Cohance Lifesciences Receives USFDA Warning Letter for Nacharam Facility
Cohance Lifesciences has received a USFDA warning letter for its Nacharam facility following an inspection conducted from August 4-12, 2025. The facility was classified as Official Action Indicated (OAI), and the company disclosed this under SEBI regulations. The financial impact appears minimal, with US revenues from this facility contributing less than 2% of consolidated revenues and EBITDA contribution below 1% in FY2025.

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Cohance Lifesciences Limited has received a warning letter from the US Food and Drug Administration (USFDA) concerning its Nacharam facility. The company disclosed this development through an official communication to stock exchanges under Regulation 30 of the SEBI Listing Regulations.
Regulatory Timeline and Inspection Details
The warning letter follows a USFDA inspection conducted at the company's Finished Dosage Formulations manufacturing facility (FDF Unit-I) located at Nacharam, Hyderabad, from August 4, 2025 to August 12, 2025. The company had previously communicated with stock exchanges regarding this inspection through multiple disclosures dated August 13, 2025, September 18, 2025, and October 26, 2025.
| Parameter: | Details |
|---|---|
| Facility: | Nacharam FDF Unit-I |
| Inspection Period: | August 4-12, 2025 |
| Regulatory Body: | USFDA |
| Action Type: | Warning Letter |
| Status: | Official Action Indicated (OAI) |
Financial Impact Assessment
The company has provided detailed financial clarity regarding the potential impact of this regulatory action. According to the official disclosure, US revenues from the affected Nacharam facility contributed less than 2% of consolidated revenues in FY2025. More significantly, the related EBITDA contribution remained below 1%, indicating minimal material impact on the company's overall financial performance.
| Financial Metric: | Impact |
|---|---|
| US Revenue Contribution: | Less than 2% of consolidated revenues |
| EBITDA Contribution: | Below 1% |
| Material Impact: | No material impact indicated |
Company Response and Commitment
Cohance Lifesciences has expressed its commitment to addressing the concerns raised by the USFDA and stated it will work with the regulatory authority to resolve these issues at the earliest. The company emphasized its dedication to maintaining the highest standards of quality and regulatory compliance across all operations.
The warning letter represents a continuation of the Official Action Indicated (OAI) classification that was previously communicated to the stock exchanges. The company remains focused on ensuring the manufacture and supply of high-quality pharmaceutical products for global markets while working toward regulatory compliance resolution.
Historical Stock Returns for Cohance Lifesciences
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -1.45% | +0.96% | -18.88% | -65.01% | -74.50% | -36.38% |


































