Strides gets US FDA inspection nod for manufacturing site in Florida

21 January 2020
fda_big

Indian drugmaker Strides Pharma Science (NSE: STAR) says its step-down subsidiary, Strides Pharma (SPI), has received a positive Establishment Inspection Report (EIR) from the US Food and Drug Administration for its facility in Riviera Beach, Florida, USA.

The EIR was issued as an outcome of the US FDA’s inspection of the facility in December 2019. This facility is one of the very few manufacturing facilities in the USA with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs.

Strides says it is one of the global leaders in Rx SGC with a vast portfolio of approved SGCs in the USA and other regulated markets. The inspection outcome will bolster the company’s fast-growing SGC franchise in the USA and will also help accelerate our foray into the private label opportunity with “in market for market” products.

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 account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
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

Today's issue

Company Spotlight





More Features in Generics