Strides Arcolab gets USFDA nod for Granisetron Hydrochloride injection

Total approvals in sterile space at 20

Strides Arcolab Limited (Strides) today announced receipt of ANDA approval for two abbreviated New Drug Applications (ANDAs) filed with Para IV certification to market Granisetron Hydrochloride injection, an antiemetic used to prevent nausea and vomiting caused by chemotherapy.  Granisetron hydrochloride injection will be made available in 0.1 mg per mL and 1.0 mg per mL single-dose vials, and 4.0 mg per 4mL multi-dose vials. According to 2009 IMS data, the U.S. market for Granisetron Hydrochloride injection approximated $ 26 million.

This is expected to be launched shortly. 

Ravi Seth, Chief Executive Officer – International Operations of Strides stated : “With 20 ANDA approvals in the sterile injectables space , Strides has a significant and growing presence in the US market . Each approval constitutes an important milestone for the Strides Sagent partnership which continues to acquire scale . “

Granisetron is the fourth product being launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the U.S. market which will be marketed by Sagent . 

About Granisetron Hydrochloride
Granisetron hydrochloride injection is the generic equivalent of Kytril® from F. Hoffmann-La Roche AG.  Granisetron hydrochloride injection is indicated for the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

About Strides Arcolab Limited:
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across 6 countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore. Additional information is available at the company’s website at www.stridesarco.com.

About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products.  Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients.  Sagent currently has more than 200 products in development.

To Discover Injectables Excellence™ and learn more about Sagent, please visit www.SagentPharma.com.