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Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

Cohance's Jaggaiahpet API Plant Clears USFDA Inspection with Zero 483 Observations

Cohance Lifesciences has announced that the United States Food and Drug Administration (USFDA) has completed a general current Good Manufacturing Practices (cGMP) audit at its API manufacturing facility (API Unit1) located at Jaggaiahpet, Andhra Pradesh, with zero Form 483 observations.

In an exchange filing, the company revealed that the inspection was conducted from September 8, 2025 to September 11, 2025.

“We remain committed to maintaining the highest standards of quality and regulatory compliance in all our operations and will continue to ensure the manufacture and supply of high-quality pharmaceutical products for global markets,” it said.

A leading integrated Contract Development and Manufacturing Organization (CDMO), Cohance Lifesciences’ expertise spans small molecule APIs, Antibody Drug Conjugates (ADCs), and Nucleic Acid Chemistry. With state-of-the-art facilities in India and the US, the company is backed by advanced R&D centres at Genome Valley (Hyderabad), NJ Bio (Princeton, US), and Sapala Organics (Hyderabad). These centres are equipped with cutting-edge technologies, including 400 MHz NMR, HPLC, and flow chemistry reactors. 

More news about: quality / gmp | Published by Dineshwori | September - 12 - 2025 | 210

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