Strides Arcolab receives USFDA approval for vitamin C softgel capsules

The US Food & Drug Administration (USFDA) has granted approval to Strides Arcolab Limited for Calcitriol softgel capsules, 0.25 mcg and 0.5 mcg. According to IMS data, the US market for generic Calcitriol softgel capsules is approximately $ 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.
 
Calcitriol is a vitamin D capsule, used in patients with kidney disease who cannot 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.