Strides announces US FDA approval for Ergocalciferol Capsules 1.25mg

First approval for a soft gelatine product

Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration has granted 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% over 2008 sales. Over 95% of the market for this product is dominated by one player.

Arun Kumar, Vice Chairman and Group CEO of Strides stated: “Strides is 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. 

About Ergocalciferol Capsules
It 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.

Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin D, and hypervitaminosis D. Hypersensitivity to Vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases Vitamin D must be strictly restricted.  In Vitamin D resistant rickets the range between therapeutic and toxic doses is narrow.

About Strides Arcolab Limited:
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company’s website at www.stridesarco.com.