SeQuent Scientific (SeQuent) has received an US FDA approval for its API drug manufacturing facility at Mangalore, Karnataka (SeQuent Mangalore). 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 is engaged in the development and manufacture of APIs and API Intermediaries.
The facility has earlier received quality approval from TGA, Australia and certified by World Health Organisation, Geneva under its Prequalification’s of Medicines Programme.
Dr Gautam Kumar Das, Executive Director, said, “The US FD A approval endorses our commitment to ensure strong regulatory compliance as well as our dedication to offer quality products through research. Being the first ever for the company, this approval will further rejuvenate us in establishing SeQuent among the finest global API Manufacturers.”
SeQuent Mangalore specialises in niche and difficult to manufacture APIs and has five of its APIs pre-qualified by WHO Prequalification of Medicines programme. It has filed more than 30 drug master files covering US FDA, Europe, WHO, Australia, Canada with several more niche APIs in the pipeline for future filings.
EP News Bureau – Mumbai