SeQuent Scientific has received Establishment Inspection Report (EIR) for its API Drug Manufacturing facility at Mangalore, Karnataka which was inspected by the USFDA in June 2015 as part of GMP compliance audit and now confirms the closure of the inspection. The previous USFDA inspection for this facility was in the year 2012. The facility continues its status of being acceptable by USFDA.
The SeQuent Mangalore facility is ISO 9001 certified for Quality Management systems and ISO 14000 certified for Environment Management systems. This state-of-the-art facility engaged in the development and manufacture of APIs and API Intermediaries. In addition to the USFDA, the site is also approved by TGA (Australia), and WHO (Geneva) and has four CEPs for its APIs (EDQM) with more in pipeline.
SeQuent Mangalore specializes in niche and difficult to manufacture APIs and has 5 of its APIs prequalified by WHO Prequalification of Medicines program. It has filed more than 30 drug master files covering USFDA, Europe, WHO, Australia, Canada with several more niche APIs in the pipeline for future filings.
