Sun Pharma response to import ban inadequate - FDA
REUTERS - Generic drugmaker Sun Pharmaceutical Industries Ltd's (SUN.NS) response to an import ban on one of its plants lacked "sufficient corrective actions," the U.S. Food and Drug Administration said in a warning letter published on Tuesday.
The FDA banned imports from Sun Pharma's Karkhadi plant in Gujarat in March, but the reason for the ban was not clear at that time.
In the warning letter dated May 7 and posted on the FDA website on Tuesday, the regulator said Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience.
"Your firm frequently performs 'unofficial testing' of samples, disregards the results, and reports results from additional tests," the FDA said in the letter addressed to Sun Pharma CEO Subramanian Kalyanasundaram. (link.reuters.com/pyx49v)
A Sun Pharma spokesman told Reuters on Tuesday that the warning letter shows that the U.S. FDA does not agree with the company's response.
The Karkhadi plant, which makes the antibiotic cephalosporin, is one of Sun Pharma's 25 manufacturing plants.
Sun Pharma, which is planning to buy its struggling rival Ranbaxy Laboratories Ltd (RANB.NS) for $3.2 billion, had said in March that the import ban would have negligible financial impact.
The FDA has unleashed a wave of restrictions, warnings and bans on Indian generic drug firms over the past one year, citing serious manufacturing and quality control problems.
(Reporting by Esha Dey in Bangalore and Zeba Siddiqui in Mumbai; Editing by Sriraj Kalluvila)
- Tweet this
- Share this
- Digg this
DAVOS, Switzerland - Central banks have done their best to rescue the world economy by printing money and politicians must now act fast to enact structural reforms and pro-investment policies to boost growth, central bankers said on Saturday.
Trending On Reuters
U.S. President Barack Obama watched a dazzling parade of India's military might and cultural diversity on Monday, the second day of a visit trumpeted as a chance to establish a robust strategic partnership between the world's two largest democracies. Full Article
Indian economic growth forecasts pegged back, despite rate cuts: Reuters Poll. Full Article