Alkem Laboratories stated that US FDA has issued an Establishment Inspection Report (EIR) for the Company’s manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017.
In response to the two Form 483 observations issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.
Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and neutraceutical products. Established in 1973, it produce high-quality branded generics, generic drugs, active pharmaceutical ingredients and neutraceuticals, which we market in India and over 50 countries internationally. With a comprehensive portfolio of over 700 brands covering all the major therapeutic segments and a robust pan-India sales and distribution network, we have been ranked amongst the top ten pharmaceutical companies in India in terms of domestic sales for the past 13 years.