USFDA issues five observations for Dr Reddy API plant

The audit of API manufacturing plant of Dr Reddy's Laboratories at Srikakulam (Andhra Pradesh) by US Food & Drug Administration (USFDA) got completed on January 28, 2020.  

USFDA has issued Form 483 with five observations. The company would address the said observations comprehensively within the stipulated timeline.

Last month, the company had launched Sodium Nitroprusside Injection, 50 mg/2 ml (25 mg/ml) Single-Dose Vial (SDVs), the therapeutic generic equivalent of Nitropress (a trademark of Hospira, Inc.) Injection, 50 mg/2ml vial, approved by USFDA.

For the recently concluded quarter of December 2019, its consolidated revenue came in at Rs 4,397.1 crore as against Rs 3,864.6 crore in the corresponding quarter last year, registering 13.8 per cent YoY increase. EBITDA for the quarter fell by 135.9 per cent YoY to Rs -288.69 crore as against Rs 804.6 crore in the corresponding quarter last year, with a corresponding margin contraction of 2,739 bps. EBITDA margin for the quarter stood at -6.6 per cent. PAT for the quarter came in at Rs -538.4 crore as against Rs 500.3 crore in the corresponding quarter last year, with YoY decline of 207.6 per cent.

On Wednesday, the stock of Dr. Reddy’s Lab opened at Rs 3,180. In the early morning session, it dipped by 2.8 per cent to Rs 3,101 from its previous close of Rs 3,188.80.