Page 5 - Dr Reddys
Dr Reddy's gets 4 observations from USFDA for Srikakulam plant
Drug major Dr Reddy's on Saturday said it has received four observations from the US health regulator USFDA for its facility at Srikakulam in Andhra Pradesh. The audit of the company's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing. Dr Reddy's further said that it would address the four concerns within the stipulated timeline. "The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations," said Dr Reddy's. It further said: "We will address them comprehensively within the stipulated timeline." As per the US health regulator, "an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and ...
 "Dr Reddy's gets 4 observations from USFDA for Srikakulam plant")
Dr Reddy's Laboratories recalls anti-ulcer drug ranitidine from US market
The recall comes after USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine
 "Dr Reddy's Laboratories recalls anti-ulcer drug ranitidine from US market")
Dr Reddy's Labs shines among pharma stocks, wins investor confidence
The Hyderabad-based company is an outlier among large pharmaceutical producers, having seen a jump in its stock price over the previous year
 "Dr Reddy's Labs shines among pharma stocks, wins investor confidence")
Dr Reddy's halts worldwide supply of Ranitidine drug after probe by USFDA
Ranitidine is an Over-The-Counter (OTC) and prescription drug which decreases the amount of acid created by the stomach
 "Dr Reddy's halts worldwide supply of Ranitidine drug after probe by USFDA")
Regulatory worries, price erosion may pull down Dr Reddy's US revenues
Repeat observations for an approved facility are an indication of consistent regulatory challenges for the company, says an analyst with a foreign brokerage
 "Regulatory worries, price erosion may pull down Dr Reddy's US revenues")
Dr Reddy's Labs slumps 8% as US FDA issues CRL for its version of NuvaRing
A CRL is issued when the FDA decides not to approve new or generic drug application for marketing in its present form
Dr Reddy's launches insomnia treatment tablets in US after FDA approval
The product is a generic version of Takeda Pharmaceutical Company's Rozerem tablets in the same strength
Dr Reddy's closes sale of US, select territory rights for neurology drugs
Under the agreement, Dr Reddy's sold its US and select territory rights for Zembrace Symtouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg
 "Dr Reddy's closes sale of US, select territory rights for neurology drugs")
Dr Reddy's Laboratories unveils generic version of Allegra-D in US
Allegra-D 12 HR is a trademark of Aventisub II Inc
Dr Reddy's Laboratories launches generic anti-cancer drug in US market
Gleevec and its generic equivalents saw sales of approximately $868 mn in the US for the last twelve months ending in July 2018
 "Dr Reddy's Laboratories launches generic anti-cancer drug in US market")
