OneSource Pharma-Hikma get regulatory approval to promote generic Ozempic in Saudi Arabia


Contract drug producer OneSource Specialty Pharma acquired approval for its generic model of Ozempic in Saudi Arabia, clearing the trail for promoting the type-2 diabetes and weight-loss drug with its accomplice Hikma Prescribed drugs PLC.

Hikma is OneSource’s unique commercialization accomplice for the Center East and North Africa (MENA). The approval from the Saudi Meals and Drug Authority (SFDA) will allow its entry into Saudi Arabia, one of many largest markets for Ozempic and different weight administration/loss medicine.

The unique partnership will assist the corporate “capitalize on rising demand for this product” and underscores the ambition of each corporations to extend entry to high-quality reasonably priced generic drug alternate options for sufferers throughout the area, OneSource mentioned in a press release on Wednesday.

Below the settlement, OneSource will manufacture and provide semaglutide from its facility in Bengaluru and Hikma will use its business attain and institutional relationships within the area to widen availability of the drug.

“We’re assured that collaborating with Hikma, the biggest pharmaceutical firm within the MENA area by gross sales, will give us a powerful platform to scale entry to this vital remedy throughout each personal and institutional clients,” chief government officer and managing director Neeraj Sharma mentioned within the assertion.

World increase

OneSource is gearing as much as money in on the large demand for generic semaglutide pens as innovator Novo Nordisk is ready to lose patent exclusivity in over 80 nations this 12 months for the drug, identified by manufacturers Ozempic and Wegovy.

Sharma advised Mint in November that OneSource is fast-tracking a $100 million capability growth to faucet into the worldwide increase in weight-loss medicine. He mentioned the corporate is ready for the market growth when it comes to manufacturing and regulatory approvals for its services.

As a contract producer, OneSource’s positive factors depend upon companions getting approvals on time. In Q3, its income dropped 26% YoY to 290.3 crore ($33.1 million) after semaglutide approvals had been delayed in Canada, the place the patent has expired.

Its Ebitda dropped 88% and the Ebitda margin contracted to six% from 36% a 12 months earlier. The agency is concentrating on $500 million in income by FY28, Sharma advised Mint in November.



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