USFDA lifts warning letter issued to USV’s Daman facility

Mumbai: The drug firm, USV Private Ltd. said that the US Food and Drug Administration (USFDA) lifted its warning letter issued in March 2017 to the Daman facility, following corrective actions were taken by the company.

USV Daman manufactures aseptic and oral solid dosage products for the US market.

Mr Prashant Tewari, Managing Director, USV Pvt. Ltd. said, “We are extremely pleased with this outcome. Our team worked closely to address the USFDA concerns. We will continue to strengthen our quality system through continuous improvement programs.

We expect 7 ANDA approvals in the near future and are expecting a 40-50% growth in our US business over the next 2 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.