Cohance Lifesciences' Telangana units gets Form FDA 483 with observations from US FDA
In a regulatory filing made on Saturday (05 September 2026), the company informed that the US FDA had inspected the Cohance's formulation (FDF) plant located at Shamshabad, Telangana, from 27 August 2026 to 4 September 2026.
The inspection concluded with the issuance of a Form FDA 483 containing four observations.
The company has initiated appropriate corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline, Cohance Lifesciences said in a statement.
Cohance Lifesciences, formerly Suven Pharmaceuticals, is an innovator-focused global CRDMO formed through the merger of Cohance Life Sciences into Suven Pharmaceuticals. It is a technology-driven, integrated CDMO platform offering development and manufacturing solutions across complex APIs, performance materials, agrochemicals, ADCs, oligonucleotides and advanced chemistries for global pharmaceutical and life sciences customers.
The company had reported a consolidated net loss of Rs 24.12 crore in the quarter ended June 2026 as against net profit of Rs 48.88 crore during the previous quarter ended June 2025. Sales declined 23.13% to Rs 422.26 crore in Q1 FY27 as compared with Q1 FY26.
The scrip shed 0.78% to end at Rs 456.55 on the BSE on Friday.
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