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USFDA concludes pre approval inspection at Lupin’s Somerset manufacturing facility

20 May 2024 Evaluate

The US Food and Drug Administration (USFDA) has concluded a Pre Approval Inspection at Lupin’s Somerset, New Jersey manufacturing facility. The inspection was conducted from May 7, 2024 to May 17, 2024, and closed with an issuance of a Form-483 with six observations. The company is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


Lupin Share Price

2328.60 4.35 (0.19%)
20-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1668.00
Dr. Reddys Lab 1232.25
Cipla 1228.90
Zydus Lifesciences 936.35
Lupin 2328.60
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