Cohance Lifesciences shares hit a fresh intraday high on Monday even as its Andhra Pradesh API plant received five USFDA observations.

This rise comes even though the news behind it isn’t entirely positive on the surface.

The US Food and Drug Administration, or USFDA, recently inspected Cohance’s active pharmaceutical ingredient facility at Jaggaiahpet in Andhra Pradesh.

The inspection ran from September 14 to September 19, and at the end of it, the USFDA issued a Form 483 listing five observations.

The company disclosed this through a regulatory filing on September 21.

A Form 483 is simply a list of items US inspectors flag during a plant visit that could potentially breach regulatory norms.

It does not mean any final action has been taken against the company.

Cohance has not shared the specific details of the five observations, but it confirmed that a Corrective and Preventive Action plan, commonly called CAPA, is already underway, and a formal response will be submitted within the required timeline.

This follows a busy couple of months on the regulatory front. Weeks earlier, the company’s formulation facility in Shamshabad, Telangana, received four observations following an inspection between August 27 and September 4.

Prior to that, in August, its Pashamylaram facility in Hyderabad had also received five observations, though the company clarified those did not involve data integrity concerns.

Separately, Cohance has been expanding its footprint in antibody drug conjugates, a category of targeted cancer treatment, with plans to invest a combined 18 million dollars in two firms, NJ Bio and Aruka Bio, subject to regulatory approvals.

At 13:50 pm, Cohance Lifesciences shares are currently trading at Rs 463.40 on the NSE.

Despite today’s rally, the stock remains down close to 11% on a year to date basis, though it has gained over 50% in the last six months.

Tired of missing hot stocks? Tradz by EquityPandit provides powerful tools like stock scans and more help you make informed trading decisions. Download now and take control of your portfolio!