Stories
Cohance Lifesciences Shares Jump Despite USFDA Observations at Andhra API Unit
- •Cohance Lifesciences shares rose nearly 5.5% on Monday, September 21, despite its API manufacturing facility in Jaggaiahpet, Andhra Pradesh, receiving five USFDA observations.
- •The USFDA issued a Form 483 with five observations after an inspection conducted from September 14 to September 19, 2026, for potential regulatory violations.
- •Cohance has initiated corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline, reaffirming its commitment to quality.
- •This marks the third instance of USFDA observations for Cohance facilities recently, following inspections at its Shamshabad (Telangana) formulation unit and Pashamylaram (Hyderabad) manufacturing facility.
- •The company also plans to invest $18 million in NJ Bio and Aruka Bio to expand its presence in antibody-drug conjugates (ADCs), a class of targeted cancer treatments.
Key Questions Answered
Shares of Cohance Lifesciences rose nearly 5.5% on Monday, September 21, trading higher at ₹460.2 despite receiving a Form 483 with five observations.
Earlier in the month, Cohance announced plans to invest a combined $18 million in NJ Bio and Aruka Bio to deepen its push into antibody-drug conjugates. The company will invest $13 million to increase its ownership in NJ Bio for research and manufacturing, and $5 million in Aruka Bio for developing experimental ADC drugs.
In early September, Cohance disclosed a Form 483 with four observations for its Telangana formulation facility following an August-September inspection. Additionally, the USFDA issued five observations in August following an inspection of its Hyderabad manufacturing facility in July and August.
