Cohance Lifescience Gets USFDA Form 483 With Four Observations at Telangana Plant

Cohance Lifescience on Saturday said it has received a US Food and Drug Administration (USFDA) Form 483 containing four observations following an inspection of its formulation facility in Shamshabad, Telangana. In an exchange filing, the company said the USFDA inspection was conducted from August 27 to September 4, 2026, at its finished dosage form (FDF) manufacturing plant. The inspection concluded with the issuance of a Form FDA 483 with four observations.

Cohance Lifescience said it has initiated appropriate corrective and preventive actions (CAPA) and will submit its response to the US regulator within the stipulated timeline. The company did not disclose details of the observations. It said it remains committed to maintaining high standards of quality and ensuring regulatory compliance. A USFDA Form 483 is issued by agency inspectors when they identify conditions or practices during an inspection that may potentially violate applicable regulatory requirements.

The issuance of the form does not by itself represent a final determination of non-compliance, with the company generally given an opportunity to respond and address the observations. The regulatory development comes at a time when Cohance is expanding its presence in advanced therapies, particularly antibody-drug conjugates (ADCs), which are increasingly being used as targeted cancer treatments.

The company recently announced plans to invest a combined $18 million in New Jersey-based NJ Bio and Aruka Bio as part of its strategy to strengthen its position in the ADC segment. Of the total investment, Cohance plans to invest $13 million in NJ Bio and a further $5 million in Aruka Bio. Following completion of the transaction and an initial equity allocation to Jain, Cohance is expected to directly control 65 per cent of Aruka Bio, while NJ Bio will hold a 25 per cent stake and Jain will hold the remaining 10 per cent. Meanwhile, Cohance Lifescience shares ended Friday's trading session more than 1 per cent higher.

Despite the day's gains, the stock has faced significant pressure over the past year, declining more than 50 per cent. The shares were priced at Rs 456.55 and remained 56.20 per cent below their 52-week high of Rs 1,038.90. The stock has also closed lower in four of the last 10 trading sessions.

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