Drugmaker putting together a response to address the US FDA’s observations; analysts are unsure whether the observations made by the regulator would invite stringent action
New Delhi : The US Food and Drug Administration, following an inspection at Lupin Ltd’s Goa facility last week, has observed that the unit has been found not adhering to standard operating procedures, the company’s spokesperson said.
“The observations are on aspects such as inadequacy and adherence to SOPs (standard operating procedures),” the statement said. “We are in the midst of putting together a response to address the US FDA’s observations.” The company did not specify the nature or scope of all the nine observations made by the US regulator. Following the news, shares of Lupin had tanked over 7% to settle at Rs 1726.60 on the Bombay Stock Exchange.
As on date, the Goa manufacturing plant has filed more than 115 abbreviated new drug applications in the US market, according to information on the company’s website. Lupin has also filed for ANDAs for markets like the EU, Japan and Brazil from the facility.
“My guess is the Goa unit contributes 40-50% of the company’s annual revenue from the US, before GAVIS (Pharmaceuticals LLC’s acquisition),” an analyst with a domestic brokerage said.
Analysts are unsure whether the observations made by the regulator would invite stringent action. “I don’t think it is serious because there are no data integrity issues,” an analyst said. Another analyst said it is unclear whether the observations have been classified as voluntary action indicated or official action indicated.
Inspections classified as voluntary action indicated are typically technical violations of the US Federal Food, Drug, and Cosmetic Act, while those requiring official action warrant regulatory action to address the lack of compliance, according to information on the website of the US FDA. Last week’s inspection by the US FDA follows a Form 483 issued by the regulator last year, in which nine observations were cited.
The company’s Managing Director Nilesh Gupta had then said the nature of the observations was