KBIL is committed to improve the effectiveness of the Quality System on a continual basis to produce the Bulk Active Pharmaceuticals by complying the cGMP and GLP as the constituent parts in integrating the total Quality as a package.

Quality Systems and Certification

KBIL has invested in extensive training to incorporate the cGMP into its operating systems. This gives the confidence in the Quality Assurance Systems

With its focus on Quality Systems, the Company has received several certifications from various regulatory bodies in USA, UK and Europe, etc.

ISO Certifications

The company has obtained ISO-9001 Certification (in year 1998) for its Quality Management System of manufacturing plant and the research facilities from SGS Yarsley International Certification Services Limited, UK and ISO-14001 Certification (in year 2000) for the Environment Management System from SGS International AG, Switzerland.

Good Manufacturing Practices (GMP) Certification

The company has obtained certification for being in compliance with World Health Organisation-Good Manufacturing Practices (WHO-GMP) for several products, which reflects the company's adherence to current Good Manufacturing Practices.

European Certificate of Suitability (CoS)

The company has obtained Certificate of Suitability for Pseudoephedrine HCl from European Directorate for Quality of Medicines (EDQM), France for the quality of medicines, which enables the company to market its product all over Europe. The company is in the process of filing applications for the Certificate of Suitability for several products.

US FDA

The company's manufacturing facility at Regadichelika, Nellore has been successfully inspected by the US FDA. The inspection was successfully carried out in _2003 without any 483.