Dr. Reddys Laboratories Ltd.

In a recent inspection at Dr Reddy’s Laboratories’ manufacturing plant, the US Food and Drug Administration (FDA) found nine possible procedural deviations and in this context has sought an explanation from the drug maker. These observations largely relate to procedural and other compliances of the plant systems.

With this, the company is in the process of responding the agency within stipulated timeline, sketching down its remedial plans and necessary measures to fix the problem immediately. There were no implications on any activity at the plant and production continued in the normal course.

The plant, which manufactures active pharmaceutical ingredients and bulk drugs and is located Srikakulam district of Andhra Pradesh, was visited by the US Food and Drug Administration last week and in an investors’ judgment these observations were listed on an FDA Form ‘483’. However, according to the company, 483 observations are unlikely to affect the production of the company and therefore, it will continue as per normal routine.

Dr. Reddy's is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - the company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, bio-similars, differentiated formulations and NCEs.