Lupin’s Pune
US FDA flags four observations at Lupin’s Pune biotech facility
The company said it will address the observations and respond to the FDA within the stipulated timeframe, reaffirming its commitment to current Good Manufacturing Practices (cGMP) quality standards across all its facilities.
US FDA flags four observations at Lupin’s Pune biotech facility. Lupin has received four observations from the US Food and Drug Administration (FDA) following a product-specific pre-approval inspection at its biotech facility in Pune.
The inspection was conducted from 8 to 19 September, according to a filing with the stock exchanges.
The company said it will address the observations and respond to the FDA within the stipulated timeframe, reaffirming its commitment to current Good Manufacturing Practices (cGMP) quality standards across all its facilities.
Separately, on September 18, Lupin secured US FDA approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in the 2.5 mg to 25 mg range.
Headquartered in Mumbai, India, Lupin is a global pharmaceutical company with products distributed in over 100 markets.
Its portfolio includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, according to its exchange filing.
