Strides Arcolab gets US FDA’s approval for Calcitriol Softgel Capsules

16 Dec 2014 Evaluate

Strides Arcolab has received approval from the United States Food & Drug Administration (USFDA) for Calcitriol Softgel Capsules, 0.25mcg and 0.5mcg. Calcitriol is a Vitamin D capsule, used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.

According to IMS data, the US market for generic Calcitriol Softgel Capsules is around $50 million, with only three players having approval for both the strengths of Calcitriol. The product will be manufactured at the company’s Oral dosage facility at Bangalore and marketed by Strides in the US Market.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.

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