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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze