Cipla signals more US momentum with headroom for albuterol market share expansion, promising prospects for generic Brovana and strong launch line-up in FY23, but analysts also keep close eye on regulatory pre-approval inspection timelines.

Cipla signals more US momentum with headroom for albuterol market share expansion, promising prospects for generic Brovana and strong launch line-up in FY23, but analysts also keep close eye on regulatory pre-approval inspection timelines.

Cipla’s Avenue Therapeutics has received a second complete response letter from the US FDA regarding its new drug application for an intravenous formulation of tramadol. The company has disagreed with the FDA’s observations and said that it will continue to pursue regulatory approval for IV tramadol.

Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.