Mumbai, October 27 (Monday): Shares of Laurus Labs Ltd gained 2.37% to ₹948.35 in early trading, extending their upward momentum amid increased attention on compliance developments within the Indian pharmaceutical sector. The stock rose ₹21.95 from its previous close of ₹926.40, taking the company’s market capitalization to ₹513.70 billion on the NSE.
US FDA observations on Hetero Labs’ facility
According to a recent inspection report by the US Food and Drug Administration (FDA), Indian drugmaker Hetero Labs Limited received a Form 483 highlighting six major observations at one of its undisclosed warehouses in Vishakhapatnam. The facility reportedly stores active pharmaceutical ingredients (APIs), intermediates, and key starting materials for FDA-registered plants supplying APIs and finished drugs to the US market.
The FDA noted the absence of quality unit oversight and standard operating procedures (SOPs) for warehousing and handling APIs and intermediates. Inspectors also observed poor hygiene and pest control, citing instances of birds flying inside the warehouse, bird droppings on drums, bird nests within roof seams, and lizards and cats crawling between pallets and API drums.
These lapses raise concerns about storage integrity and potential contamination risks, prompting the FDA to require corrective measures.
Sectoral impact and investor focus
While the inspection pertains to Hetero Labs, the report has prompted a broader evaluation of quality standards across Indian pharma manufacturers exporting to regulated markets like the US. Laurus Labs, a major API producer and exporter, is seen as relatively better positioned given its track record of regulatory compliance and product diversification.
Analysts noted that the market’s response to the FDA’s observations was stock-specific, with investors likely rotating toward companies demonstrating consistent adherence to Good Manufacturing Practices (GMP) and transparent quality systems.
Stock Update:
- Current Price: ₹948.35
- Change: +2.37% (+₹21.95)
- Market Cap: ₹513.70 billion
- Day Range: ₹926.85 – ₹952.00
- Year Range: ₹459.55 – ₹952.00
- P/E Ratio: 75.09
- Dividend Yield: 0.17%
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