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Gland Pharma shares gained 3.2 per cent in trade on Tuesday, logging an intraday high at ₹1,800 per share on BSE. The stock was in demand after the company received an Establishment Inspection Report (EIR) from the US Food and Drugs Administration (US FDA) for its facility at JNPC, Visakhapatnam.
At 12:12 PM, Gland Pharma share price was trading 2.08 per cent higher at ₹1,780 per share on the BSE. In comparison, the BSE Sensex was up 1.34 per cent at 82,993.55. The company's market capitalisation stood at ₹29,326.64 crore. Its 52-week high was at ₹2,220.95 per share and 52-week low was at ₹1,200 per share.
"This is to inform you that following the Pre-approval inspection (PAI) for Sterile APIs at the Company’s Facility at JNPC, Visakhapatnam between February 19, 2025, and February 25, 2025; the Company has received an Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," the filing read.
EIR is a document generated by the US FDA or other regulatory authorities after they conduct an inspection of a pharmaceutical manufacturing facility.
The EIR serves as an official record of the company’s compliance with Good Manufacturing Practices (GMP), safety protocols, and regulatory requirements. A positive EIR (indicating compliance) shows that the company meets the necessary standards to produce drugs safely and effectively.
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Recently, Gland Pharma secured USFDA approval for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL.
Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Giapreza of La Jolla Pharma LLC, the company revealed.
About Gland Pharma
Gland Pharma is a small-molecule generic injectables-focused company, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets in the rest of the world. Gland Pharma has seven manufacturing facilities in India, comprising four facilities for finished formulations and three API facilities. We are focused on meeting diverse injectables needs with a stable supply of affordable and high-quality products. We have established a portfolio of injectables products across various therapeutic segments and delivery systems and are present in sterile injectables, oncology and ophthalmics with a focus on complex injectable
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