Sequent received US FDA approval for its API drug manufacturing facility at Mangalore [Bangalore]
BANGALORE: SeQuent Scientific Limited (SeQuent) on Tuesday announced that it has received the US FDA approval for its API Drug Manufacturing facility at Mangalore, Karnataka (SeQuent Mangalore). This facility has earlier received quality approval from TGA, Australia and certified by World Health Organisation, Geneva under its Prequalification's of Medicines Programme.
The SeQuent Mangalore facility is ISO 9001 certified for Quality Management systems and ISO 14000 certified for Environment Management systems. This state-of-the-artfacility engaged in the development and manufacture of APIs and API Intermediaries.
Commenting on the achievement, Dr Gautam Kumar Das, Executive Director, said, "The US FDA 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 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.