- Category: Latest Updates
- Published on Friday, 03 May 2013 12:19
The facility is ISO 9001 certified for Quality Management systems and ISO 14000 certified for Environment Management systems
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
- SPARC gets US FDA response on Levetiracetam NDA
- Avery Dennison launches new solution to help stamp out product fraud
- Editorial Advisory Board
- GlobalData analysts focus on early detection and prevention of Alzheimer’s Disease
- Daara Patel - PPP model is necessary to make healthcare accessible to all
- Dr Purvish Parikh - Focus should be on prevention rather than treatment
- Amit Backliwal - We need to dramatically change our speed of development