Latest news with #AngiotensinII
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Business Standard
5 days ago
- Business
- Business Standard
Gland Pharma jumps 3% in trade; here's what is boosting investor interest
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. 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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Business Standard
04-06-2025
- Business
- Business Standard
Gland Pharma share rises 2% in trade on Wednesday, June 4; here's why
Gland Pharma share price: Pharmaceutical company Gland Pharma shares increased as much as 1.58 per cent to hit an intraday high of 1,619 per share on Wednesday, June 4, 2025. At 11:10 AM, Gland Pharma shares continued to trade near day's high, up 1.33 per cent at 1615 per share. Why did Gland Pharma share price rise? Gland Pharma shares rose after it secured United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL. 'Gland Pharma Limited (Gland or Company), a generic injectable & ophthalmicfocused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Angiotensin II Acetate Injection 2.5 mg/mL,' Gland Pharma said, in a press release. 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. 'Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity,' the company claimed. The product had US sales of approximately $58 million for the twelve months ending March 2025, according to IQVIA. Gland Pharma Q4 results Gland Pharma reported a 3 per cent year-on-year (YoY) decline in its consolidated net profit to ₹186.5 crore for the fourth quarter ended March 2025 (Q4FY25), compared to ₹192.4 crore in the same period last year. Revenue from operations fell 7 per cent YoY to ₹1,424.9 crore from ₹1,537.5 crore. The company's Ebitda stood at ₹347.5 crore, marginally down from ₹358.7 crore a year ago. However, the Ebitda margin improved to 24 per cent in Q4FY25, compared to 23 per cent in the corresponding quarter last year. Research and development (R&D) expenses during the quarter were ₹50.3 crore, accounting for 4.9 per cent of revenue. For the full financial year FY25, R&D expenses stood at ₹192.2 crore, or 4.7 per cent of annual revenue. Gland Pharma dividend About Gland Pharma Founded in 1978 in Hyderabad, Gland Pharma has evolved from a contract manufacturer of small-volume liquid parenterals to one of the largest injectable-focused pharmaceutical companies globally. Operating predominantly under a B2B model, it has a presence in over 60 countries, including the US, Europe, Canada, Australia, and India. The company's portfolio spans a wide range of sterile injectables such as vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, as well as oncology and ophthalmic products. Notably, it pioneered Heparin technology in India.
