Concord Gets the Green Light—USFDA Gives Dholka Site a Clean Bill of Health

Image Source: Pharma Industrial India

Concord Biotech Ltd (NSE: CONB.NS) has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility at Dholka, Gujarat, officially closing the recent inspection with a "No Action Indicated" (NAI) status. The outcome confirms that the facility meets all the applicable regulatory norms and does not require any further remediation measures.

1. Inspection Timeline and Outcome

The USFDA conducted a routine inspection of the Dholka facility from April 28 to May 2, 2025.
Closure of the EIR and NAI status shows that the inspection was closed successfully without any Form 483 observations, which is a clear indication of excellence in compliance.

2. Strategic Significance

Dholka serves as a significant manufacturing hub for Concord's fermentation-based APIs, which are exported globally.
A clean USFDA record strengthens the company's regulatory image, facilitates unimpeded exports to America, and maintains its reputation in the biopharma supply chain globally.

3. Company Snapshot

Concord Biotech is an R&D-driven biopharmaceutical company with a business of fermentation-based APIs and formulations.
The company has several plants in India and a growing business in regulated economies like the U.S., Europe, and Japan.

Sources: Economic Times, Concord Biotech