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

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

USV India

 

The drug firm, USV Private Ltd. said today 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 US FDA 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.

About USV:

USV is a 55 year old leading healthcare company in India. The product portfolio comprises of APIs, Solid Orals, Injectables, Ophthalmics, Biosimilars, Peptides etc. USV markets products globally to regulated markets such as US, Europe, Japan, Korea, Australia and a number of Rest of the World (ROW) countries. In India, USV has been recognized for leadership in the oral anti-diabetic market and cardiovascular diseases segment. It also has a significant presence in the areas of Nutritional Supplements, Dermatology, and Gynaecology. It has access to generic markets through Indicus LLC in USA, USV North America and USV Europe.