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Cohance Lifesciences Jaggaiahpet API Plant Clears US FDA Inspection with Zero Observations

Cohance Lifesciences Jaggaiahpet API Plant Clears US FDA Inspection with Zero Observations

Cohance Lifesciences has announced that its API manufacturing facility in Jaggaiahpet, Andhra Pradesh, has successfully cleared a US Food and Drug Administration current Good Manufacturing Practices (cGMP) audit with zero Form 483 observations. The inspection was conducted over four days, from 8 to 11 September 2025, and concluded without any findings.

In a filing with stock exchanges, the company said this outcome reflects its commitment to the highest standards of regulatory compliance and quality in its operations. The Andhra Pradesh facility, part of Cohance’s network of API production units, will continue supplying high-quality pharmaceutical ingredients to both domestic and global markets.

Cohance Lifesciences, formerly Suven Pharmaceuticals, operates as a Contract Research, Development and Manufacturing Organisation (C-RDMO). The firm has been focusing on expanding its presence in active pharmaceutical ingredients (APIs), legacy generics, and complex specialty chemistries. The clean inspection result is expected to enhance its credibility with international regulatory authorities and customers.

Officials from Cohance said they will build on this success by maintaining rigorous quality controls and exploring further growth in regulated markets. The zero-observations outcome should help the company secure new business and reassure partners of its compliance capabilities.

More news about: engineering | Published by Darshana | September - 15 - 2025

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