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Zydus Lifesciences Gets USFDA EIR for Baddi Plant

Synopsis:


Zydus Lifesciences has received an Establishment Inspection Report from the USFDA for its Baddi unit. The inspection, held between 4–13 August 2025, resulted in a Voluntary Action Indicated (VAI) status, confirming the plant’s compliance with US regulatory standards.


Source:
Zydus Lifesciences Limited Press Release (NSE Exchange Filings) | Published on Oct 29, 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 Limited News Today

As quoted in the press release from Zydus Lifesciences Limited and its official news filing (NSE Exchange Filings), the company confirmed that the United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for its Baddi manufacturing facility in Himachal Pradesh.

The inspection took place from 4 August 2025 to 13 August 2025, after which the facility received a VAI classification, indicating that observations made during the audit do not require further regulatory action. This classification supports Zydus Lifesciences’ ongoing manufacturing and export operations for regulated markets.

Also read: Dr Reddy’s Gets Non-Compliance Notice from Canada

ZYDUS LIFESCIENCES LTD

Trade

987.65-15.25 (-1.52 %)

Updated - 30 October 2025
1006.40day high
DAY HIGH
983.50day low
DAY LOW
260491
VOLUME (BSE)

Key Takeaway

  • Zydus Lifesciences received a USFDA EIR for its Baddi plant.

  • The inspection was conducted from 4 August to 13 August 2025.

  • The facility has been classified as Voluntary Action Indicated (VAI).

USFDA Inspection Details

The inspection at Zydus Lifesciences’ Baddi site was conducted to evaluate compliance with current Good Manufacturing Practices (cGMP). The USFDA issued the Establishment Inspection Report after completing its review of post-inspection responses.

The Voluntary Action Indicated status reflects that the inspection identified only minor observations. Such facilities can continue normal operations without additional USFDA enforcement action.

Zydus Lifesciences operates multiple USFDA-approved plants in India, including facilities in Ahmedabad, Vadodara, and Baddi. The company manufactures finished dosage formulations, active pharmaceutical ingredients, and biologics for domestic and international markets.

Company And Regulatory Overview

Zydus Lifesciences Limited, headquartered in Ahmedabad, Gujarat, is a diversified pharmaceutical organisation engaged in research, manufacturing, and marketing of therapeutic products. Its portfolio covers cardiovascular, gastrointestinal, and oncology segments.

The receipt of the EIR marks a regulatory step for Zydus Lifesciences as it maintains compliance across all its USFDA-inspected facilities. The company continues to serve global markets through quality-compliant manufacturing operations.

Inspection and Facility Snapshot

Parameter

Detail

Company

Zydus Lifesciences Limited

Facility Location

Baddi, Himachal Pradesh, India

Regulatory Authority

United States Food and Drug Administration (USFDA)

Inspection Period

4 August 2025 – 13 August 2025

Report Type

Establishment Inspection Report (EIR)

Classification

Voluntary Action Indicated (VAI)

Focus Area

cGMP Compliance for Pharmaceutical Manufacturing

Operational Context

The Baddi manufacturing facility plays a key role in producing oral solid dosage forms and sterile products for export to the United States. The receipt of the EIR enables Zydus Lifesciences to maintain uninterrupted manufacturing and distribution of approved products.

The company continues to follow stringent quality-control procedures across its network of plants. Its regulatory track record includes multiple facilities cleared by agencies such as the USFDA, EMA, and MHRA.

Zydus Lifesciences Share Price Performance

As of 29 October 2025, 15:30 IST PM, Zydus Lifesciences' share price on the National Stock Exchange (NSE) was ₹1,002.00, up ₹0.75 (0.07 %) from the previous close of ₹1,001.25.

Also Read: Ola Electric Receives CCPA Investigation Report and Hearing Date

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