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Lupin Gets US FDA Form-483 With Seven Observations at the Goa Unit

Synopsis:


Lupin Ltd’s Goa manufacturing facility underwent a US FDA inspection from 10 to 21 Nov 2025 and received a Form-483 citing seven observations; the company will address the findings and respond within the stipulated timeframe.


Source:
 Lupin Press Release (NSE Exchange Fillings) | Published on Nov 21, 2025

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release of Lupin (NSE Exchange Filings), the company's board notified stock exchanges that the manufacturing facility located in Goa, India, was inspected by the U.S. Food and Drug Administration (US FDA) from November 10 through 21, 2025. At the conclusion of the inspection, the US FDA issued a Form 483 with seven observations.

It was confirmed by the company that it will reply to the US FDA with a response within its timeline, and maintain a commitment to compliance with current Good Manufacturing Practice (cGMP) for all of its units.

Also read: Shilpa Medicare Unit IV Receives US FDA Form 483 with Eight Findings

Key Takeaways

  • Inspection period: 10–21 November 2025.

  • Facility: Goa, India manufacturing site.

  • Outcome: Form 483 with seven observations issued by US FDA.

  • Company commitment: To address observations and respond within required timeframe.

  • CGMP standards reaffirmed.

Also read: Tata Chemicals Approves ₹910 Crore Plant Expansions at Mithapur & Cuddalore

LUPIN LIMITED

Trade

1992.7-36.70 (-1.80 %)

Updated - 24 November 2025
2012.20day high
DAY HIGH
1987.30day low
DAY LOW
113642
VOLUME (BSE)

Summary Of Inspection Elements

The following table summarises the elements disclosed after the inspection:

Category

Details

Facility inspected

Lupin manufacturing unit, Goa

Inspection authority

U.S. Food and Drug Administration

Inspection dates

10–21 November 2025

Final outcome

Form-483 issued

Number of observations

Seven

Next step

Company to submit written response

Regulatory basis for disclosure

SEBI Listing Regulations, Regulation 30

Background On Form 483

A Form 483 is issued at the end of an FDA inspection when the investigators observe conditions that may represent violations of the Food, Drug, and Cosmetic Act and associated regulations.

Implications For Manufacturing

Discovery made during an inspection at manufacturing site for Lupin has ramifications for its regulatory and operational status. Since the Goa location is part of Lupin’s broader supply chain, the seven findings may require corrective action, internal audits and possibly follow up inspections. Historically, Lupin has had issues flagged at their Goa facility during prior inspections when the process was conducted by the FDA.

Corporate Disclosure And Market Context

Lupin made the disclosure pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, which requires companies to report on a timely basis events that will impact the operations or performance of the company. The disclosure refers to the inspection period and finding, as well as the company's plan to respond. 

While disclosures like this related to regulation are typical in the pharmaceutical industry, it further emphasizes the regulatory linkages between Indian manufacturing companies and those in the US.

Share Price Update

Lupin share price stands at ₹2,033.90 per share on the BSE as of 21 Nov 2025 at 15:30 PM IST, up by 2.94%.

Published Date : 24 Nov 2025

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