Marksans Pharma manufacturing facility at Verna, Goa has been audited by the United States Food and Drug Administration (USFDA) from April 3 to 7, 2017.

At the end of the inspection, there were 4 observations given under form 483. The company has already started addressing the same and is confident of satisfying the FDA within the stipulated time.

Further, the USFDA has also granted final approval of the Abbreviated New Drug Application for Dutasteride Soft Gelatin Capsules 0.5 mg, which is therapeutically equivalent to the reference listed drug (RLD), Avodart Capsules, 0.5 mg of GlaxoSmithKline. Dutasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The company will launch the product immediately.

Shares of the company gained Rs 4.15, or 7.96%, to trade at Rs 56.30. The total volume of shares traded was 3,914,084 at the BSE (1.06 p.m., Monday).