Dabur India stated on Thursday that its domestic business remains unaffected after receiving a warning letter from the US Food and Drug Administration (USFDA) concerning manufacturing deficiencies at its pharmaceutical facility in Silvassa. The company confirmed that the Silvassa plant continues operations while it addresses the regulator's observations.
The USFDA held a teleconference with Dabur on May 13, 2026, during which it recommended withdrawing certain product batches from the US market. Dabur has submitted a revised response to the USFDA and is working closely with the regulator to resolve the issues raised. The company emphasized that the warning letter pertains only to its US operations and does not impact its Indian business.
This development comes amid a challenging environment for FMCG companies facing inflation and supply chain pressures. Dabur’s ability to maintain its Indian operations despite the USFDA warning highlights the resilience of its domestic market presence. The USFDA’s involvement underscores the regulatory scrutiny Indian pharmaceutical exporters face in global markets, especially in the United States.
Dabur’s next update on the resolution of the USFDA observations is awaited, with the company continuing to operate its Silvassa plant and ensuring compliance. The warning letter and subsequent regulatory engagement mark a critical phase for Dabur’s pharmaceutical exports to the US, with implications for product availability and market access.