Lupin Ltd. announced on Saturday that the company received four observations from the US Food and Drug Administration for its biotech facility in Pune.
The US FDA conducted a product-specific pre-approval inspection at the company’s Pune biotech facility from Sept. 8 to Sept. 19, according to an exchange filing.
At the conclusion of the inspection, the company received four observations. The company will address the observations and respond to the US FDA within the stipulated timeframe.
“We are committed to be compliant with CGMP quality standards across all our facilities,” the company said.
Earlier on Sept. 18, Lupin received approval from the US FDA for its Abbreviated New Drug Application for Lenalidomide Capsules within the range of 2.5 mg to 25 mg.
