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“This classification does not impact the ongoing manufacturing, distribution, or sale of existing products from the site,” Granules clarified further.
Granules India’s Gagillapur facility was handed a form 483 with six observations in the month of September and the company said in its exchange filing on Wednesday that it has taken a proactive, voluntary and comprehensive remediation plan to address the six observations.
“As part of this effort, we voluntarily paused manufacturing and dispatches in September to conduct a thorough risk assessment, ensuring no product contamination or patient safety concerns,” the company said, adding that operations and dispatches have resumed since this assurance.
Robust corrective and preventive actions (CAPAs), oversight by an independent third party, continued product testing for risk assessment and regular monthly progress updates to the US drug regulator are some of the steps that Granules plans to take as part of its voluntary remediation plan.
Till date, 80% of the CAPAs have been completed, as per Granules, and the rest are on track for closure by March 2025. “We are now seeking a meeting with the USFDA to present our progress and request a potential reinspection,” Granules added in its statement.
The company further said that its growth trajectory remains robust and diversified and that its strategy is not solely dependent on the new product approvals from the Gagillapur facility. Key drivers for growth now include new launches from its new US facility, growth from large-volume products in the US and Europe, capacity addition and commercialisation of greenfield formulations facility at Genome Valley, value chain advancements in Europe and its expanding oncology pipeline from its Unit V.
“These initiatives ensure sustained performance as we work towards resolving the OAI status and reinforce our commitment to compliance,” Granules said.
“When you are fully invested into a company, and when the valuations are at premium level, there is no scope for any error. That’s what the learning is from this market, particularly mid cap and small cap companies, wherein the players are most opportunity given, wherein they would probably try and create these counters as much as they could in a given period of time. So one disappointment or one bad news, as we want to call it, is, having the market is not kind enough in holding those stocks on the fundamental reasons,” Deven Choksey of DRChoksey Finserv told CNBC-TV18.
Shares of Granules India ended 10% lower on Tuesday following the OAI classification. The stock though, is in the F&O ban today, which means no new positions can be created in the stock.
Also Read: Granules India’s loss is which pharma company’s gain?
First Published: Dec 4, 2024 8:47 AM IST
