Till 01:02 pm; a combined 23.65 million equity shares representing 5.78% of total equity of pharmaceuticals firm changed hands on BSE and NSE. An average sub two million shares were traded daily in past two weeks.
Marksans Pharma today said that the United States Food and Drug Administration (USFDA) inspected the company’s manufacturing facility located in Goa from 3rd to 7th April, 2017.
“At the end of the inspection, there were 4 (four) observations given under Form 483. The company has already started addressing the same and is confident of satisfying the FDA within the stipulated time,” Marksans Pharma said in a regulatory filing.
Further, 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. Marksans will launch the product immediately, it added.
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