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.
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."
