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In a regulatory filing on Wednesday, Dr. Reddy's Laboratories said it has received a Notice of Non-Compliance (NON) from Canada's Pharmaceutical Drugs Directorate regarding its Semaglutide injection application, seeking additional information and clarifications. The company said it will respond promptly within the stipulated timeline and remains confident in the product's quality, safety, and comparability.
Semaglutide, a popular diabetes and weight-loss drug, is the generic version of Ozempic, developed by Novo Nordisk.
The update weighed on shares of Shaily Engineering Plastics, which manufactures drug delivery devices, including Semaglutide pens, for Dr. Reddy's. As per Shaily's FY25 annual report, Dr. Reddy's is among its top pharmaceutical clients.
During the first quarter of FY26, Shaily's management had highlighted that the healthcare segment's contribution to total revenue doubled to 31%, driven by rising demand for Semaglutide pens. To meet this demand, the company had installed 19 new injection moulding machines and a dedicated assembly and printing line, adding 25 million pens per annum in additional capacity.
The company also revealed plans to add another 25 million-pen line for a different Semaglutide variant, with a total capex of Rs 125 crore for FY26.
We have 60% of generic market share on semaglutide across the markets that are opening up, managing director Amit Sanghvi had said during the company's Q1FY26 earnings call.
The delay in Dr. Reddy's approval has raised concerns about potential near-term demand softness for Shaily's key product line.
While the delay may impact short-term demand visibility for Shaily, analysts remain optimistic about the long-term growth prospects of Semaglutide-linked supplies amid booming global demand for GLP-1-based therapies. As per Shaily's FY25 annual report, the global Semaglutide market, valued at $28.4 billion in 2024, is projected to reach $93.6 billion by 2035, growing at a CAGR of 10.5% on rising diabetes and obesity cases.
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