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The FDA had audited two of Lupin’s facilities—the Lupin Bioresearch Center in Pune and its manufacturing facility at Pithampur near Indore. Photo: Ramesh Pathania/Mint
The FDA had audited two of Lupin’s facilities—the Lupin Bioresearch Center in Pune and its manufacturing facility at Pithampur near Indore. Photo: Ramesh Pathania/Mint

Lupin says FDA raises concerns over Pithampur plant

The FDA issued the company a so-called Form 483, listing six observations on the manufacturing processes

New Delhi: The US Food and Drug Administration (FDA) raised concerns over production processes at drugmaker Lupin Ltd’s Pithampur facility following an inspection in January, the company said on Monday.

The FDA had audited two of Lupin’s facilities—the Lupin Bioresearch Center, Pune (LBC) and its manufacturing facility at Pithampur near Indore—in November 2014 and then in January 2015.

After the Pithampur audit, the FDA issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, a statement issued by the drugmaker said.

In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency’s standard production requirements.

The Lupin stock ended 2.71% down at 1,645.10 on the BSE on Monday, while the BSE healthcare index fell 0.83% to 977.35 points and the benchmark Sensex fell 0.88% to close at 28,975.11 points.

Industry experts maintain a neutral rating on the company’s stock.

“Both audits were completed successfully with the Pune facility not receiving any observations and the Indore facility receiving six observations (483s). Since then, the Indore facility has received one ANDA approval and two site-transfer approvals. While currently, the details of the observations are not known, (though should not be serious given that the company has got approvals after the observation), hence we are not changing our estimates, though the material impact of the damage should not be high," said Sarabjit Kour Nangra, vice-president, (research - pharma) at Angel Broking Ltd.

ANDA is short for abbreviated new drug application.

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