India's Strides Arcolab got a second key facility approval from the FDA. Its oncology unit won the agency's nod for its new production plant in Bangalore, clearing the way for its partnership with Pfizer to shift into higher gear.
The two companies agreed last year to collaborate on the sale of 40 off-patent injectable drugs, mostly cancer meds. Strides would make the drugs and Pfizer would market them in the U.S. The deal was later expanded to cover other areas, including Japan and Europe, the Times of India reports.
Strides Vice Chairman Arun Kumar told CNBC India that the company expects FDA approval over the next few weeks for products to be made at its newly approved facilities. Strides has approval apps at the FDA for drugs worth $4 billion to $5 billion, Kumar said.
"With this approval and the recently announced approval for the Sterile Complex, we now look forward to scaling up our specialty business through the launch of highly specialized products for the U.S. market," Venkat Iyer, CEO of the oncology unit, said in a statement. Strides also has a collaboration deal with GlaxoSmithKline, as well as deals with other, smaller companies. But the Pfizer agreement is its biggest, Kumar said. "The Pfizer partnership is the most impactful and meaningful partnership that we have."
- see the release from Strides
- read the CNBC interview
- get more from the Economic Times