Lupin Gets Zero USFDA Observations for Nagpur Plant

Published On 2026-02-15 06:00 GMT | Update On 2026-02-15 06:01 GMT

Mumbai: Lupin Limited has announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at its Nagpur manufacturing facility, with the audit concluding without any observations.

The inspection outcome marks a significant compliance milestone for the company, as the USFDA closed the audit without issuing a Form 483. The Nagpur facility, Lupin’s newest manufacturing site, manufactures oral solid dosage formulations.

A clean inspection outcome from the US health regulator reinforces Lupin’s regulatory compliance standards and strengthens its manufacturing footprint for supplies to the US market, one of its key geographies.

Also Read: Lupin Settles Mirabegron Patent Dispute With Astellas for USD 90 Million, Clears US Sales

Lupin is an innovation-led transnational pharmaceutical company engaged in the development and manufacturing of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) globally. The company has a strong presence across therapeutic segments including Cardiovascular, Diabetology, Asthma, Paediatric, CNS, GI, Anti-Infective, and NSAIDs, and holds a global leadership position in the Anti-TB segment.

The company continues to focus on strengthening quality systems and maintaining high regulatory standards across its global manufacturing network.

Also Read: Pharma Stalwarts Join Hands to Launch the Story of Desh Bandhu Gupta, Founder of Lupin

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sheeba farhat

Sheeba Farhat Joined Medical Dialogues in 2018 to report on the latest Education news. A Graduate of the University of Delhi, she specializes in covering stories related to Medical Education updates. For inquiries or further information, you can reach her at editorial@medicaldialogues.in.

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Lupin Gets Zero USFDA Observations for Nagpur Plant

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