US FDA finds failures at Goa plant of India's Cipla

11 October 2019

The US Food and Drug Administration has released a detailed Form 483 at the Goa injectable facility of Indian drugmaker Cipla (BSE: 500087), which contained 12 observations. This could impact or delay new drug launches in the USA.

Cipla’s US business contributes 22% of total sales. The Goa unit is an important facility for Cipla (accounting for 20%-25% of US sales; and one source product contributing 2.5% of total sales).

This April, Cipla’s US subsidiary InvaGen recalled an injection used to treat low testosterone from the US markets. It had been manufactured at Cipla’s Goa plant.

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