Page 10 - Dr Reddys
USFDA seeks voluntary action at Dr Reddy's Andhra Pradesh facility
Shares of Dr Reddy's Laboratories on Friday closed 0.55 per cent down on the BSE
 "USFDA seeks voluntary action at Dr Reddy's Andhra Pradesh facility")
Diabetes to be our focus in India, US: Wockhardt's Habil Khorakiwala
Wockhardt is present in emerging markets like Mexico, Brazil with insulins
 "Diabetes to be our focus in India, US: Wockhardt's Habil Khorakiwala")
New launches, regulatory go-ahead key triggers for Dr Reddy's
Sales in the US, its biggest market, accounting for 37 per cent of revenues, were up 8 per cent year-on-year (YoY) and 12 per cent sequentially, led by five new launches
 "New launches, regulatory go-ahead key triggers for Dr Reddy's")
Top headlines: Air India's 100% stake sale; 1,000 frauds in 5 years at UCBs
From government announcing a 100 per cent stake sale in Air India to a new case of Coronavirus in India here are today's top headlines
 "Top headlines: Air India's 100% stake sale; 1,000 frauds in 5 years at UCBs")
Stock recommendation from Prabhudas Lilladher: Buy Dr Reddy's, GAIL
The stock of Dr. Reddy's has been on a gradual rise with positive indicators supporting the momentum and currently has given a breakout above the previous peak of 3,000
 "Stock recommendation from Prabhudas Lilladher: Buy Dr Reddy's, GAIL")
Dr Reddy's falls 5% as rival firm beats Co to US FDA approval for EluRyng
Rival firm Amneal Pharma has received approval for generic birth-control product NuvaRing from the US Food and Drug Administration.
 "Dr Reddy's falls 5% as rival firm beats Co to US FDA approval for EluRyng")
Technical calls by Religare Broking: Buy Dr Reddy's Lab, Ramco Cements
Weekly Technical Recommendations by Religare Broking Ltd.
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 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 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")