Ciron Launches New Sterile Manufacturing Facility
Part of the special news roundup of DCAT member companies for the DCAT Week ’17 Special Edition of DCAT Value Chain Insights (April 5, 2017)
Ciron Drugs & Pharmaceuticals, a Mumbai, India-based company that develops, manufactures, and exports finished pharmaceutical formulations, such as liquid injections, lyophilized injections, ophthalmic, nasal, and otic products, has launched its third automated sterile manufacturing facility in compliance with regulatory requirements by the US Food and Drug Administration, the UK Medicines and Healthcare Products Regulatory Agency, the European Union and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
In addition to its two existing manufacturing sites, the new facility expands Ciron’s capabilities in sterile generic formulations. The new 80,000 square-foot manufacturing facility is automated and equipped with quality control laboratory and stability units. The facility also uses quality management systems and document management systems software for paperless documentation. In terms of manufacturing output, the new facility can produce 200,000 units of ampuls per shift, 100,000 units of vials per shift, 80,000 units of lyophilized vials per cycle, and 40,000 units of eye drops per shift.