InvestorQ : How do you assess the impact of the new ANDA approvals received by Granules India?
Mitali Bhutta made post

How do you assess the impact of the new ANDA approvals received by Granules India?

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3 months ago
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Granules India, the Hyderabad based pharmaceutical company, has received USFDA approval for the Abbreviated New Drug Application or ANDA filed for Penicillamine Capsules, 250 mg. The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia. The product will be launched shortly.

Penicillamine Capsules are effective in treatment of Wilson's disease and in patients with severe rheumatoid arthritis. Currently, Granules has a total of 35 ANDA approvals from the USFDA, which includes 2 tentative approvals. Penicillamine Capsules had US sales of $67 million in the previous year.

Granules India manufactures finished dosages or FDs, Pharmaceutical Formulation Intermediates or PFIs as well as Active Pharmaceutical Ingredients or APIs. For the Sep-20 quarter, Granules had reported 71% spurt in net profit at Rs.164 crore on the back of 22.7% growth in total sales revenues to Rs.858 crore in the same period.

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