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Ipca Laboratories’ Tarapur API Facility Gets VAI Classification From US FDA

Synopsis:


Ipca Laboratories’ Active Pharmaceutical Ingredients (API) facility at Tarapur (Palghar, Maharashtra) has been classified as Voluntary Action Indicated (VAI) by the US FDA, indicating a minimally acceptable state of CGMP compliance. This follows inspection during 1–5 Dec 2025.


Source:
IPCA Laboratories Press Release (NSE Exchange Fillings) | Published on Feb 07, 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 IPCA Laboratories (NSE Exchange Filings), the company has received the Establishment Inspection Report for its Active Pharmaceutical Ingredients manufacturing facility located at Tarapur in Palghar district, Maharashtra. The inspection was carried out by the United States Food and Drug Administration between 1 December and 5 December 2025.

The inspection outcome classifies the Tarapur facility as Voluntary Action Indicated. This classification signifies that the facility is considered to be in a minimally acceptable state of compliance with current good manufacturing practices. The update was disclosed under the company’s regulatory obligations as per applicable listing regulations.

Also Read: Reliance Consumer Acquires Majority Stake In Australia’s Goodness Group

Ipca Laboratories Ltd

Trade

145235.30 (2.49 %)

Updated - 09 February 2026
1455.00day high
DAY HIGH
1416.00day low
DAY LOW
111733
VOLUME (BSE)

Key Takeaways

  • The US FDA inspected Ipca Laboratories’ Tarapur API facility from 1 to 5 December 2025

  • The Establishment Inspection Report classifies the facility as Voluntary Action Indicated

  • VAI status confirms minimal compliance with current good manufacturing practices

  • The classification does not involve regulatory enforcement action

  • The update relates specifically to the Tarapur API manufacturing unit

What the VAI Classification Indicates

A Voluntary Action Indicated classification is issued when certain observations are noted during an inspection, but these observations do not meet the threshold for regulatory action. Facilities with this status are considered operationally acceptable, provided that identified issues are addressed through routine corrective processes.

For pharmaceutical manufacturers, the outcome indicates that production can continue without interruption, subject to internal compliance measures. The classification also suggests that the facility meets baseline regulatory requirements, even though improvements may be expected as part of standard quality management systems.

Ipca Laboratories operates multiple manufacturing facilities across India and supplies pharmaceutical products to both domestic and international markets. Regulatory inspections form a routine part of oversight for companies with exposure to regulated markets such as the United States.

Regulatory Compliance Context

The Tarapur facility plays a role in Ipca Laboratories’ API manufacturing operations. Inspections by overseas regulators are a standard requirement for facilities supplying regulated markets. The December 2025 inspection and subsequent Establishment Inspection Report form part of this ongoing regulatory process.

The company had earlier informed stock exchanges about the inspection under disclosure requirements. The receipt of the inspection report completes the regulatory update cycle related to this specific inspection event.

Aspect

Detail

Company

Ipca Laboratories Limited

Facility

API Manufacturing Unit, Tarapur

Location

Palghar, Maharashtra

Inspection Period

1–5 December 2025

Regulatory Authority

US FDA

Inspection Outcome

Voluntary Action Indicated

Compliance Status

Minimally acceptable CGMP compliance

Share Price Update

Ipca Laboratories share price stands at ₹1,416.70 per share on the BSE as of 6 February 2026 at 15:30 IST, down by 1.76%. The IPCA share price movement reflects routine market activity on the day following the regulatory update.

Also Read: Power Finance Corporation Acquires Majority Stake in REC Ltd

Published Date : 09 Feb 2026

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