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Latest news about Glenmark Pharmaceuticals

Glenmark Pharma's Monroe Facility Passes USFDA Inspection with Minor Observations 1 day ago Yesterday

Glenmark Pharmaceuticals' Monroe facility underwent a USFDA inspection resulting in five procedural observations with no data integrity concerns. This outcome is viewed positively, suggesting robust quality control and data management practices. The facility is likely to continue operations without significant disruptions, pending resolution of the minor observations.

Glenmark Pharmaceuticals Expands Cancer Treatment Options with Brukinsa Launch in India 10 days ago

Glenmark Pharma Reports Promising Results for Novel Multiple Myeloma Treatment Jun 02, 2025

Glenmark's Multiple Myeloma Drug Shows Promising Results in Early-Stage Trial Jun 02, 2025

Glenmark Pharmaceuticals: ICICI Securities Raises Target Price, Maintains 'Reduce' Rating May 27, 2025

More news about Glenmark Pharmaceuticals

27May 25

Glenmark Pharma Unveils Product Launch Pipeline and FY26 Financial Projections

Glenmark Pharmaceuticals has announced key product launches and financial projections for FY26. The company secured UK approval for Winlevi, plans to launch two oncology products (Tislelizumab and Zanubrutinib) in partnership with BeiGene, and expects to introduce new respiratory products. Glenmark's partner in mainland China anticipates product approval in FY26. The company projects 10-12% revenue growth, 19-20% EBITDA margin, and ₹300-400 crore cash generation for FY26.

26May 25

Glenmark Pharmaceuticals: Q4 Results Miss Estimates, Shares Slump

Glenmark Pharmaceuticals reported Q4 results below market expectations. Revenue increased 6.30% YoY to Rs 3,256.00 crore and EBITDA grew 11.00% to Rs 561.00 crore, both missing Bloomberg estimates. Net profit stood at Rs 4.70 crore, significantly lower than the estimated Rs 344.00 crore. Following the results, the company's shares fell by 3.53%.

23May 25

Glenmark Pharmaceuticals: Q4 Profit Misses Estimates, Declares Dividend

Glenmark Pharmaceuticals reported Q4 FY23 results with a consolidated net profit of ₹4.70 crore, turning profitable from a loss last year but falling short of expectations. Revenue increased by 6.3% to ₹3,256.00 crore, while EBITDA rose 11% to ₹561.00 crore. The company declared a dividend of ₹2.50 per equity share.

09May 25

Glenmark Pharma's Indore Facility Faces USFDA Compliance Challenge

Glenmark Pharmaceuticals' Indore manufacturing facility has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration following a February 2025 inspection. This status suggests potential violations of regulatory standards and may affect new product approvals. Glenmark has committed to addressing the USFDA's concerns and working towards full compliance. The company may face increased scrutiny and need to implement significant operational changes.

06May 25

Glenmark's Subsidiary Secures FDA Fast Track Designation for Novel Multiple Myeloma Treatment

Glenmark Pharmaceuticals' subsidiary, Ichnos Glenmark Innovation (IGI), has received FDA Fast Track Designation for ISB 2001, a novel trispecific antibody therapeutic for relapsed or refractory multiple myeloma. The drug, currently in Phase 1 trials, has shown promising initial results with high overall response rates and a favorable safety profile. This designation could expedite the drug's development and review process, addressing a significant unmet need in multiple myeloma treatment.

05May 25

Glenmark's Subsidiary Secures FDA Fast Track Designation for Multiple Myeloma Drug

Glenmark Pharmaceuticals' subsidiary, Ichnos Glenmark Innovation (IGI), has received Fast Track Designation from the FDA for ISB 2001, a tri-specific antibody therapeutic for relapsed/refractory multiple myeloma. The drug showed promising Phase 1 results and previously received orphan drug designation. This status allows for expedited review and development, potentially leading to earlier approval. Complete results are expected at the 2025 ASCO annual meeting.

30Apr 25

Glenmark Pharma Refutes Connection to Flagged Drugs, Confirms Products as Spurious

Glenmark Pharmaceuticals has issued a strong clarification regarding recent reports about drugs flagged by the Central Drugs Standard Control Organisation (CDSCO). The company states that the products in question are spurious and were not manufactured by Glenmark or its affiliates. Regulatory authorities have confirmed these items as counterfeit. Glenmark is taking steps to counter spurious products, including changes in packaging and strengthening the supply chain.

21Apr 25

Glenmark Pharmaceuticals Witnesses Significant Block Trade on NSE

A significant block trade of 208,684 Glenmark Pharmaceuticals shares occurred on the National Stock Exchange (NSE) at Rs. 1,350.60 per share, totaling Rs. 28.18 crores. The identities of the buyer and seller were not disclosed. This large transaction has drawn market attention, potentially signaling shifts in investor sentiment or portfolio adjustments by major players in the pharmaceutical sector.

17Apr 25

Glenmark Pharmaceuticals: US Arm to Launch $422 Million ADHD Drug in 2025

Glenmark Pharmaceuticals Inc., USA plans to introduce generic versions of Adderall tablets in the US market starting May 2025. The generic drug, available in 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths, aims to address the current shortage of ADHD medication. The Adderall tablets market had annual sales of approximately $421.70 million for the 12-month period ending February 2025. Glenmark's entry is expected to increase accessibility, potentially reduce costs, and help alleviate the shortage of this widely prescribed medication.

16Apr 25

Glenmark Pharmaceuticals Set to Launch Generic Adderall in US Market

Glenmark Pharmaceuticals plans to introduce a generic version of Adderall tablets in the United States through its US subsidiary. The product, available in 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths, is bioequivalent to Teva's Adderall® Tablets. With annual sales of $421.70 million for Adderall® Tablets, Glenmark aims to capitalize on this market opportunity. The company plans to begin distribution in May 2025, potentially alleviating ongoing shortages in the country.

09Apr 25

Glenmark Pharmaceuticals Faces FDA Recall of 39 Products in US Market

The US FDA has initiated a Class-II recall of 39 drugs from Glenmark Pharmaceuticals' US arm due to nearing expiry dates. Most affected products were manufactured at Glenmark's Pithampur plant. The recall, classified in April 2025, led to a 7% drop in Glenmark's stock price. This event poses financial, regulatory, and reputational challenges for the company, highlighting the ongoing scrutiny faced by Indian pharmaceutical firms in international markets.

07Apr 25

Glenmark Pharmaceuticals Announces Key Leadership Changes: Anurag Mantri Appointed as President

Glenmark Pharmaceuticals has appointed Anurag Mantri as President, effective April 7, 2025. Mantri, with over 30 years of management experience, joins from Jindal Stainless Limited. V.S. Mani, current Executive Director & Global CFO, will retire early, stepping down on May 26, 2025. Mantri is expected to assume Mani's roles pending approval from relevant committees and the Board.

01Apr 25

Glenmark Pharma Launches Vancomycin Injection in USA, Plans to Shut Down Swiss Facility

Glenmark Pharmaceuticals has launched Vancomycin Hydrochloride for Injection USP in the USA, a product with annual sales of $39.30 million. Simultaneously, the company is closing its Chemistry, Manufacturing, and Controls (CMC) development and clinical supplies manufacturing facility in La Chaux-de-Fonds, Switzerland.

29Mar 25

Glenmark Pharma to Shut Down Swiss Subsidiary's CMC and Clinical Supplies Operations

Glenmark Pharmaceuticals announced the closure of its Swiss subsidiary IGI Inc.'s Chemistry, Manufacturing, and Controls (CMC) development and clinical supplies manufacturing operations in La Chaux-de-Fonds by July 31, 2025. The facility, valued at Rs. 223.52 million, was used for captive consumption and its closure is not expected to impact the company's turnover. Glenmark plans to shift these operations to Contract Development and Manufacturing Organizations (CDMOs) to meet future clinical program demands. This strategic move is not anticipated to adversely affect Glenmark's consolidated financials.

24Mar 25

USFDA Flags Issues at Glenmark Pharmaceuticals' Indian Manufacturing Facility

The USFDA has identified problems at a Glenmark Pharmaceuticals factory in India, potentially impacting the quality and supply of certain generic medications in the US market. This development could lead to increased regulatory scrutiny, possible delays in new product approvals, and the need for corrective actions by Glenmark. The situation highlights the importance of quality control in pharmaceutical manufacturing and may have broader implications for the generic drug industry.

21Mar 25

Glenmark Pharma Secures ANDA Approval for OTC Olopatadine Eye Drops

Glenmark Pharmaceuticals has received FDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), bioequivalent to Alcon's Pataday® Once Daily Relief. The product enters a market with annual sales of $50.70 million. Glenmark Therapeutics Inc., USA will distribute the eye drops in the United States, strengthening the company's position in the OTC eye care market.

20Mar 25

Glenmark Pharmaceuticals Secures FDA Approval for OTC Olopatadine Ophthalmic Solution

Glenmark Pharmaceuticals' US subsidiary has received FDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), an over-the-counter eye drop solution. The product is bioequivalent to Alcon's Pataday® Once Daily Relief Ophthalmic Solution, which had annual sales of $50.70 million. Glenmark Therapeutics Inc., USA will distribute the product in the US market, expanding the company's OTC ophthalmic portfolio.

20Mar 25

Glenmark Pharma Secures ANDA Approval for OTC Olopatadine Eye Drops, Tapping into $50.70 Million Market

Glenmark Pharmaceuticals' U.S. subsidiary has received FDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC). This eye drop solution is bioequivalent to Alcon's Pataday® Once Daily Relief, which had annual sales of $50.70 million. Glenmark Therapeutics Inc., USA will distribute the product in the United States, strengthening the company's presence in the OTC ophthalmic market.

12Mar 25

Glenmark Pharma Bolsters Cardiometabolic Portfolio with Empagliflozin Launch in India

Glenmark Pharmaceuticals has introduced three new products under its 'Glempa' brand, featuring Empagliflozin and its combinations, aimed at treating type 2 diabetes mellitus and heart failure. The launch includes Glempa (Empagliflozin), Glempa-L (Empagliflozin + Linagliptin), and Glempa-M (Empagliflozin + Metformin). Clinical trials have shown significant benefits in cardiovascular risk reduction, glycemic control, and weight management. The Empagliflozin market in India is valued at ₹642 crore, while the entire SGLT2 inhibitors market stands at ₹2,904 crore.

10Mar 25

Glenmark Therapeutics Enters $555 Million OTC Market with New Polyethylene Glycol Solution

Glenmark Pharmaceuticals' US subsidiary has launched Polyethylene Glycol 3350, Powder for Solution, in a 17 grams per capful dosage. This product enters a market segment with annual sales of approximately $555.7 million, competing with MiraLAX®. The launch aligns with Glenmark's strategy to expand its OTC portfolio and meet market demands in the US pharmaceutical sector.

04Mar 25

Glenmark Pharmaceuticals USA Expands Portfolio with Acetylcysteine Injection Launch

Glenmark Pharmaceuticals Inc., USA has acquired and launched Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials in the U.S. market. The product's market achieved annual sales of approximately $15.2 million for the 12-month period ending January 2025. Glenmark acquired the ANDA from Aspen Pharma USA Inc. This strategic move aims to strengthen Glenmark's position in the U.S. hospital segment.

02Mar 25

Glenmark Pharmaceuticals Initiates Massive Recall of ADHD Medication in US Market

Glenmark Pharmaceuticals has initiated a recall of approximately 1.5 million bottles of Atomoxetine Capsules, a generic ADHD medication, from the US market. The recall, which began on January 29, 2025, affects multiple strengths ranging from 10 mg to 100 mg. The action is due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This large-scale recall raises concerns about quality control processes and may have significant financial implications for the company, including recall costs, potential sales losses, and possible expenses for manufacturing improvements.

27Feb 25

Glenmark Pharmaceuticals Launches Epinephrine Injection in US Market, Targeting $42.7 Million Opportunity

Glenmark Pharmaceuticals' US subsidiary has launched Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial in the US market on February 27, 2025. The product is bioequivalent to BPI Labs' reference drug and enters a market with annual sales of $42.7 million. Glenmark has secured 180 days of Competitive Generic Therapy exclusivity, potentially giving it a significant market advantage.

24Feb 25

Glenmark Pharmaceuticals Settles Antitrust Lawsuits for $7 Million

Glenmark Pharmaceuticals has agreed to pay $7 million to settle antitrust and consumer protection lawsuits filed by Humana, Centene, and Kaiser. The lawsuits alleged anti-competitive agreements related to generic versions of cholesterol-lowering drugs Zetia® and Vytorin®. Glenmark denies all allegations, stating the settlement is not an admission of liability. This settlement follows earlier agreements reached in 2023 with other plaintiff groups.

24Feb 25

Glenmark Pharma Settles Antitrust Lawsuits for $7 Million with Major Healthcare Companies

Glenmark Pharmaceuticals has reached a $7 million settlement with Humana, Centene, and Kaiser to resolve antitrust and consumer protection lawsuits related to cholesterol drugs Zetia® and Vytorin®. The settlement, approximately ₹58.1 crore, concludes long-standing legal disputes consolidated in the Eastern District of Virginia, U.S. Glenmark denies all allegations and maintains that the settlement does not imply admission of liability or illegality. This agreement follows previous settlements with other plaintiff groups in 2023.