The Rs 670 crore Mumbai based USV Ltd, the leading player in the anti-diabetic therapeutic segment has announced that its solid formulations facility at Daman has received US FDA approval. The company has filed four ANDA's in the US through Indicus Pharma LLc, its affiliate company.
The company's Daman facility was earlier approved by National Agency for Medicines, Finland for supplies to the European Union. Lifestyle therapeutic segment is a focus area for the company. USV already has a US FDA and TGA approved API facility at Chiplun and the company is the largest manufacturer and supplier of metformin in the world.
Commenting on the US FDA approval, Prashant Tewari, managing director, USV Limited said, "As an organisation, we focus on specialisations and offering a complete basket of products to our customers in the segments that we operate in. We were already exporting API's for the US market and the approval for our formulations facility will further boost our plans for the US market." On the current developments at the company, he said, "We have established a dominant position in India in the lifestyle therapeutic segments of anti-diabetics and cardiovascular. For the global market, based on our strengths to be reliable supply chain partners, we look forward to working with both generic and innovator companies for the US and other regulated markets. Our exports currently, contribute 33 percent of our revenues and we are looking at increasing its contribution further."
The company enjoys strong leadership position in the anti-diabetic and cardio-vascular segments in India. Based on its marketing strength, USV has entered into a number of in-licensing deals with foreign based pharmaceutical companies. The domestic business currently provides 66 per cent of the revenue while 33 per cent comes from international business. Generics for North America are marketed through Indicus PharmaLLC, a US based affiliate and for the Europe and the rest of the through business collaboration.