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USFDA concludes inspection with two observations at Lupin’s Ankleshwar facility

09 Mar 2026 Evaluate

US Food and Drug Administration (USFDA) has concluded an inspection at Lupin’s manufacturing facility at Ankleshwar, India. The Inspection was conducted from March 02, 2026 to March 07, 2026 and closed with the issuance of a Form-483 with two observations. The company will address the observations and 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.

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Company Name CMP
Sun Pharma. Inds. 1860.00
Dr. Reddys Labs. 1250.00
Cipla 1383.00
Lupin 2060.00
Zydus Lifesciences 1195.20
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