Granules India up 5% on USFDA approval for generic Aleve PM tablets

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Shares of Granules India gained 5 per cent at Rs 377 on the BSE on Friday after US health regulator USFDA gave its approval for Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/25 mg (OTC).

The company today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/25 mg (OTC), generic equivalent of Aleve PM Tablets, 220 mg/25 mg, of Bayer HealthCare LLC.

Naproxen Sodium and Diphenhydramine Hydrochloride Tablets are used for relief of occasional sleeplessness associated with minor aches and pains.

Granules now has a total of 31 ANDA approvals from US FDA (29 Final approvals and 2 tentative approvals). The Company produces Finished Dosages (FDs}, Pharmaceutical Formulation intermediates (PFls) and Active Pharmaceutical Ingredients (APIs).

Meanwhile, the pharmaceutical company's stock hit a record high of Rs 395, after rallying 10 per cent in the opening deals on report that that global private equity firms Blackstone, KKR and Bain Capital have expressed interest in acquiring a controlling stake in the company.

The BSE has sought clarification from the company on the said report.

The company said the promoters released 12.95 per cent pledged shares during the April-June quarter; 3.64 per cent of the total shareholder’s equity remains currently pledged.

At 12:17 pm the stock was trading 4.4 per cent higher at Rs 377 on the BSE, against 1.7 per cent rise in the S&P BSE Sensex. A combined around 6.2 million shares have changed hands on the counter on the NSE and BSE, so far.

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