Strides Arcolab has received the approval from the United States Food & Drug Administration (US FDA) 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. The drug is usually used along with specific diet recommendations and sometimes other medications.
The product will be manufactured at the Company’s Oral dosage facility at Bengaluru and marketed by Strides in the US.
According to IMS data, the US market for generic Calcitriol Softgel Capsules is approximately US$ 50 million, with only three players having approval for both the strengths of Calcitriol.