This site is intended for Healthcare professionals only.

Lupin gets 3 observations from USFDA for Mandideep plant

Lupin gets 3 observations from USFDA for Mandideep plant

New Delhi : Drug major Lupin said it has received a total of three observations relating to violation of production norms at manufacturing facilities at Mandideep, Madhya Pradesh from the US Food and Drug Administration.

However, the company said the observations were “minor in nature” and would not lead to any disruption of product supply from the location.

“We had an audit at our Mandideep location from February 2 to February 19. There were total of three observations. As the site has both dosage form facility and API facility, two separate form 483s were issued with two observations each,” Lupin said in a regulatory filing.

One of the observations was repeated in both the forms as it is relevant to both operations, it added.

“We believe that these observations are minor in nature and have already addressed these observations. We believe that the outcome of the audit will be voluntary action indicated only and there will be no remediation required,” it said.

The company said it does not “expect any disruption to product supply from Mandideep location. There are no pending applications from the facility.”

The company’s Mandideep facility is engaged in the manufacturing of APIs as well as dosage forms which produces sterile and non-sterile pharmaceutical products and mainly caters to the US and Europe markets. It employs over 1,200 people and was established in 1986.

Reacting to the development, shares of the company today tumbled over 14 per cent to hit one-year low level.

The scrip plummeted by 13.45 per cent to Rs 1,294.05, its 52-week low, on BSE. On NSE, shares of the company tanked 14.38 per cent to hit its one-year low of Rs 1,280.

At present, the company has a market valuation of Rs 62,227.76 crore.

Earlier this month, the company had received nine observations relating to inadequacy and adherence to operating norms for manufacturing plant in Goa from the USFDA.

Source: PTI
0 comment(s) on Lupin gets 3 observations from USFDA for Mandideep plant

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted