On January 18, 2025, Gland Pharma Limited announced the successful conclusion of the US FDA inspection conducted at its Pashamylaram Facility in Hyderabad. This inspection, which took place between July 25 and August 02, 2024, was focused on the Good Manufacturing Practices (GMP) standards, ensuring that the company’s pharmaceutical operations align with global quality expectations. Following the inspection, the company has officially received the Establishment Inspection Report (EIR) from the US FDA, confirming the closure of the inspection process.

This marks a significant achievement for Gland Pharma, as the inspection is a crucial part of ensuring compliance with international quality standards, essential for continued exports to regulated markets, particularly the US. The EIR from the US FDA indicates that no further action is required from the company, affirming the facility's commitment to high manufacturing standards.

Importance of GMP Compliance for Global Pharma Operations

The closure of the US FDA inspection is an essential milestone for Gland Pharma as it strengthens its position in the global pharmaceutical market. The GMP compliance ensures that the products manufactured at the Pashamylaram facility adhere to the highest industry standards, ensuring safety, efficacy, and quality for consumers worldwide. With the US FDA’s approval, Gland Pharma can continue to expand its international presence, particularly in the US market, which is one of the largest pharmaceutical markets globally.

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