Hyderabad-based pharmaceutical company Granules India expects its Gagillapur facility to receive US Food and Drug Administration (USFDA) approval for new drug applications (NDAs) by the first quarter of FY26. The facility was recently classified as “official action indicated” (OAI) by the USFDA after an inspection. An OAI status suggests that the site’s remediation efforts need further improvements.
Granules had voluntarily paused production at the Gagillapur plant in September to review risks based on USFDA observations. Production resumed in October, but in a staggered manner. Despite the OAI classification, Granules continues supplying approved products from the facility.
Delayed approvals
Executive Director Priyanka Chigurupati acknowledged a potential delay in approvals for abbreviated new drug applications (ANDAs), initially expected in Q4FY25 or Q1FY26. However, she expressed confidence that things would normalise soon. “We believe the ANDAs expected in Q1FY26 will remain on track,” she stated.
Priyanka also noted that none of the concerns raised in the USFDA’s Form 483 observations warrant a warning letter or import alert. The company has engaged external US agents and customers, who also do not foresee major issues.
Remedial measures and inspections
Chairman Krishna Prasad Chigurupati clarified that while outcomes with the USFDA are unpredictable, Granules has completed most remedial measures and established clear timelines for remaining tasks. Regular updates are being shared with the USFDA, and the company has employed a third-party consultant to enhance cleaning protocols and cross-contamination controls.
Legacy and growth markets
Granules’ legacy products, including paracetamol, metformin, and ibuprofen, remain in high demand. The US and Europe account for the largest share of revenue, with North America contributing 79%, followed by Europe (10%), India (2%), and other regions.
The company is also diversifying its product portfolio. New oncology drugs are set to launch from its Vizag facility, with key filings planned in early 2025. Granules’ Genome Valley facility is expected to reach a capacity of 10.5 billion units annually by FY26.
This strategic focus on innovation and global markets positions Granules for steady growth in the coming years.
