Orchid Pharma Facility Gets Seven Observations After FDA Inspection
The Alathur API facility has also secured the renewal of its EU Good Manufacturing Practice certificate following a successful inspection.
Orchid Pharma Ltd. received seven "minor" observations after the US Food and Drug Administration conducted a surprise inspection at its active-pharmaceutical-ingredient facility in Tamil Nadu, according to an exchange filing on Wednesday.
The inspection was conducted from Feb. 10 to Tuesday at the Alathur facility, which specialises in the production of cephalosporin antibiotics, a critical class of life-saving drugs. None of the observations pertain to the data integrity of the facility, it said.
"This successful inspection maintains Orchid Pharma's distinguished position as India's only US FDA-approved facility for Sterile Cephalosporins," it said. "The company aims to maintain the highest standards in pharmaceutical manufacturing to ensure continuous supply to the US and global markets.
The Alathur API facility has also secured the renewal of its EU Good Manufacturing Practice certificate following a successful inspection. "This further validates the facility's compliance with European regulatory requirements and its capability to serve global markets," it said.
Established in 1992 as an export-oriented unit, Orchid Pharma is a vertically integrated company spanning the entire pharmaceutical value chain with established credentials in research, manufacturing and marketing.
Shares of Orchid Pharma closed 1.82% higher at Rs 823.95 apiece on the National Stock Exchange, compared to a 0.05% decline in the benchmark Nifty. The share price has fallen 24.76% in the last 12 months.
Three analysts tracking the company have a 'buy' rating on the stock, according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 88%.
