Laurus Labs

Quality & Systems

Quality Control and Quality Assurance

We believe we have adopted uniform manufacturing standards across all our facilities to achieve standardized quality for all our markets. The provision of high quality products is a key differentiator in our business, critical to our continued success and the maintenance of long-term relationships with our customers. We are committed to providing high quality products to our customers and to meet this commitment, we have implemented current good manufacturing practices across our manufacturing sites, encompassing all areas of business processes right from supply chain to product delivery. This enables us to maintain consistent quality, efficiency and product safety. As of June 30, 2016, we had 486 personnel (20.3% of our employee total) performing quality control and quality assurance functions.

Our quality management systems applicable to chemical and process development, analytical development and testing, contract research and development, formulation development and manufacture of pharmaceutical products, have been certified by NQA, UK to be in compliance with BS EN ISO 9001:2008 until June 8, 2017. The Department of Drugs Control Administration, Hyderabad, Government of Telangana, has certified that our facilities conform to good manufacturing practice norms recommended by the WHO.

Our facilities are regularly inspected for compliance with current good manufacturing practices, and such compliance is assessed by the US FDA, WHO and other regulatory agencies. Our internal audit procedures are also regularly updated to comply with any changes in international regulatory requirements, such as US FDA and WHO. Our manufacturing facilities have received one or more approvals from the US FDA, WHO, PMDA, KFDA NIP Hungary and BfArM. The latest successful regulatory audits by the USFDA and WHO for our Units 1 and 3, the BfArM – Germany audit for Unit 2 and the US FDA inspection for our R&D center in Hyderabad occurred in April 2015, December 2015 and June 2016, respectively.