Granules India Confident in USFDA Compliance, Focuses on New Products
Granules India, a Hyderabad-based pharmaceutical company focused on the US market, anticipates that new drug applications from its Gagillapur facility in Hyderabad will be approved by the US Food and Drug Administration (USFDA) in the first quarter of the next financial year (FY26).
Following a recent USFDA inspection, the Gagillapur site has been classified as Official Action Indicated (OAI), which suggests that while remediation measures have been taken, some issues raised by the USFDA remain unresolved. In response to the inspection, the company voluntarily halted production at the Gagillapur plant in September to evaluate any potential risks based on the USFDA’s observations. Production gradually resumed in October. Despite the OAI classification, Granules continues to supply approved products from the facility.
Priyanka Chigurupati, executive director, Granules India, said there might be a delay in the abbreviated new drug applications (ANDAs) expected to be approved in Q4FY25 or Q1FY26. But internally, the company is expecting everything to get back to normal. “With the re-inspections or whatever may come, we believe the ANDAs expected to be approved in Q1 should remain on track,” she added. Priyanka further said that she does not think that anything in the form 483 issued by the USFDA warrants a warning letter or an import alert.
“We have engaged external US agents and customers and none of them see significant issues”, she added.
Krishna Prasad Chigurupati, chairman and managing director clarified that one can never predict outcomes with the USFDA.
“However, we have completed most of the remedial measures and have clear timelines for others. We are sharing updates with the USFDA regularly. We believe we’re doing more than what they’ve asked of us in the warning letter. We are quite satisfied with our efforts and will wait to see the results”, he said.
Motilal Oswal said Granules was issued a form 483 with six observations for its Gagillapur site after the USFDA inspection in September.
“The observations were related to cleaning/maintenance, inadequate root-cause analysis, document management, procedures for in-process controls, and air purification units. The USFDA has now classified the inspection as OAI,” the analysts said.
The company has only three products pending approval from this site. It has responded to all the observations issued by the USFDA.
To remediate the facility, Granules has voluntarily paused manufacturing and distribution at the site. It has also employed an independent third-party consultant for the site's cleaning protocols and cross-contamination controls.
Motilal Oswal noted that to date, Granules has gone through 24 USFDA inspections since 2009. “Out of 24 inspections, Gagillapur (Medchal-Malkhajgiri) has been inspected six times. All the inspections received either voluntary action indicated (VAI) or no action indicated (NAI) classifications”, it added.
Krishna Prasad said its Genome Valley facility will touch 10.5 billion units per annum formulations capacity by early FY26. And, the European Union (EU) inspection of the facility is expected around that time.
Furthermore, Granules is launching new oncology products from its Vizag plants in the near term, analysts said.
The company is filing Ruxolitinib alternative salt (cancer drug) in January, Ruxo IR tablets for US and EU in March 2025.
As of Q2FY25, Granules draws 79 per cent of its revenues from North America, 10 per cent from Europe, and 2 per cent from India.
Priyanka said that in terms of absolute numbers growth will come from the US market, apart from Europe, Latin America, Middle-East and North Africa (Mena) and Southeast Asia.
India will still be a big market but primarily for active pharmaceutical ingredients (APIs) and intermediates.
In terms of percentage share, the US and Europe would be the leaders, followed by LatAm, Mena and Southeast Asia.
Granules’ focus on new products has led to 25 per cent of revenues coming from them. The legacy products of Granules include paracetamol, metformin, and ibuprofen, among others.
Priyanka said these legacy products are first-line defence products, and so, the demand would remain.
