Gland Pharma Gets USFDA Clearance for Visakhapatnam Facility

25 Jun 2025 , 12:07 PM

Gland Pharma Ltd. said on tuesday that it has completed inspection as the US regulator issued an Establishment Inspection Report (EIR) for their Visakhapatnam facility. The receipt of the EIR marks the formal closure of the US health regulator’s pre-approval inspection, which was conducted between February 19 and February 25, 2025.

The audit was completed for sterile active pharmaceutical ingredients (APIs) and intermediates at the company’s manufacturing site in Visakhapatnam’s Jawaharlal Nehru Pharma City (JNPC).

Earlier in June, Gland Pharma also received USFDA approval for its Angiotensin II Acetate injection, a 2.5 mg/mL formulation used to treat low blood pressure in adults with septic or other distributive shock.

The newly approved product is a generic version of GIAPREZA, originally developed by La Jolla Pharma LLC, and is intended for use in critical care settings. In a separate development, the company’s material subsidiary, Cenexi, received a final inspection report from ANSM, the French drug regulatory authority.

The inspection, conducted from December 9 to December 19, 2024, led to 11 observations concerning Good Manufacturing Practices (GMP) compliance at Cenexi’s Fontenay facility.

Cenexi responded with a comprehensive Corrective and Preventive Action (CAPA) plan, proposing a timeline of three to 12 months for full implementation, depending on the nature of each observation. The French regulator has accepted the action plan, and Gland Pharma clarified that the findings would not impact manufacturing operations at the site.

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