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Zydus’ Ahmedabad oncology injectable plant: USFDA GMP report

Synopsis:


Zydus Lifesciences’ oncology injectable facility at SEZ-1, Matoda, Ahmedabad, underwent a USFDA GMP follow-up inspection from 9-18 June 2025. The inspection yielded two observations, neither of which concerns data integrity. The company will address them swiftly.


Source:
Zydus Lifesciences Press Release (NSE Exchange Filings) | Published on Sept 22, 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.

Zydus Lifesciences news today

As quoted in the press release from Zydus Lifesciences, the United States Food and Drug Administration (USFDA) conducted a GMP follow-up inspection at its oncology injectable site in SEZ-1, near Matoda, Ahmedabad, between 09:00 on 9 June and 17:00 on 18 June 2025. The inspection closed with two observations, both minor. Zydus declared that none of the observations are related to data integrity. The company said it will work closely with the USFDA to resolve the issues swiftly; the development has been disclosed under SEBI Regulation 30.

Also read: Ceigall India Becomes Lowest Bidder for Rs 1,700 Cr BESS Solar Project in MP

ZYDUS LIFESCIENCES LTD

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1036-8.84 (-0.84 %)

Updated - 24 September 2025
1048.40day high
DAY HIGH
1033.45day low
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475206
VOLUME (BSE)

Key takeaways

  • Inspection period: 9-18 June 2025 at SEZ-1, Matoda, Ahmedabad.

  • Two observations were raised, both minor; no issues related to data integrity.

  • Zydus is committed to addressing these observations in an expeditious manner.

Also read: NBCC Secures Rs 117 Cr HUDCO PMC Contracts Across Four Indian Cities

Inspection details and regulatory status

The USFDA’s GMP follow-up inspection at the Ahmedabad oncology injectable site was carried out over ten days. Two observations were made, and the company has clarified that none are related to data integrity.

Market opportunity and economic implications

The oncology injectables market is expanding rapidly, with the United States remaining the largest regulated market for such therapies. A positive USFDA compliance update at Zydus’ Ahmedabad plant ensures continued access to this market, which is critical for oncology medicines. By addressing only minor observations, Zydus secures a pathway to sustain exports, safeguard revenue streams, and strengthen its reputation for quality in global pharmaceutical supply chains.

Response to Zydus Lifesciences share price

Zydus Lifesciences' share price stands at ₹1,037.30 per share on the BSE as of 19 September 2025 at 15:30 PM IST. Trading volumes increased as participants welcomed the absence of data integrity issues in the USFDA inspection. The development was interpreted as a stabilising factor for Zydus’ long-term growth, supporting its oncology portfolio and enhancing confidence in its ability to maintain supply to regulated markets.

Table: USFDA Inspection Snapshot for Zydus’ Ahmedabad Plant

Feature

Details

Facility

Oncology injectable plant, SEZ-1, Matoda, Ahmedabad

Inspection period

9-18 June 2025

Regulatory body

US Food and Drug Administration (USFDA)

Number of observations

Two

Nature of observations

Minor; none related to data integrity

Company response

To address observations expeditiously

Implications for operations and compliance

The inspection-closure with only minor observations and no data integrity issues supports Zydus' compliance posture in oncology manufacturing. The company has indicated readiness to engage with the USFDA to resolve the issues. This maintains its credibility in global regulatory oversight. Effective resolution may help sustain or improve relationships with international customers and regulators.

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