A severe shortage of the antibiotic vancomycin in the US has pushed the FDA’s approval for supplies from the new Bangalore plant of Strides Arcolab Ltd.
The drugmaker on Tuesday said it would start US shipments of vancomycin injection from the new sterile injectable complex this month. It is the first sterile product to come out of the facility.
Strides is among the three global players supplying the generic drug in the US. It said, “Vancomycin injection is currently facing a significant upswing in demand in the US and the approval of this product from the new facility offers Strides unconstrained capacities to meet the increasing demand.”
Mr Venkat Iyer, CEO, Agila Specialties, said,“The US FDA approval for the new site is an important milestone in scaling up our business in the US.
“With our unconstrained capacity, we are now well positioned to take advantage of the significant opportunity for injectable products in the US market. We will include the new facility in all the approved ANDAs thereby facilitating the launch of more products in the US in the coming quarters.”
Strides’ vancomycin injection, cleared by the USFDA in January 2009 from the first plant, takes up 70 per cent of the capacity of that plant. Although 33 injectable products out of 113 applications were approved for the US, sales have begun for only nine products coming out of the existing facility. Other USFDA approved drugs would also be shifted to the new plant to speed up their US launch, the company said.
Agila Specialties Pvt Ltd was carved out in 2009 to focus on oncolytics, penems, penicillins, cephalosporins, ophthalmics, peptides and biosimilars. Strides recently projected 45 per cent growth in its specialties business.