Unichem Labs gets ANDA approval for Baclofen tablets; stock shines

Unichem Laboratories informed the bourses on Friday that it has received abbreviated new drug application (ANDA) approval for its Baclofen tablets, USP, 10 mg and 20 mg from United States Food and Drug Administration (USFDA) to market a generic version of Lioresal  (Baclofen) tablets, 10 mg and 20 mg of Novartis Pharmaceuticals Corp. Post this development, the stock of Unichem Laboratories reacted positively and surged nearly 3.5 per cent on BSE to touch an intraday high of Rs 191 apiece.

Baclofen tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. The product will be commercialised from the company’s Ghaziabad Plant.

Earlier this week, the company had received ANDA approval for its Cyclobenzaprine Hydrochloride tablets USP, 5 mg, 7.5 mg, and 10 mg from USFDA.

In the recently concluded quarter (Q4FY20), the company witnessed nearly 15 per cent YoY fall in consolidated revenue to Rs 320.22 crore. In terms of bottom-line, it posted a net loss of Rs 17.18 crore as against Rs 31.74 crore profits in the corresponding quarter of the previous year.

Unichem Laboratories is an integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics in India and abroad.