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Latest news about Gland Pharma

Gland Pharma Sees Rs. 71.82 Crore Block Trade on NSE 5 days ago

A significant block trade of Gland Pharma shares occurred on the National Stock Exchange. The transaction involved 358,221 shares traded at Rs. 2,005.00 per share, totaling approximately Rs. 71.82 crore. This large-scale trade has drawn attention from market observers, potentially indicating shifts in institutional holdings or significant investor interest in the pharmaceutical company.

Brookfield and EQT in Talks to Acquire Gland Pharma from Fosun in Potential ₹25,711 Crore Deal 5 days ago

Gland Pharma's Pashamylaram Facility Secures Danish GMP Compliance Certificate Jul 14, 2025

Gland Pharma's Pashamylaram Facility Secures GMP Compliance Certificate from Danish Medicines Agency Jul 11, 2025

Gland Pharma Receives EIR from US FDA for Visakhapatnam Facility Jun 24, 2025

More news about Gland Pharma

05Jun 25

Gland Pharma's Subsidiary Cenexi Faces Regulatory Scrutiny in France

Gland Pharma's subsidiary Cenexi received 11 observations from France's drug regulator ANSM during a GMP inspection at its Fontenay facility. Cenexi submitted a CAPA plan, accepted by ANSM, with improvements to be implemented over 3-12 months. Gland Pharma assures that manufacturing operations at the facility will not be impacted.

05Jun 25

Gland Pharma's French Facility Receives 11 Observations in ANSM Inspection

Gland Pharma's manufacturing facility in Fontenay, France, owned by Cenexi, underwent an inspection by the French National Agency for Medicines and Health Products Safety (ANSM). The inspection resulted in 11 observations. Despite this, Gland Pharma does not anticipate any disruption to its manufacturing activities at the facility. The company is expected to address these observations to ensure compliance with ANSM's requirements.

04Jun 25

Gland Pharma's Cenexi Facility Faces 11 Observations in ANSM Inspection

Gland Pharma's Cenexi facility in Fontenay, France, underwent an inspection by the French National Agency for the Safety of Medicines and Health Products (ANSM), resulting in 11 observations. Despite these findings, manufacturing operations at the facility continue uninterrupted. The company will likely need to develop and implement corrective action plans to address the observations.

04Jun 25

Gland Pharma Secures FDA Approval for Generic Blood Pressure Drug, Gains Exclusive Market Access

Gland Pharma has received USFDA approval for its generic Angiotensin II Acetate injection, equivalent to GIAPREZA. The drug, used to treat blood pressure in adults with septic shock, has secured First-to-File status with 180-day market exclusivity. The US market for this drug is valued at $58.00 million for the year ending March 2025. The approval has positively impacted Gland Pharma's stock performance.

04Jun 25

Gland Pharma Secures Approval for Angiotensin II Acetate Injection

Gland Pharma has received approval for its Angiotensin II Acetate Injection, a medication used in treating cardiovascular conditions in critical care settings. The product has reported US sales of approximately USD 58.00 million, indicating a significant market opportunity. This approval is expected to strengthen Gland Pharma's position in the pharmaceutical market, particularly in the United States, and potentially enhance its competitive edge in the specialty pharmaceutical segment.

21May 25

Gland Pharma's Q4 Results Show Core Weakness, Cenexi Challenges

Gland Pharma's Q4 net profit decreased 2.60% year-over-year to ₹1.87 billion, while revenue fell 7.29% to ₹14.25 billion. The company recommended a final dividend of ₹18 per equity share. Despite current challenges, including increased competition and Cenexi-related issues, the company projects a 20% earnings CAGR over FY25-27, driven by new product launches and improving Cenexi performance.

20May 25

Gland Pharma: Q4 Profit and Revenue Decline, Misses Estimates

Gland Pharma's Q4 results show a 3.10% decrease in net profit to ₹186.50 crore and a 7.30% decline in revenue to ₹1,424.90 crore year-over-year. Despite these declines, the company improved its EBITDA margin to 24.40%. The company launched four new molecules, filed five ANDAs, and received seven regulatory approvals. The board proposed a final dividend of ₹18.00 per equity share. Cenexi, its European subsidiary, showed 8.00% year-over-year revenue growth.

19May 25

Gland Pharma Anticipates Stable Q4 Performance with Marginal Revenue Growth

Gland Pharma is expected to report a stable Q4 FY performance with 0.90% YoY revenue growth to Rs 1,551.73 crore. EBITDA is projected to increase by 5.54% to Rs 376.14 crore, indicating potential margin expansion. Key drivers include US business momentum, new product launches, and Cenexi recovery. Investors will focus on updates regarding China expansion and the complex product pipeline.

30Apr 25

Gland Pharma Secures USFDA Approval for Glaucoma Treatment, Gains Exclusivity

Gland Pharma has received USFDA approval for its ANDA for latanoprostene bunod ophthalmic solution, 0.024%, bioequivalent to Bausch and Lomb's VYZULTA. The drug is used to reduce intraocular pressure in glaucoma or ocular hypertension patients. As the first-to-file applicant, Gland Pharma has secured 180 days of generic drug exclusivity. The product's US sales were $171.00 million for the 12 months ending February 2025.

30Apr 25

Gland Pharma Secures USFDA Approval for Glaucoma Treatment, Eyeing $171 Million Market

Gland Pharma has received USFDA approval for Latanoprostene Bunod Ophthalmic Solution, 0.024%, a treatment for glaucoma and ocular hypertension. The product is bioequivalent to Bausch and Lomb's VYZULTA and had U.S. sales of $171 million in the year ending February 2023. As the exclusive First-to-File applicant, Gland Pharma is eligible for 180 days of generic drug exclusivity. This approval marks a significant expansion of the company's presence in the U.S. ophthalmic market.

16Apr 25

ICICI Prudential MF Boosts Stake in Gland Pharma Amid Stock Price Volatility

ICICI Prudential Mutual Fund increased its stake in Gland Pharma to 5.08% by acquiring 400,020 shares on April 11, 2025. This led to a 0.80% rise in Gland Pharma's stock price to ₹1,439.00, despite a 10% decline in April due to concerns over potential U.S. pharmaceutical tariffs. The institutional investment signals confidence in the company's long-term prospects amidst industry challenges.

03Apr 25

Gland Pharma Secures FDA Approval for Acetaminophen Injection, Tapping into $55 Million US Market

Gland Pharma received USFDA approval for Acetaminophen Injection (10 mg/mL) in 500mg/50mL and 1000mg/100mL bags. The product is bioequivalent to B. Braun Medical's reference drug. The US market for this injection is valued at $55 million annually. Indicated for pain management in adults and children over 2 years, the product will be launched through a marketing partner.

25Feb 25

Gland Pharma's USFDA Inspection at Visakhapatnam Facility Results in Three Observations

Gland Pharma's Visakhapatnam facility underwent a US FDA inspection from February 19-25, 2025, resulting in three Form 483 observations. The company states these are procedural, not repeated, and unrelated to data integrity. Gland Pharma plans to submit corrective actions within the stipulated timeframe. The company also announced upcoming one-on-one meetings with institutional investors on February 27 and 28, 2025.