Sites and Contacts

Vizag, India

Overview

Our site in Vizag, India develops and manufactures small molecule APIs, new chemical entities (NCEs) and intermediates from kilograms to tons, supporting all phases of your drug’s lifecycle.

Home to more than 200 employees, the site comprises a combination of GMP and technical work areas, 140 cubic meters of vessel capacity manufacturing more than 500 tons of small molecule APIs.

This site features specialized technologies: a fully automated state-of-the-art production plant for mesalazine, electrochemical reactions, hydrogenations and cryogenic reactions.

Site Details

• One cGMP pilot plant
• Two commercial scale production units
• Four production trains
• Custom development and analytical laboratories
• cGMP kilo laboratory
• Strong regulatory history – most recent inspections:
  • CDSCO (IN), regularly, 2018
  • FDA (US), regularly, 2018
  • PMDA (JP), 2018
  • Government of Upper Bavaria, competent authority (Germany), regularly, 2017
  • KFDA (Korea), 2011

Other important facts

We take in pride in our long, regulatory track record; with the most recent site inspection in December 2018 by the US FDA resulted in ‘No Action Indicated’ outcome.

Please click here to find out about Vizag’s specific Corporate Social Responsibility Policy.