Hotline: 1800 102 2007
X
Search Business Opportunities
Feb, 26 2018

Dr Reddy’s Srikakulam Plant Receives EIR from USFDA

The Pharma major has received the EIR by USFDA for their formulations plant in Srikakulam, Andhra Pradesh.

US Food and Drug Administration has granted the Establishment Inspection Report (EIR) to the pharmaceutical company, Dr Reddy’s, for its formulations facility in Srikakulam, Andhra Pradesh.

The company had informed in April 2017 about the completion of its audit for API manufacturing plant that is located in Andhra Pradesh. Two observations were also issued by the US drug regulator of which the pharma major had mentioned.  Though they have not mentioned the contents of EIR, the company has stated that USFDA has maintained the status of Official Action Indicated (OAI) for their Srikakulam plant.

Dr Reddy’s was quoted saying in a regulatory filing that “FDA has asked us for more details. We are providing those details and continuing to engage with FDA for resolution of pending issues.”

The OAI status is considered to be equal finding conditions that are objectionable at the audit site. It is also an indication of sanctions by FDA that are regulatory and/or administrative.

Comment
Related opportunities
  • Career Counselling & Brain Programming
    About Us: Academic Evolutionz (AE) office is located Delhi, India. Our..
    Locations looking for expansion Delhi
    Establishment year 2011
    Franchising Launch Date 2018
    Investment size Rs. 5lac - 10lac
    Space required 100
    Franchise Outlets -NA-
    Franchise Type Unit, Multiunit
    Headquater New delhi Delhi
  • Ice creams & Yogurt Parlors
    About : Ice Cream factory is an innovative live ice cream..
    Locations looking for expansion Maharashtra
    Establishment year 2012
    Franchising Launch Date 2017
    Investment size Rs. 10lac - 20lac
    Space required 225
    Franchise Outlets -NA-
    Franchise Type Unit, Multiunit
    Headquater Mumbai Maharashtra
  • About Us: Zota Healthcare Limited manufactures and markets pharmaceutical products in..
    Locations looking for expansion Maharashtra
    Establishment year 2017
    Franchising Launch Date 2018
    Investment size Rs. 5lac - 10lac
    Space required 200
    Franchise Outlets -NA-
    Franchise Type Unit
    Headquater Mumbai Maharashtra
  • Dairy/F&V Stores
    About Us : Moo Cow was started aiming to be the bigest..
    Locations looking for expansion Delhi
    Establishment year 2010
    Franchising Launch Date 2011
    Investment size Rs. 1 Cr. - 2 Cr
    Space required 100
    Franchise Outlets -NA-
    Franchise Type Unit
    Headquater New delhi Delhi
Insta-Subscribe to
The Franchising World
Magazine
For hassle free instant subscription, just give your number and email id and our customer care agent will get in touch with you
OR Click here to Subscribe Online
Daily Updates
Submit your email address to receive the latest updates on news & host of opportunities