India's Dr. Reddy's Laboratories ($RDY) has met a deadline to respond to a U.S. Food and Drug Administration warning letter on three of its plants under the scanner, but the contents are under wraps for now.
"At this point in time we are not making our response to the U.S. FDA public," spokesman Calvin Printer said in an email to FiercePharmaAsia.
In a Dec. 8 notice to the Mumbai stock exchange, Dr. Reddy's said it had responded to the Nov. 26 warning letter on Dec. 7.
The warning letter highlighted a continued back-and-forth between the regulator and the company over observations of poor record keeping and the revelation of a previously undisclosed testing lab.
The warning letter covered plants at Srikakulam and Miryalaguda for API (active pharmaceutical ingredient) manufacture and the Oncology Formulation manufacturing facility at Duvvada, following an inspection in February.
The letter hit shares in the Hyderabad-based firm hard and led analysts to cut sales forecasts for the fiscal year ending March 2017 by $75 million, Bloomberg reported in November.
Dr. Reddy's has not been told to stop manufacturing or shipping products from its three plants named in the letter and the company told Bloomberg it is taking "various actions to raise the bar of our quality management system at an organization-wide level."
- here's the story carried in the Economic Times
- and the notice to the stock exchange