OneSource Specialty Pharma Ltd announced on Friday (April 17) that it has received the renewal of the European Union Good Manufacturing Practices (EU-GMP) certification for its flagship Unit II manufacturing facility in Bengaluru. According to reports from CNBC TV18, the certification follows an inspection by a European regulatory authority and applies to the company's integrated biologics manufacturing site, which handles both drug-substance and drug-product operations.
The Unit II facility maintains comprehensive capabilities including drug-device combinations and sterile injectable products, as reported by CNBC TV18. The facility operates with an isolator-based filling system that ensures no contamination during the critical stage when the drug is filled into cartridges. The automated system can fill 150 to 200 cartridges per minute, with current daily production at around 50,000 to 55,000 cartridges per day and 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 on Friday, according to CNBC TV18. The positive market response reflects investor confidence in the company's regulatory compliance and manufacturing capabilities.
GLP-1 drugs, widely known for their role in weight loss and diabetes management, are experiencing rapid global adoption, as reported by CNBC TV18. 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 mid-2030s, driven by rising demand and improved access.
According to Neeraj Sharma, Managing Director and CEO of OneSource Specialty Pharma, as reported by CNBC TV18, injection pens used to deliver semaglutide are significantly more expensive than vials due to manufacturing complexity, automation requirements and stringent sterility standards. The key benefit of pens is convenience, allowing patients to self-administer at home typically once a week, which vials cannot offer.
