More Stories

Informist, Tuesday, Jul. 21, 2026

 

Please click here to read all liners published on this story

--Granules India: See Oncology as a huge area for growth
--CONTEXT: Granules India Apr-Jun consol EBITDA margin 23% vs 20% a yr ago
--Granules India: EBITDA margin to continue at current level going forward
--Granules India: Strong growth seen in peptide ops Q2, beyond
--Granules India: Seven out of eight plants fully compliant with US FDA norms
--Granules India: Waiting for US FDA response on Gagillapur plant
--CONTEXT: Comments by Granules India mgmt at post earnings conference call
--Granules India: Remediation work on Gagillapur plant completed

 

By Narayana Krishna and Gunjan Rajput

 

HYDERABAD/NEW DELHI – Granules India Ltd. is expecting a resolution to its key manufacturing unit located in Gagillapur, Hyderabad, which has received a warning letter from the US Food and Drug Administration. In a post-earnings conference call, Granules India management expressed confidence that the remediation process to get the plant fully compliant is completed, and it is waiting for the agency to respond.

 

Granules India's Gagillapur facility remained under a US FDA warning letter issued in Feb. 2025, following an Aug. 2024 inspection that highlighted serious current Good Manufacturing Practice or cGMP violations, including inadequate facility maintenance, risks of microbial contamination in air handling systems, and data integrity concerns.

 

These regulatory actions led the US FDA to withhold review of pending approvals linked to the site, although ongoing supplies to the US market continued without disruption. The company progressed remediation efforts by engaging external consultants to strengthen compliance systems and moved toward the final stages of corrective actions, with a re-inspection expected to address the outstanding observations.

 

Granules India management said seven out of eight manufacturing facilities that the company owns fully comply with the US FDA norms. Production is still taking place at the Gagillapur facility, though new approvals were blocked, the management said. Once the US FDA gives its clearance, several high-value products will get approvals.

 

The company reported a consolidated net profit of INR 1.80 billion for the June quarter, up 60% on year. The consolidated revenue was at INR 14.77 billion for the June quarter, up 22% on year. 

 

Granules India is expecting its earnings before interest, tax, depreciation, and amortisation margin at the current levels of 23% going forward. The company reported its EBITDA margin for the June quarter at 23% against 20% a year ago. The company is expecting its spending on research and development at 5.5-6.0% of total sales for 2026-27 (Apr-Mar).  

 

"We view R&D as the foundation of our future revenue, focusing on high-barrier areas such as CNS (central nervous system), oncology, and complex formulations, where we can build a differentiated position. These investments are steadily converting into filings and a healthy launch pipeline, including potential first-to-file opportunities," the company said.

 

Granules India management said the oncology segment is going to be the huge growth driver going forward, and nine to 13 new products are at various stages of development. By 2028-29 the company is expecting to launch its own product, which is developed in-house.

 

The company is expecting to launch nine new products in the US in FY27, while there are 18 product approvals pending with the US FDA.

 

Granules India is expecting robust growth in its contract development and manufacturing organisation business focused on peptide synthesis. The company is expecting to reach the $50 million revenue mark in the medium term, with an aim to multiply it several times in the next five years, the management said. The company said there is a strong growth opportunity for the peptide CDMO business in Jul-Sep and beyond in the current financial year.

 

On Tuesday, Granules India shares closed flat at INR 875.70 on the National Stock Exchange.  End

 

US$1 = INR 96.24

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Deepshikha Bhardwaj

 

For users of real-time market data terminals, Informist news is available exclusively on the NSE Cogencis WorkStation.

 

Cogencis news is now Informist news. This follows the acquisition of Cogencis Information Services Ltd. by NSE Data & Analytics Ltd., a 100% subsidiary of the National Stock Exchange of India Ltd. As a part of the transaction, the news department of Cogencis has been sold to Informist Media Pvt. Ltd.

 

Informist Media Tel +91 (22) 6985-4000

Send comments to feedback@informistmedia.com

 

© Informist Media Pvt. Ltd. 2026. All rights reserved.