Granules India focused on getting FDA nod for drug from Gagillapur by FY26

It had voluntarily paused production in September

Hyderabad-based US-focused pharma firm Granules India expects the new drug applications from its Gagillapur facility in Hyderabad to be approved by the US Food and Drug Administration (USFDA) in the first quarter of next financial year (FY26).

  The USFDA has classified the Gagillapur site as official action indicated (OAI) following a recent inspection. OAI implies that the remediation measures have some lacuna in addressing issues highlighted by the USFDA. The company had voluntarily paused production in the Gagillapur plant in September to reassess the potential risk on account of the USFDA observations, if any. Subsequently in October, production resumed in a staggered manner. With the OAI classification, Granules continues to supply the approved products. 

 

Speaking to Business Standard, 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  hoping for everything to get back to normal. We do expect approvals from our US site to come through as planned.

 

“We are corresponding with the FDA and are sending in our monthly responses as planned. We have engaged external US agents to help us with our responses and plan of actions. We are committed to compliance as our 40 year history has shown and will do everything to ensure the FDA is convinced with our way forward,” she said .

 

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 OAI. 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.