Granules India Plans To Resume Normal Operations At Gagillapur Facility By Q3

Granules India Ltd. expects steady improvement at its troubled Gagillapur facility in Hyderabad and aims to resume normal operations by the third quarter of the current financial year.

The remediation at the Gagillapur facility is ongoing and will continue for a few more quarters, likely Q1 and Q2, according to Chairperson Krishna Prasad Chigurupati.

"We expect to approach the US FDA around August to request a re-inspection. So, it will definitely take a little more time," Chigurupati told NDTV Profit in a conversation on Thursday.

"It will be a steady improvement as the remediations are being done, the production will slowly ramp up and I think Q3 should be expected to be normal," the managing director said.

Granules India faced a setback after the FDA issued a warning to the company in February 2025 over some compliance concerns at the Gagillapur facility in Hyderabad. The inspection at the facility was conducted by an FDA team in August 2024. Despite the compliance issues, the company has resumed staggered production at the site while addressing regulatory concerns.

"We've had some good product launches in the US and the recently commercialised GLS facility at Genome Valley will also begin contributing to production," the CMD said. "We believe we'll be able to make up for the shortfall and once the Gagillapur facility is fully operational again, things should improve significantly."

In April, the company also acquired Senn Chemicals AG, a Switzerland-based contract development and manufacturing organisation.

"As we observed their capabilities, we realized that acquiring the company would give us a strong jumpstart in the peptide business. The plan is for Senn to continue the CDMO business in Switzerland, while we establish manufacturing facilities in India to produce GLP-1 APIs and eventually move into formulation through contract manufacturing," he explained.

With the GLP-1 (used mainly to treat type 2 diabetes) market projected to reach $100–150 billion by 2030, Granules India is eyeing this opportunity as a valuable jumpstart in this critical segment. Despite rising competition in the GLP-1 space, Chigurupati emphasised the immense growth potential in the sector, even if generics capture only a fraction of the projected market.

"Our focus isn't limited to GLP-1s... They're just a starting point. There are many other peptides and therapeutic areas where these capabilities apply," the top executive said.