Piramal Pharma declines after US FDA issues Form 483 with 6 observations to Turbhe unit

In a regulatory filing made after market hours yesterday, the pharmaceutical company stated that the US FDA had conducted a General GMP inspection at its Turbhe facility from 11th February 2025 to 17th February 2025.

On conclusion of the inspection, a Form-483 was issued with 6 observations. 'Observations are largely around improvement of procedures and practices and not related to data integrity.

The company is preparing a detailed response to said observations, which will be submitted to agency within stipulated timelines,' Piramal Pharma said in a statement.

Piramal Pharma (PPL) is a part of the Piramal group of companies. The pharmaceutical product portfolio of the company can be categorised into contract development and manufacturing organisations (CDMO), complex hospital generics (critical care), and consumer healthcare (OTC).

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