ANDA approvals in the near future and are expecting a 40-50 growth in our US business over the next two years

Drug firm USV said that the US Food and Drug Administration (US FDA) lifted its warning letter issued in March 2017 to the Daman facility, following corrective actions taken by the company. USV Daman manufactures aseptic and oral solid dosage products for the US market.

Prashant Tewari, MD, USV said, “We are pleased with this outcome. Our team worked closely to address the US FDA concerns. We will continue to strengthen our quality system through continuous improvement programmes. We expect seven ANDA approvals in the near future and are expecting a 40-50 growth in our US business over the next two years.”

Earlier in November 2017 the USV Lote site, that supplies Active Pharmaceutical Ingredients (API) to US Market, received an audit close from US FDA.