• search

Lupin gets US FDA approval for Ceftriaxone 10gm vials

Written by: Staff

New Delhi, Sep 14 (UNI) Lupin Pharma today said the US Food and Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for its Ceftriaxone Injection 10 gram vials (Pharmacy bulk pack).

Ceftriaxone is the generic equivalent of Rocephin marketed by Roche.

The Company had launched the 250 mg, 500 mg, 1 g and 2 g strengths of Ceftriaxone vials upon patent expiry in July, 2005.

''The approval of our Ceftriaxone 10mg ANDA completes the entire Ceftriaxone product family. Again our preparedness for execution enables us to launch this product immediately,'' company's Managing Director Dr Kamal Sharma said.

The Company has agreements with Baxter Healthcare Corporation for the US hospital market and with Henry Schein for the physician offices.

With this approval, the company now has 15 ANDAs approved by the US FDA.


For Daily Alerts
Get Instant News Updates
Notification Settings X
Time Settings
Clear Notification X
Do you want to clear all the notifications from your inbox?
Settings X
We use cookies to ensure that we give you the best experience on our website. This includes cookies from third party social media websites and ad networks. Such third party cookies may track your use on Oneindia sites for better rendering. Our partners use cookies to ensure we show you advertising that is relevant to you. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on Oneindia website. However, you can change your cookie settings at any time. Learn more