Granules India's Telangana API Facility Receives US FDA Observation Jun 23, 2025
Granules India's API Facility Completes USFDA Inspection with Single Observation Jun 23, 2025
Granules India's API Facility Completes FDA Inspection with One Observation Jun 20, 2025
More news about Granules
20Jun 25
Granules India's API Facility Completes USFDA Inspection with One Observation
Granules India's Active Pharmaceutical Ingredient (API) Unit-I facility in Bonthapally, Telangana, has undergone a United States Food and Drug Administration (USFDA) inspection. The inspection resulted in one Form 483 observation. The company has not disclosed specific details about the observation or their planned response. This regulatory milestone is crucial for maintaining compliance and ensuring product quality and safety in the pharmaceutical industry.
28May 25
Granules India Reports Strong Q4 and FY25 Performance with 21% EBITDA Margin
Granules India's Q4 and FY25 financial results show robust performance. The company maintained a steady EBITDA margin of 21.00% for FY25, within their guidance range. Notably, Granules India's revenue share from North America increased significantly to 79.00% in Q4FY25, up from 70.00% in Q4FY24, indicating successful expansion in this key market. This growth suggests a strategic shift in the company's global operations, potentially leading to higher profit margins and increased exposure to a stable market environment.
28May 25
Granules India: Q4 Results Show Flat Sales, Narrowing Margins
Granules India's Q4 financial results show a modest 1.80% increase in revenue to ₹1,197.50 crore. While EBITDA declined by 1.40% to ₹252.00 crore with a margin of 21.10%, net profit surged by 18.00% to ₹152.00 crore. The company faces a regulatory challenge with a USFDA warning letter for its Gagillapur facility.
11Apr 25
Granules India Completes Strategic Acquisition of Senn Chemicals, Expanding into Peptide Therapeutics and CDMO Services
Granules India Limited has finalized its acquisition of Senn Chemicals AG, a Swiss CDMO specializing in peptide development and manufacturing. The acquisition, announced on April 10, 2025, was executed through Granules' wholly-owned subsidiary, Granules Peptides Private Limited. This strategic move marks Granules' entry into the peptide therapeutics segment and expands its CDMO capabilities. The acquisition enhances Granules' global footprint, particularly in Europe, and adds specialized expertise in peptide synthesis. Granules plans to maintain Senn Chemicals' brand and operations in Switzerland while leveraging the acquisition to accelerate development of peptide-based APIs, including GLP-1 receptor agonists.
26Mar 25
Granules India Streamlines US Operations with Internal Restructuring Plan
Granules India Ltd. has approved an internal restructuring plan for its US subsidiaries. Granules USA, Inc. will transfer its business and assets to Granules Pharmaceutical, Inc. The restructuring aims to simplify organizational structure, consolidate operations, and improve efficiency without changing ultimate ownership or nature of US operations. Additionally, Dr. P.N. Baskaran has been appointed as President - Head API Manufacturing & Operations, effective April 02, 2025.
25Mar 25
Granules India Streamlines US Operations and Appoints New Head of API Manufacturing
Granules India announces internal restructuring of US subsidiaries, with Granules USA transferring assets to Granules Pharmaceutical to streamline operations. Dr. P.N. Baskaran appointed as President – Head of API Manufacturing and Operations, effective April 2, 2025, bringing 30 years of industry experience.
25Mar 25
Granules India Streamlines US Operations with Internal Restructuring
Granules India has approved an internal restructuring plan for its US operations. The plan involves transferring assets from Granules USA, Inc. to Granules Pharmaceutical, Inc., both wholly-owned subsidiaries. This move aims to simplify the organizational structure, reduce legal entities, and enhance operational efficiency in the US market. The restructuring will not change the ultimate ownership or nature of business operations in the US.
18Mar 25
Granules India Streamlines Operations: Dissolves European Subsidiary
Granules India Limited has announced the voluntary dissolution of its wholly-owned foreign subsidiary, Granules Europe Limited, located in Bath, UK, effective March 18, 2025. The dissolution is part of a strategic change in the company's business model. The financial impact is minimal, with the subsidiary reporting nil external revenue and a net worth of Rs. (10.49) million as of March 31, 2024. This move suggests a realignment of Granules India's international operations to better suit current business strategies and market conditions.
10Mar 25
USFDA Flags Storage and Equipment Issues at Granules India's Telangana Plant
The U.S. Food and Drug Administration (USFDA) has raised concerns about Granules India's manufacturing facility in Telangana, citing deficiencies in storage facilities and equipment maintenance. This regulatory action could potentially impact the company's operations and compliance status with U.S. drug regulations. The incident highlights the strict regulatory environment for pharmaceutical companies operating in international markets, particularly the U.S. Granules India has not yet issued a public response to these observations.
09Mar 25
Granules India Faces USFDA Warning for Manufacturing Violations at Telangana Plant
The USFDA has issued a warning letter to Granules India citing significant violations of Current Good Manufacturing Practice (CGMP) regulations at its Telangana formulations plant. Key issues include inadequate equipment maintenance, facility contamination, and improper record-keeping. The company has 15 working days to respond with a corrective action plan. Failure to address these issues could lead to delays in new drug approvals and impact the company's market position.
05Mar 25
Granules India Shares Tumble 3% Following FDA Warning Letter for Key Facility
Granules India's shares declined 3% after the FDA issued a warning letter for its Gagillapur unit, which contributes 70% of the company's revenue. The letter highlighted data integrity concerns, quality control issues, and contamination risks. This regulatory action may lead to delayed product approvals, significant remediation costs, and potential impact on market perception. The company now faces the challenge of addressing these concerns to minimize operational disruptions and maintain its market position.
03Mar 25
LIC Boosts Stake in Granules India to Over 5%, Shares Jump
Life Insurance Corporation of India (LIC) has increased its stake in Granules India Ltd. from 4.26% to 5.02% by purchasing 17.83 lakh additional shares between January 1 and March 3. This move led to a nearly 3% jump in Granules India's share price, reflecting positive market sentiment. The increased stake by LIC may enhance Granules India's credibility, potentially contribute to stock stability, and attract more investor interest.
28Feb 25
Granules India Receives FDA Warning Letter for Gagillapur Facility, Operations Continue Unaffected
Granules India has received an FDA warning letter for its Gagillapur facility following an August 2024 inspection. The company continues manufacturing and distribution of existing products but acknowledges potential delays in new product approvals. Granules has implemented a comprehensive remediation plan, engaged consulting firms, and is providing regular updates to the FDA. The company maintains its growth strategy remains robust, focusing on new launches, capacity expansion, and pipeline development in various markets.
27Feb 25
Granules India Receives FDA Warning Letter for Gagillapur Facility, Implements Comprehensive Remediation Plan
Granules India Limited has received a Warning Letter from the U.S. FDA for its Gagillapur facility following an August 2024 inspection. The facility remains under Official Action Indicated status, potentially impacting new product approvals. Existing product manufacturing and distribution continue unaffected. The company is implementing a comprehensive remediation plan, including corrective actions, engagement of consulting firms, and continuous product testing. Granules India maintains a positive growth outlook, citing various growth drivers and expressing confidence in resolving the issues within a reasonable timeframe.
24Feb 25
Granules India Set to Acquire Senn Chemicals AG in ₹1.93 Billion Deal
Granules India has announced the acquisition of a 100% equity stake in Senn Chemicals AG for ₹1.93 billion ($23.2 million USD). This strategic move aims to enhance Granules' manufacturing capabilities, expand market presence, and potentially integrate new technologies. The acquisition is expected to strengthen Granules India's position in the pharmaceutical industry and may lead to improved operational efficiency and supply chain control.
21Feb 25
Granules India to Expand Global Presence with ₹1.93 Billion Acquisition of Swiss Peptide Specialist Senn Chemicals AG
Granules India Limited has approved the acquisition of a 100% stake in Senn Chemicals AG, a Swiss peptide specialist, for ₹1.93 billion. The acquisition, set to complete in H1 2025, will be executed through a new subsidiary. Senn Chemicals, founded in 1963, specializes in custom peptide development and manufacturing. This strategic move aims to expand Granules' global presence in peptide-based applications across pharmaceuticals, cosmetics, and theragnostic industries. The deal is subject to Swiss regulatory approvals.