Cipla

The molecule binds two HER2 sites at once, which targets the HER2-low tumours that single-target conjugates treat poorly.

The inspection ran 13 to 17 July. A VAI classification means objectionable conditions were noted but the agency is not pursuing administrative or regulatory action, which is the outcome that keeps a plant shipping. It matters more here because this is a site Cipla owns inside the market it supplies.

Pithampur has drawn agency scrutiny three times since 2023, so this is a repeat site, not a first flag.

It is the first dry powder inhaler cleared from Cipla's own United States plants, with the commercial launch guided to the September quarter.

Operating margin dropped to 16.7 percent from 25.6 percent as raw-material costs rose 22.8 percent. North America revenue slid to 162 million dollars from 226 million a year earlier. Revenue edged up just 2 percent to 7,119 crore rupees, below what the street expected.