Dr. Reddy's Laboratories Receives EIR from USFDA for Andhra Pradesh Facility
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Dr Reddy's Labs Andhra Pradesh facility gets EIR from USFDA
The pharma major announced that it has received the establishment inspection report (EIR) from the United States Food & Drug Administration (USFDA) for its API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The inspection has been classified as voluntary action indicated (VAI) and has been closed accordingly said the firm. Click here to connect with us on WhatsApp On 7 June 2024, USFDA had issued form 483 with four observations post inspection at its Andhra Pradesh facility. The good manufacturing practices (GMP) inspection was conducted from 30 May 2024 to 7 June 2024 at the API manufacturing facility. Dr Reddy's Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products. The companys consolidated net profit shed marginally to Rs 1,392.40 crore in Q1 FY25 as against 1,405 crore posted in Q1 FY24. However revenue from operations jumped 13.9% YoY to Rs 7,672.70 crore in Q1 FY25. Shares of Dr.Reddy's Laboratories shed 0.23% to Rs 6,682on the BSE. Powered by Capital Market - Live News Also Read X global affairs head Nick Pickles resigns after a decade long stint Stock Market Crash LIVE Updates: Sensex down 700 pts, at 81,500, Nifty tests 25,000; Financials drag Google Photos rolling out limited early access to Ask Photos AI assistant Haryana elections: Revolt in BJP; Cong-AAP hold alliance talks. Top updates Swiggy reports Rs 33 crore fraud by ex-employee, files legal complaint
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Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant
Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement. Click here to connect with us on WhatsApp As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility. Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE. Also Read Dr Reddy's Labs Q4 profit jumps 36% led by US growth, new products Chandrasekaran's FY24 pay rises 20% to Rs 135.3 cr on profit commission SC grants bail to ex-promoter of Bhushan Steel in money laundering case Lenovo showcases new AI PC concept with 'Smart Lid' that follows users ASUS brings laptops powered by new Snapdragon X Plus, India launch likely
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Dr. Reddy's Laboratories has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration for its Active Pharmaceutical Ingredient (API) manufacturing facility in Srikakulam, Andhra Pradesh. This development signals the closure of the FDA inspection conducted in July 2023.
FDA Inspection Closure
Dr. Reddy's Laboratories, a leading Indian pharmaceutical company, has announced the receipt of an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Srikakulam, Andhra Pradesh 1. This development marks a significant milestone for the company, as it signifies the successful closure of the FDA inspection conducted at the facility in July 2023.
Importance of EIR
The issuance of an EIR is a crucial step in the regulatory process, indicating that the USFDA has completed its evaluation of the facility and found it to be in compliance with current Good Manufacturing Practices (cGMP) 2. This positive outcome is essential for pharmaceutical companies operating in the global market, particularly those exporting to the United States, as it ensures the quality and safety of their products.
Facility Details and Inspection History
The Srikakulam facility, which specializes in the production of Active Pharmaceutical Ingredients, plays a vital role in Dr. Reddy's supply chain. The recent inspection, conducted from July 3 to July 7, 2023, resulted in the issuance of a Form 483 with two observations 1. These observations are typically made when inspectors identify conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related regulations.
Company Response and Resolution
Following the inspection, Dr. Reddy's Laboratories took prompt action to address the observations made by the FDA. The company's proactive approach in responding to and resolving these issues has likely contributed to the successful closure of the inspection and the subsequent issuance of the EIR 2. This demonstrates the company's commitment to maintaining high quality standards and regulatory compliance.
Market Impact and Future Outlook
The receipt of the EIR is expected to have a positive impact on Dr. Reddy's operations and market standing. It provides reassurance to stakeholders, including customers and investors, about the company's ability to meet stringent regulatory requirements. Furthermore, this development may potentially pave the way for smoother approvals of new products manufactured at the Srikakulam facility, enhancing Dr. Reddy's competitive position in the global pharmaceutical market 12.
Industry Context
This event highlights the ongoing scrutiny that pharmaceutical manufacturing facilities face from regulatory bodies like the USFDA. For Indian pharmaceutical companies, which are major suppliers to the US market, maintaining compliance with FDA regulations is crucial for sustaining and expanding their presence in the lucrative US pharmaceutical market. Dr. Reddy's successful navigation of this inspection process sets a positive example for the industry and reinforces India's position as a key player in the global pharmaceutical supply chain.
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