The certification applies to the company’s integrated biologics manufacturing site, which handles both drug-substance and drug-product operations. The Unit II facility also has capabilities in drug–device combinations and sterile injectable products.
Last week, Neeraj Sharma, Managing Director and CEO of OneSource Specialty Pharma, said injection pens used to deliver semaglutide are significantly more expensive than vials, largely due to the complexity of manufacturing, automation requirements and stringent sterility standards.
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GLP-1 drugs, widely known for their role in weight loss and diabetes management, are seeing rapid global adoption. Semaglutide, which has gone off patent in India and is losing exclusivity across several emerging markets, is at the centre of this growth. The market for the drug is estimated at about $34.5 billion and is expected to expand to over $85 billion by the mid-2030s, driven by rising demand and improved access.
Explaining the cost differential, Sharma said, “Yes, it is significantly more expensive. However, the key benefit is convenience. Patients can self-administer at home, typically once a week. Vials do not offer that ease. Pens are more complex to manufacture, which reflects in the price.”
The manufacturing process begins in highly controlled sterile environments where human intervention is kept to a minimum. At the core of production is an isolator-based filling system that ensures no contamination during the critical stage when the drug, already formulated into liquid form, is filled into cartridges.
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“This is really the first major step in the entire value chain of GLP-1, where the drug… is filled on this line,” Sharma said, adding that the automated system can fill 150 to 200 cartridges per minute. However, actual daily output depends on batch sizes, with current production at around 50,000 to 55,000 cartridges per day, and the potential to scale up to 1.2–1.3 lakh units.
Shares of Onesource Specialty Pharma Ltd ended at ₹1,539.75, up by ₹33.80, or 2.24%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
