Dr. Reddys recalls Divalproex tablets

Dr Reddy's Laboratories has reportedly initiated a voluntary recall of anti-seizure drug Divalproex extended-release tablets from the US market owing to cGMP deviations noticed in certain batches of the product.

According to the US Food and Drug Administration (USFDA) report, the company has started recalling of Divalproex 100-count and 500-count bottles, totalling 33,958 bottles on April 11, 2019 after finding out that the product was exposed to humidity levels above 50 per cent during packaging.

Earlier this month, the company had received an Establishment Inspection Report (EIR) from USFDA for the company's Formulations Manufacturing Plant - 3 at Bachupally, Hyderabad. On April 15, the company entered into a definitive agreement to acquire a portfolio of 42 approved, non-marketed ANDAs in the US. The portfolio includes more than 30 generic injectable products. These products will require technology transfers and could be launched within the next one to two years. The value of the total addressable market for these products in the US is approximately US$645 million for the calendar year ending in December 2018, according to IQVIA.

Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas