Marksans Pharma has said the US health regulator has issued four observations after completing the inspection of its Verna facility in Goa.
The United States Food and Drug Administration (USFDA) had inspected the company’s manufacturing facility at Verna, Goa from April 3 to April 7, 2017, Marksans Pharma said in a filing to the BSE today.
“At the end of inspection, there were four observations given under Form 483,” it added.
The company has already started addressing the same and is confident of satisfying the health regulator within the stipulated time, the drug firm said.
The company also said that USFDA has granted final approval for generic Dutasteride soft gelatin capsules in the strength of 0.5 mg. The company plans to launch the product immediately, it added.
The product is indicated for the treatment of symptomatic benign prostatic hyperplasia in men with enlarged prostate, the company said.
Shares of Marksans Pharma were trading at Rs 56.80 per scrip in the afternoon trade on the BSE, up 8.92 per cent from its previous close.