Aurobindo Pharma Limited announced that its subsidiary, Eugia Pharma Specialities Ltd., has received a Warning Letter from the US FDA for its Unit-I facility. This facility is responsible for formulation manufacturing and was previously issued an Official Action Indicated (OAI) status. The company has emphasized that this development is not expected to impact existing supplies to the US market, as Unit I contributes approximately 2% to the group’s overall revenue.
US FDA Warning Letter Issued to Subsidiary
Aurobindo Pharma Limited has disclosed that Unit-I of its subsidiary, Eugia Pharma Specialities Ltd., has received a formal Warning Letter from the United States Food and Drug Administration (US FDA). This follows a previous communication regarding the facility’s Official Action Indicated (OAI) status. The Unit-I facility is engaged in formulation manufacturing.
Impact on Operations and Revenue
The company has assured stakeholders that the issuance of the Warning Letter is not anticipated to cause any disruption to the existing supply chain for products destined for the US markets. It was further stated that Unit I of Eugia Pharma Specialities Ltd. currently contributes approximately ~2% to Aurobindo Pharma’s total group revenue, indicating a limited immediate financial impact.
Commitment to Compliance
Aurobindo Pharma Limited has reiterated its commitment to working collaboratively with the US FDA and is dedicated to continuously improving its compliance standards on an ongoing basis. The company will provide further updates on any significant developments as they occur.
Source: BSE
