Zydus Lifesciences Limited has received a clean report from the US Food and Drug Administration (USFDA) for its Ahmedabad SEZ-II manufacturing facility. The inspection was completed with zero Form 483 observations, confirming compliance with regulatory standards.
Source: Zydus Lifesciences Limited Press Release (NSE Exchange Filings) | Published on Nov 05, 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 from Zydus Lifesciences Limited (NSE Exchange Filings), the company received a clean inspection report from the US Food and Drug Administration (USFDA) for its Ahmedabad SEZ-II facility.
The inspection concluded without any Form 483 observations, as disclosed in the company’s filing with the stock exchanges. The company stated that the inspection was carried out recently as part of routine regulatory oversight by the USFDA.
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Zydus Lifesciences received a clean USFDA report for the Ahmedabad SEZ-II facility.
The inspection was completed with no Form 483 observations.
The inspection was conducted by the USFDA as part of its standard procedure.
The facility manufactures pharmaceutical products for the US market.
The company disclosed the outcome to the NSE and BSE.
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According to the disclosure filed by Zydus Lifesciences Limited, the USFDA completed an inspection of the company’s Ahmedabad SEZ-II manufacturing site. The inspection ended with a “No Observation” classification, indicating full adherence to current Good Manufacturing Practices (cGMP).
The company has informed both NSE and BSE that the facility was found to be compliant during the inspection. The report did not include any requests for corrective or preventive actions.
The filing also notes that the inspection was a part of the USFDA’s regular schedule for assessing pharmaceutical manufacturing facilities that supply products to the United States market.
Information | Description |
Organisation | Zydus Lifesciences Limited |
Plant Name | Ahmedabad SEZ-II |
Address | Ahmedabad, Gujarat |
Regulatory Authority | United States Food and Drug Administration (USFDA) |
Inspection Results | Clean Report (Zero Form 483) |
Inspection Category | Routine cGMP Compliance Audit |
Source | NSE and BSE Filings |
Zydus Lifesciences has established one of its core manufacturing facilities for regulated markets at Ahmedabad SEZ-II site, which manufactures various pharmaceutical products, including formulations exported to the U.S. and other countries.
The facility operates with full compliance to international quality standards, and the recent inspection by the USFDA and the resulting clean report confirm that it is compliant with all regulatory requirements.
Zydus Lifesciences Limited is a worldwide pharmaceutical organisation based in Ahmedabad, India. It is involved in the research, development, manufacturing, and distribution of a large variety of healthcare products, including generic formulations, biosimilars, and active pharmaceutical ingredients (APIs).
The company has a manufacturing footprint that includes facilities accredited by major health authorities, such as the USFDA, EMA, and WHO. Zydus Lifesciences is listed on the National Stock Exchange (NSE) and the Bombay Stock Exchange (BSE) with the symbol ZYDUSLIFE.
According to the NSE quote page, the Zydus Lifesciences share price was ₹973.40 as of 04 November 2025, 15:30 PM IST. The change shown was -₹7.65 (-0.78%) from the previous close of ₹981.05.
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