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Dr Reddy’s CTO-6 in Srikakulam, AP, facility assessment concludes successfully after US FDA’s VAI inspection

Our Bureau, Bengaluru
Friday, September 6, 2024, 15:15 Hrs  [IST]

Dr Reddy’s, a global pharmaceutical company, has announced that  further to its intimation of June 7, 2024, on the inspection conducted by the United States Food & Drug Administration (FDA) at its active pharmaceutical ingredients (API)  manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh, the company has received the Establishment Inspection Report (EIR).
 
The US FDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is closed under 21 CFR 20.64(d)(3), stated Hyderabad-based company in its note to the bourses.
 
Dr Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, the company committed to providing access to affordable and innovative medicines. Its portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

 

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