Strides Arcolab Limited bagged the US Food and Drug Administration approval for Ergocalciferol capsules USP 1.25 mg. Ergocalciferol is a synthetic calcium regulator for oral administration. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP units of Vitamin D and will be available in bottles of 50 & 100s.

According to IMS data, total US market for Ergocalciferol softgel capsules approximated to US$ 62.9 million in 2009, a growth of 72 per cent over 2008 sales. Over 95 per cent of the market for this product is dominated by one player.

According to Arun Kumar, vice chairman and Group CEO of Strides we are amongst the few soft gelatin manufacturers focussing in the prescription drug domain, and we are delighted with this important & first soft gelatin product approval by the US FDA.

This product will be marketed and sold by Paddock Laboratories Inc under a profit share partnership. Product is expected to be launched immediately.

Ergocalciferol capsules is a synthetic calcium regulator and is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as Vitamin D resistant rickets and familial hypophosphatemia. Synthesis of the major biologically active metabolites of Vitamin D occurs in the liver and kidneys and they promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.