Jubilant Pharmova Subsidiary Jubilant Cadista Receives EIR with VAI Status from USFDA

Drug firm Jubilant Pharmova Ltd announced on Wednesday, March 12, that its subsidiary, Jubilant Cadista Pharmaceuticals Inc., has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for its solid oral formulations facility in Salisbury, Maryland, USA.

USFDA Inspection Successfully Closed

The EIR follows an inspection conducted by the USFDA in January 2025, and with this, the inspection is considered successfully closed. Jubilant Pharmova confirmed the receipt of the USFDA’s communication on March 11, 2025, at 09:27 PM IST.

Despite this positive development, the facility is not expected to manufacture any products, as its manufacturing operations were previously shut down, a decision disclosed by the company on April 18, 2024.

Understanding the VAI Status

The Voluntary Action Indicated (VAI) status is assigned when violations are found during an inspection, but the issues do not warrant further regulatory action from the USFDA. While improvements in Good Manufacturing Practice (GMP) compliance are suggested, they remain voluntary.

Under this classification:

• The facility can continue selling approved drugs.
• The company can receive approvals for new drug applications.

USFDA’s Establishment Inspection Report (EIR) Process

Based on the findings of the January 2025 inspection and the company’s response, the USFDA issues an EIR within 30 days of the inspection. This report reflects the agency’s official determination of the facility’s GMP compliance.

The FDA’s Inspection Classification Database categorises inspections under three classifications:

1. No Action Indicated (NAI) – No significant violations found.
2. Voluntary Action Indicated (VAI) – Issues identified, but no enforcement action required.
3. Official Action Indicated (OAI) – Serious violations requiring regulatory intervention.

The VAI classification signals that while some compliance improvements are advised, Jubilant Cadista’s facility is still eligible for regulatory approvals.

Industry Implications

This development provides regulatory clarity for Jubilant Pharmova, ensuring that its Salisbury facility remains compliant with USFDA standards, despite the prior shutdown of manufacturing operations. The EIR further reinforces Jubilant Cadista’s adherence to GMP regulations, which is critical for maintaining trust in its pharmaceutical products.

Stock Performance 

On March 13, 2025, Jubilant Pharmova share price traded 0.14% lower at ₹864.05 at 10:06 AM (IST). Jubilant Pharmova’s share price reached a 52-week high of ₹1,309.00, and a 52-week low of ₹538.80. As per BSE, the total traded volume for the stock stood at 0.47 lakh shares with a turnover of ₹4.19 crore.

At the current price, Jubilant Pharmova shares are trading at a price-to-earnings (P/E) ratio of 361.53x, based on its trailing 12-month earnings per share (EPS) of ₹2.39, and a price-to-book (P/B) ratio of 6.01, according to exchange data.

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