1 Jul 2016
Ahmedabad-based Torrent Pharmaceuticals Ltd will acquire a manufacturing unit of Hyderabad-based Glochem Industries Ltd.
The Visakhapatnam unit, approved by the US Federal Drug Administration (FDA) and European regulatory authorities, is a multi-product facility which can manufacture advance intermediates and active pharmaceutical ingredients (APIs). With the latest acquisition, Torrent Pharma, which currently has five formulation manufacturing units, will have three API units for the regulated markets. The acquisition will help the firm in vertically integrating its abbreviated new drug application (ANDA) filings in the future, it said in a statement.
An API is the main ingredient of a drug. ANDA is a filing made by a pharmaceutical firm to sell a generic version of an innovator’s product.
The agreement also includes the sale of a few drug master files. A drug master file is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more drugs.
“Acquisition of this site will further help in backward integration and scale-up of Torrent’s manufacturing capacity to meet the growing demand from the international markets,” Jinesh Shah, executive director (operations) at Torrent Pharma, said in the statement.
The Visakhapatnam facility has three blocks for advance intermediate manufacturing and four blocks for API manufacturing. It also has capabilities for on-site development and analytical method development, a quality control laboratory and a pilot plant.