Dishman Carbogen Amcis Receives US FDA Approval for Naroda Facility
Dishman Carbogen Amcis Limited has received an Establishment Inspection Report (EIR) from the US FDA for its Naroda facility, signifying successful closure of a recent inspection. The company's facilities in Bavla and Naroda in India, as well as in Switzerland and the Netherlands, maintain their US FDA approvals. This development reinforces the company's commitment to quality standards and regulatory compliance in pharmaceutical manufacturing.

*this image is generated using AI for illustrative purposes only.
Dishman Carbogen Amcis Limited, a prominent pharmaceutical company, has announced a significant milestone in its regulatory compliance efforts. The company has successfully received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Naroda facility, marking the successful closure of a recent inspection.
Inspection Details
The US FDA conducted a thorough inspection of the Naroda facility. The inspection focused on evaluating the facility's adherence to good manufacturing practices and regulatory standards.
Regulatory Approval
The receipt of the EIR signifies that the US FDA has found the responses and corrective actions taken by Dishman Carbogen Amcis to be satisfactory, effectively closing the inspection process. This approval reinforces the company's commitment to maintaining high-quality standards in its pharmaceutical manufacturing operations.
Global Facility Approvals
With this latest development, Dishman Carbogen Amcis Limited continues to maintain a strong regulatory position across its global operations. The company confirmed that its facilities in Bavla and Naroda in India, along with multiple facilities in Switzerland and the Netherlands, all retain their US FDA approvals.
Company Statement
In a disclosure to the stock exchanges, Shrima Dave, Company Secretary of Dishman Carbogen Amcis Limited, stated, "We are pleased to share that today the Company has received intimation about the Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection."
The successful closure of this inspection and the maintenance of FDA approvals across its international facilities underscore Dishman Carbogen Amcis Limited's dedication to quality and regulatory compliance in the pharmaceutical industry. This achievement is likely to bolster the company's position in the global pharmaceutical market and its ability to serve customers in regulated markets, particularly the United States.
Historical Stock Returns for Dishman Carbogen Amcis
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
---|---|---|---|---|---|
-2.90% | +0.82% | +12.65% | +31.52% | +39.99% | +43.81% |