Cohance Lifesciences Limited, formerly Suven Pharmaceuticals Limited, said on 7 November 2026 that the United States Food and Drug Administration has issued an Establishment Inspection Report classifying its Pashamylaram, Hyderabad plant (FEI No. 1000623515) as Voluntary Action Indicated. Receipt of the report closes the inspection, the company told stock exchanges.

What the Cohance USFDA VAI decision covers

In its exchange filing dated 7 November 2026, Cohance said the update follows an earlier communication of 5 August 2026 about the same Pashamylaram manufacturing facility. The USFDA has now issued the Establishment Inspection Report and classified the outcome as Voluntary Action Indicated, or VAI. “With the receipt of the EIR, the said inspection stands concluded,” the company told the National Stock Exchange and BSE. The filing was signed by Sisir K Mishra, company secretary and compliance officer.

The classification sits in a busy season of US inspections of Indian plants. Recent outcomes have ranged from a clean close, such as Alkem’s Mandva API plant clearing a USFDA audit with zero Form 483 observations, to a VAI close at OneSource Specialty Pharma’s Bengaluru sterile product division.

What did the July-August inspection find?

According to Cohance’s 5 August 2026 intimation, USFDA investigators inspected the Pashamylaram site from 27 July to 5 August 2026. At the close of that visit the company received a Form FDA 483 listing five observations. None of the observations related to data integrity, it said then. Cohance added that it was preparing a comprehensive response, including corrective and preventive actions, and described the observations as addressable.

The November filing does not list the individual observations or say whether every point has already been closed. It reports only that the agency has now issued the EIR with a VAI classification and that the inspection is concluded.

What a VAI classification means for a drug plant

The USFDA assigns every inspected site one of three final classifications. A VAI outcome means investigators found objectionable conditions or practices, but the agency has concluded the facility can correct them voluntarily and will not recommend regulatory or administrative action. It sits between No Action Indicated, the cleanest result, and Official Action Indicated, which can lead to warning letters or import alerts.

That distinction matters because scrutiny of Indian manufacturing remains high. India Ratings and Research recently noted that 17% of USFDA inspections at Indian drug plants ended in Official Action Indicated, the most serious category. Other recent closes include a VAI tag for Dr. Reddy’s Srikakulam unit after a Form 483.

Why the Pashamylaram outcome matters

Cohance describes itself as a global contract development and manufacturing organisation specialising in antibody-drug conjugates, nucleic acid chemistry and small molecules. A concluded USFDA inspection at its Hyderabad-area Pashamylaram site is a compliance signal for customers that use Indian CDMO capacity for regulated markets. Domestic quality rules are also tightening, including a draft Schedule M change that would require zero microbial growth in Grade A sterile areas.

Key takeaways

• On 7 November 2026, Cohance Lifesciences said the USFDA issued an Establishment Inspection Report classifying its Pashamylaram, Hyderabad plant as Voluntary Action Indicated.
• The inspection, held from 27 July to 5 August 2026, had ended with a Form FDA 483 listing five observations, none related to data integrity.
• Receipt of the EIR means the inspection now stands concluded, according to the company’s exchange filing.

FAQ

What did the USFDA decide on Cohance’s Pashamylaram plant?

The USFDA issued an Establishment Inspection Report classifying the Pashamylaram, Hyderabad facility (FEI No. 1000623515) as Voluntary Action Indicated, which Cohance said closes the inspection.

When was the Cohance Pashamylaram facility inspected?

USFDA investigators inspected the site from 27 July to 5 August 2026 and issued a Form FDA 483 with five observations at the close of that visit.

Is a VAI classification a clean inspection result?

VAI is not the cleanest possible outcome, which is No Action Indicated, but it means the agency will not recommend regulatory action and expects the company to correct any observations voluntarily.

Featured image: Plant personnel walk past process vessels at Cohance Lifesciences’ Pashamylaram facility in Telangana. Photo: Cohance Lifesciences

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