Unichem Labs surges 15% on ANDA nod from USFDA for Aripiprazole tablets

Shares of Unichem Laboratories surged 15 per cent to Rs 257 on the BSE in Friday’s intra-day trade after the company announced that it has received ANDA approval for its Aripiprazole tablets USP from the United States Food and Drug Administration (USFDA).

Aripiprazole tablets are indicated for Schizophrenia and Irritability associated with Autistic Disorder. The product will be commercialized from Unichem’s Ghaziabad Plant, the company said.

“The company has received ANDA approval for its Aripiprazole tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Abilify tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Otsuka Pharmaceutical Company,” Unichem Labs said in a press release.

At 11:26 am; the stock was trading 14 per cent higher at Rs 255.50 on the BSE, as compared to 0.09 per cent gain in the S&P BSE Sensex. A combined 784,000 shares had changed hands on the counter on the NSE and BSE.

The stock has recovered 30 per cent from its 52-week low of Rs 197.50 hit on November 22, 2021. It had hit a 52-week high of Rs 374.90 on May 21, 2021.

On November 26, 2021, Unichem Labs said that ICRA, the credit rating agency has reaffirmed the long-term rating on the Rs 176 crore bank facilities of the Company to [ICRA] A (pronounced ICRA A). The outlook on the long term rating has been revised to negative from stable. This rating indicates to have adequate degree of safety regarding servicing of financial obligations. Such instruments carry low credit risk, the company said.

The revision in outlook to Negative factors in the pressure on Unichem Labs margins in the current fiscal as evident from the sharp dip in profitability levels in H1 FY2022 due to pricing pressures in its key export market (US) leading to net losses on a consolidated basis. The losses at the standalone level remains higher, given the high fixed cost manufacturing base compared to its subsidiaries, ICRA said in rationale.

ICRA also notes that Unichem’s appeal against the order of the European Commission imposing a fine of € 13.9 million on the company and its UK subsidiary, was rejected by the General Court of EU in FY2019 and the aforesaid fine was confirmed. Although the company has filed for an appeal before the EU Court of Justice, an unfavourable outcome would impact its financial profile, ICRA said.

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