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(14 Jun 2025, 14:28)

Syngene's Bengaluru-based facility gets 'NAi' status from US FDA

Syngene International said that the United States Food and Drug Administration (US FDA) conducted a good clinical practices (GCP) compliance inspection of the company’s facility located at Semicon Park, Bengaluru, from 09 to 13 of June 2025.


The inspection concluded successfully, with the facility found to be in compliance with the required regulations.

The inspection resulted in zero observations and no Form 483 was issued. The inspection has been classified as ‘no action indicated’ (NAI).

“The company remains commitment to high operating standards and rigorous compliance with global regulatory requirements across all its operations,” Syngene said in a statement.

Syngene International is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors.

On a consolidated basis, net profit of Syngene International declined 2.81% to Rs 183.30 crore while net sales rose 11.03% to Rs 1018 crore in Q4 March 2025 over Q4 March 2024.

The scrip had lost 1.57% to end at Rs 652.50 on the BSE on Friday.


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