here's that word again - imminent, page-18

Here's another thing that's sure to get some peoples stress levels boiling over, Reddy's Mexico facility has been given a warning letter.

Firstly I am going to say that this is what happens when there is an issue, it becomes public knowledge, so for me there is no worry about our particular filing, considering that Reddy's have just recently launch 3 new generics in the US also.

I confirmed this morning that there are "No issues at any of the plants related to fonda" with Pete. So this article and my comments are being post for general interest and before anything gets blown out of proportion. My question to Pete was if there were any warning letters or 483 observations issued at any of the plants/3rd party facilities to do with Fonda and the above reply confirmed No Issues.


The article:


Dr Reddy's Mexico Facility Gets US FDA Warning Letter
By Rumman Ahmed and Gurdev Singh Virk

Published June 14, 2011
Dow Jones Newswires

BANGALORE -(Dow Jones)- Dr. Reddy's Laboratories Ltd. (500124.BY, RDY) said Tuesday the U.S. Food and Drug Administration has warned that its Mexico unit has violated manufacturing practice norms, making it the latest Indian generic drug maker to fall foul of the U.S. regulator.

The FDA's warning letter has cited four specific deviations at the facility of the Industrias Quimicas Falcon de Mexico SA de C.V. unit and asked Dr. Reddy's to first determine their cause and then prevent them from recurring.

The regulator warned that it might not approve the sale of drugs that list the Dr. Reddy's unit as the ingredients manufacturer and might also ban entry of products made at the facility into the U.S. till the issues were resolved to its satisfaction.

"Dr. Reddy's looks forward to working collaboratively with the U.S. FDA to resolve the matters contained in the warning letter," the Mumbai and New York-listed company said in a statement.

The Mexico facility, which produces drug ingredients and intermediates, is a part of Dr. Reddy's pharmaceutical services and active ingredients business. The Hyderabad, India-based company had purchased Roche Holding AG's (ROG.VX, RHHBY) Mexico manufacturing unit for $59 million in 2005, and now uses it to supply multinational drug makers based in North America and Europe with the raw materials used to make finished forms of drugs.

The pharmaceutical services and active ingredients business accounted for a little more than a fourth of Dr. Reddy's consolidated sales of INR74.69 billion ($1.68 billion) in the last fiscal year ended March 31. North America contributed 16% of this business segment's sales.

The company got almost three-fourths of its revenue from selling generic drugs globally last year.

A stricter regulatory climate in the U.S. has previously led Dr. Reddy's peers such as Ranbaxy Laboratories Ltd. (500359.BY) and Sun Pharmaceutical Industries Ltd. (524715.BY) into trouble with authorities in the U.S. over issues such as the quality of test data and manufacturing practices at their plants in India and abroad.

The warning letter, dated June 3, gives Dr. Reddy's 15 working days from its receipt to notify the agency in writing of the specific steps that have been taken to address the regulatory issues.

Dr. Reddy's said it will respond to the FDA within the stipulated time frame.

The FDA had inspected the Mexico facility in November 2010 and had issued so-called 483 observations, asking the company to correct the deviations from the regulator's manufacturing practice norms.

The letter said Dr. Reddy's Dec. 1, 2010 response to the 483 observations "lacks sufficient corrective actions."

Bino Pathiparampil, a health-care analyst at brokerage IIFL Capital, said the FDA warning letter is unlikely to have any immediate material impact on the company's business unless the situation escalates and the FDA imposes an import ban.

Ranbaxy Laboratories, India's largest drug maker by sales, has been trying to get the FDA to revoke a similar ban almost three years after being stopped from selling some of its products in the U.S. due to manufacturing problems at two of its India facilities.

The FDA banned Aurobindo Pharma Ltd. (524804.BY) from shipping a class of antibiotics made at one of Indian units into the U.S. in February. Small-sized Claris Lifesciences Ltd. (533288.BY) was also slapped with the so-called import alert last November.



http://www.foxbusiness.com/industries/2011/06/14/dr-reddys-mexico-facility-gets-us-fda-warning-letter/