Dr Reddy’s Srikakulam plant gets EIR from USFDA

▴ medicircle-dr-reddys-srikakulam-plant-gets-eir-from-usfda
All facilities under warning letter are now determined as ‘voluntary action indicated’
The US FDA has closed inspection of Dr. Reddy’s Laboratories manufacturing facility in Sirkakulam, Andhra Pradesh.
The US Food and Drug Administration (USFDA) had issued a warning letter to the facility in November 2015, after inspecting it in 2014.
“We have received the establishment inspection report from the USFDA, for the Srikakulam facility, indicating closure of the audit and the inspection classification of this facility,” Dr Reddy’s Laboratories said in a regulatory filing.
With this, all facilities under warning letter are now determined as ‘voluntary action indicated’, informed the company.
Dr. Reddy's Laboratories is a multinational pharmaceutical company. The company was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.
Many people throughout the world do not have access to good health because they can’t afford expensive medicines. Dr. Reddy's Generic Formulations business addresses this urgent need by offering more than 200 high-quality generic versions of expensive innovator medicines—at a fraction of the cost—in over 80 countries around the world.
Generic Formulations, including tablets, capsules, injectables, and topical creams, is the largest part of our business portfolio, making products across the major therapeutic areas of gastrointestinal ailments, cardiovascular disease, pain management, oncology, anti-infective, pediatrics and dermatology.
In many emerging markets, our products are available under a brand name, such as Omez (Omeprazole), Nise (Nimesulide),Ketorol (Ketorolac Thromethamine), Stamlo (Amlodipine Besylate), Razo (Rabeprazole), among many others.
Tags : #DrReddys #USFDA #Sirkakulam #AndhraPradesh

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