Moneycontrol PRO
Check Credit Score
Check Credit Score
HomeNewsBusiness

Lupin gets 2 USFDA observations for its Goa plant

Lupin's Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore are under USFDA's warning letter since November 2017.

February 09, 2019 / 02:53 PM IST
Lupin | Rakesh Jhunjhunwala increased stake in company to 1.53 percent in September quarter, from 1.47 percent in June quarter; LIC also raised stake to 3.71 percent from 2.7 percent and MFs to 12.58 percent from 11.94 percent. (Image: Reuters)

Lupin | Rakesh Jhunjhunwala increased stake in company to 1.53 percent in September quarter, from 1.47 percent in June quarter; LIC also raised stake to 3.71 percent from 2.7 percent and MFs to 12.58 percent from 11.94 percent. (Image: Reuters)

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Drug maker Lupin on February 9 said it got two observations from US drug regulator for its crucial Goa manufacturing site, which is under warning letter.

The inspection was carried out between January 28 to February 8, 2019.

"The observations are procedural in nature and the company is confident of addressing them satisfactorily," Lupin said in a statement.

At the end of every inspection, the USFDA issues its observations on any deviations from current good manufacturing practices (cGMP) on Form 483. Companies will have to respond with corrective and preventive action plan to these observations with 15 days of the receipt of Form 483.

Lupin's Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore are under USFDA's warning letter since November 2017.

Towards the end of last month Unit 2 plant in Pithampur received six observations from USFDA. Lupin's Managing Director Nilesh Gupta, in company's recent media call earlier this week said the drug maker is in the process of responding to the USFDA's observations on Unit 2.

The US drug regulator, after inspecting the two sites in 2017, and expressed concerns over quality control procedures that include handling of out-of-specification (OOS) results and conducting hold-time studies.

Lupin completed an extensive remediation at both of its plants, and invited the USFDA for re-inspection.

Viswanath Pilla
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Feb 9, 2019 02:52 pm

Discover the latest business news, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!

Advisory Alert: It has come to our attention that certain individuals are representing themselves as affiliates of Moneycontrol and soliciting funds on the false promise of assured returns on their investments. We wish to reiterate that Moneycontrol does not solicit funds from investors and neither does it promise any assured returns. In case you are approached by anyone making such claims, please write to us at grievanceofficer@nw18.com or call on 02268882347