on Monday said it has filed a detailed response to the Form 483 observations of the US FDA on corrective measures to be implemented after the company’s Vizag facility got adverse observations from US drug regulator on December 8, 2016.
“We wish to state that the company has already filed its detailed response to the Form 483 observations of the USFDA within the time permitted,” Divis said in a statement to stock exchanges.
The company told CNBC-TV18 that it has the capability to transfer active pharmaceutical ingredient (API) manufacturing to different units – in the worst case scenario.
The Vizag API plant or Unit-II was inspected and cleared by UK regulator three months ago, Divis said.
Divi’s Unit-II plant in Visakhapatnam is located at Chippada village, about 35 km north of the port city accounts for two-thirds of the company’s overall business.
United States accounts for 32 percent of overall sales, of which Unit-II alone makes up 15-20 of those sales.
Divis said the company's Unit-I plant located near Hyderabad - has cleared UK regulator audit - a month ago.
Divi’s is engaged in the manufacturing of generic active pharmaceutical ingredients or the key raw materials that go into the manufacture of formulation drugs, custom synthesis of active ingredients for innovator companies, other speciality chemicals and nutraceuticals.
The US drug regulator typically conveys its concerns on manufacturing practices through Form 483 . Companies that receive US FDA observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter or in some cases an import alert may be issued.
USFDA inspected the Unit-2 plant from November 29 to December 6 and issued a Form 483 with five observations pertaining to breaches in data integrity, improper controls and violations of current good manufacturing practices (cGMP).
Analysts who tracked the company said that the nature of observations are negative and may have the potential to escalate into further regulatory action if not resolved over time. With details and the nature of the USFDA observations coming out in open the company has lost over a fourth of its market value.
Shares of Divis dropped 0.45% and were trading at Rs.734.75 on BSE at 10.45 am, the benchmark Sensex
declined 0.11% to 26,728.59 points.