USFDA makes three Form 483 observations for Ipca Lab

USFDA had conducted the inspection of Ipca Laboratories’ formulations manufacturing unit situated at Piparia (Silvassa) from August 19-23, 2019.

At the conclusion of the inspection, the USFDA issued a Form 483 with 3 observations.

The company shall be submitting its comprehensive response on these observations to the USFDA within the stipulated time frame.

During FY19, the company had incurred USFDA related remedial cost of Rs. 49 crore and its management has given guidance of Rs. 18 crore for FY20.  

Ipca has emerged as one of India’s top exporters of APIs, with nearly 25 per cent of the revenue coming from APIs. Regulated markets like the USA, Canada, Europe and Australia account for 75 per cent of company’s API exports.

The company's consolidated revenue for Q1FY20 came in at Rs. 1078.19 crore as against Rs. 875.43 crore in the corresponding quarter last year, registering 23.2% yoy increase. The EBITDA for the quarter rose by 67.6% yoy to Rs. 198.72 crore as against Rs. 118.55 crore in the corresponding quarter last year. While, PAT for the quarter came in at Rs. 129.43 crore as against Rs. 68.55 crore in the corresponding quarter last year, recording a yoy increase of 88.8%.

On Monday, the stock of Ipca Laboratories opened at Rs. 950 on the BSE. In the early trading session, it was up by 1.3 per cent to Rs. 970 from previous close of Rs. 957.65.