Strides Arcolab's Calcitriol softgel capsule gets USFDA nod

Written By Unknown on Selasa, 16 Desember 2014 | 21.04

The company has received approval from the USFDA for Calcitriol softgel capsules in the strengths of 0.25mcg and 0.5mcg, Strides Arcolab said in a statement.

Strides Arcolab  has received approval from the US drug regulator for Calcitriol softgel capsules used for treatment of patients with kidney disease who have vitamin D deficiency.

The company has received approval from the United States Food & Drug Administration (USFDA) for Calcitriol softgel capsules in the strengths of 0.25mcg and 0.5mcg, Strides Arcolab said in a statement.

"According to IMS data, the US market for generic Calcitriol softgel capsules is approximately USD 50 million, with only three players having approval for both the strengths of Calcitriol," it added.

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The product will be manufactured at the company's oral dosage facility at Bengaluru and marketed in the US market, Strides Arcolab said.

"Calcitriol is a Vitamin D capsule, used in patients with kidney disease who can't make enough of the active form of Vitamin D... It is usually used along with specific diet recommendations and sometimes other medications," it added.

Strides Arcolab scrip closed at Rs 888.75, down 3.57 percent, on the BSE.

Strides Arcolab stock price

On December 10, 2014, Strides Arcolab closed at Rs 888.75, down Rs 32.95, or 3.57 percent. The 52-week high of the share was Rs 999.00 and the 52-week low was Rs 343.80.


The company's trailing 12-month (TTM) EPS was at Rs 645.04 per share as per the quarter ended September 2014. The stock's price-to-earnings (P/E) ratio was 1.38. The latest book value of the company is Rs 273.80 per share. At current value, the price-to-book value of the company is 3.25.


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