Lupin’s Nagpur Injectable Facility Clears U.S. FDA Inspection with Zero Observations

On June 14, 2024, Lupin Limited, a leading global pharmaceutical company, announced in a stock exchange filing that its Injectable facility located in Nagpur, India, underwent a thorough inspection by the United States Food and Drug Administration (U.S. FDA). The inspection, conducted from June 10 to June 13, 2024, concluded with a favourable outcome as zero 483 observations.

Nilesh Gupta, Managing Director of Lupin, expressed satisfaction with the inspection results, stating, “We are pleased to have a successful outcome of the U.S. FDA inspection at our Nagpur injectable facility with zero observations. This reflects our dedication to upholding the highest quality and compliance standards across our facilities.”

This accomplishment underscores Lupin’s commitment to maintaining high quality and compliance standards in its manufacturing processes.

The facility in Nagpur plays a critical role in Lupin’s operations, particularly in the production of injectable pharmaceutical products. The successful inspection without any observations reflects Lupin’s stringent quality management practices and adherence to regulatory requirements set by the U.S. FDA. Such regulatory approvals are crucial for pharmaceutical companies like Lupin to ensure the integrity, safety, and efficacy of their products in the global market.

Lupin continues to focus on enhancing its manufacturing capabilities and maintaining regulatory compliance across its facilities worldwide. The positive outcome of this inspection further strengthens Lupin’s reputation as a reliable provider of high-quality pharmaceuticals and underscores its commitment to meeting stringent regulatory standards.

Earlier this month, the company announced that it had successfully executed the Business Transfer Agreement (BTA) with Lupin Life Sciences Limited (LLSL). According to the terms of the agreement, the carve-out of the trade generics business will take effect from July 1, 2024.

About Lupin Ltd

Lupin is a Mumbai-based pharmaceutical company known for its innovation across global markets. It specialises in developing and marketing a diverse portfolio of branded and generic formulations, biotechnology products, and APIs. Lupin operates in over 100 markets, spanning India, the USA, South Africa, Latin America (LATAM), Asia Pacific (APAC), the Middle East and Europe.

On June 14, 2024, the share price of Lupin Ltd opened at ₹1,614.00, touching the day’s high at ₹1,615.00, as of 12:18 PM on the NSE.

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