Unichem Laboratories receives 4 observation from USFDA

Specialty pharmaceutical company, Unichem Laboratories informed the bourses that United States Food and Drug Administration (USFDA) has conducted a routine GMP surveillance at company’s Goa formulation facility. The company had submitted ANDAs from this facility.

Post inspection of this facility from July 22 to July 31, 2019, the USFDA has issued four observations, of which none are repeat observations and are mostly procedural in nature, said the company in a press releases. The company said that it will provide the responses and corrective action plan within the next 15 working days to address the USFDA observations.

With response to this development, the stock of Unichem Laboratories was trading in the negative terrain. The stock which opened at Rs. 166.35 per share as against previous close of Rs. 167.55 and dipped nearly 1.3 per cent to touch an intra-day low of Rs. 165.45 apiece.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. The company is involved in producing a basket of pharmaceutical formulations such as branded generics as well as generics in India and several other markets across the world.