हिंदी में पढ़ें

USFDA

Strides Pharma Science receives EIR for Bengaluru facility from USFDA

Strides Pharma Science receives EIR for Bengaluru facility from USFDA

Mon, Mar 30, 2020

"The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids," it added.

USFDA inspection at Aurobindo Pharma's Unit IV

USFDA inspection at Aurobindo Pharma's Unit IV

Fri, Feb 21, 2020

The Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV, from November 4, 2019, to November 13, 2019, is still open and under review

Zydus receives tentative approval from USFDA for Tofacitinib tablets

Zydus receives tentative approval from USFDA for Tofacitinib tablets

Sat, Apr 06, 2019

Tofacitinib is used alone or with other medications to treat moderate to severe forms of rheumatoid arthritis, the company said in a BSE filing.

TRENDING NOW

USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'

USFDA classifies Lupin's Somerset facility as 'Official Action Indicated'

Sun, Mar 17, 2019

Drug major Lupin Saturday said it has been cautioned by the US health regulator that its Somerset (New Jersey) facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.

Aurobindo Pharma to recall 80 lots of blood pressure medicine Valsartan in the U.S.

Aurobindo Pharma to recall 80 lots of blood pressure medicine Valsartan in the U.S.

Thu, Jan 03, 2019

The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.

Pharma sector outlook 2019 in India: Expect big recovery in New Year; IPCA, Divis Lab champions of 2018

Pharma sector outlook 2019 in India: Expect big recovery in New Year; IPCA, Divis Lab champions of 2018

Mon, Dec 31, 2018

The sector has been volatile throughout the year due to constant news flow in the markets. Some giants of the sector witnessed objections over their manufacturing plants and medicine pricing in the U.S. markets.

Torrent Pharma recalls Losartan hypertension tablet in US

Torrent Pharma recalls Losartan hypertension tablet in US

Fri, Dec 21, 2018

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients.

Sun Pharma stock rises over 3% as USFDA inspection starts at Halol plant

Sun Pharma stock rises over 3% as USFDA inspection starts at Halol plant

Mon, Feb 12, 2018

Sun Pharma share is trading over 3% higher at 11.27 am on news that its Halol plant in Gujarat was being inspected by the USFDA upon the invitation by the company. Last month, the facility received clearance from Dutch drug regulator.

HDFC, HDFC Bank, ONGC, Bharti Airtel, Tata Motors, TCS in focus today

HDFC, HDFC Bank, ONGC, Bharti Airtel, Tata Motors, TCS in focus today

Fri, Dec 22, 2017

HDFC has approved the sale of 100% of its equity share capital of HDFC Developers and HDFC Realty to Quikr India for Rs 101.99 cr and Rs254.98 cr, respectively. The stock is trading flat after hitting the day's high of 1715.85 on the NSE.

Sun Pharma shares touch new lows as pricing pressure in US continues

Sun Pharma shares touch new lows as pricing pressure in US continues

Mon, May 29, 2017

Sun Pharma's fourth quarter results have been disappointing. The company said that pricing pressure in its US generic operation will continue for more time. Analysts, in the meantime, have begun downgrading the stock.

Sun Pharma says sales may fall in 2018 as US market gets tougher for generic drugs

Sat, May 27, 2017

Sun Pharmaceutical Industries MD Dilip Shanghvi has said on Friday that the US sales might fall in 2018 because of pressure on drug prices, signalling tough market conditions in the United States (US) for generic drugmakers.

Dr Reddy's Q4 net profit rises by 319%

Dr Reddy's Q4 net profit rises by 319%

Fri, May 12, 2017

GV Prasad, Co-Chairman and CEO of Dr Reddy's Laboratories said, “FY17 has been challenging year due to lack of new product approvals for the US market. However, our other geoghraphies delivered good performance with several new product launches.”

Lupin launches pain relief drug in US; shares rise

Lupin launches pain relief drug in US; shares rise

Thu, Mar 09, 2017

Drug firm Lupin today announced the launch of pain relief drug Hydrocodone Bitartrate and Acetaminophen in the US market.

Wockhardt shares tank over 5% after US drug regulator warning

Wockhardt shares tank over 5% after US drug regulator warning

Thu, Mar 02, 2017

In a BSE filing on Wednesday, Wockhardt said, "The US Food and Drugs Administration (USFDA) has issued a warning letter to Morton Grove Pharmaceuticals, USA, a stepdown subsidiary of the company."

Sun Pharma recalls 2.7 lakh bottles of antidepressant in US

Sun Pharma recalls 2.7 lakh bottles of antidepressant in US

Sun, Feb 05, 2017

The recall is being initiated by Sun Pharmaceutical Industries Inc for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Q3FY17: Dr Reddy's Laboratories' net profit down 19% at Rs 470 crore

Q3FY17: Dr Reddy's Laboratories' net profit down 19% at Rs 470 crore

Sat, Feb 04, 2017

GV Prasad, Co-chairman of Dr Reddy's Laboratories said, "Our performance in Q3 has delivered a modest sequential revenue growth of 3% over the previous quarter. Our EBITDA has improved significantly from the last quarter to Rs 8.8 billion, on the back of enhanced emphasis on operational efficiencies and controlling of SG&A cost across all our business."

Natco Pharma drops as USFDA makes six observations

Natco Pharma drops as USFDA makes six observations

Wed, Jan 25, 2017

Shares of Natco Pharma dropped 0.22% on NSE Nifty after the company said that USFDA conducted an inspection at its pharmaceutical factory in Kothur, near Hyderabad between January 16-24, 2017.

USFDA to re-audit Dr Reddy's three plants in first quarter of 2017

USFDA to re-audit Dr Reddy's three plants in first quarter of 2017

Thu, Jan 12, 2017

US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.

WATCH: Top 5 stories of this evening; From fall in markets on profit booking to Govt appointing Viral Acharya as RBI's new deputy governor

WATCH: Top 5 stories of this evening; From fall in markets on profit booking to Govt appointing Viral Acharya as RBI's new deputy governor

Wed, Dec 28, 2016

Zee Business brings you the most important stories of the day that will help you shape your market strategies and keep you informed with the latest developments.

WATCH: Top 5 stories of this afternoon; From NSE Nifty nearing 8,050-mark to NITI Aayog suggesting 7% custom duty on manufacturing

WATCH: Top 5 stories of this afternoon; From NSE Nifty nearing 8,050-mark to NITI Aayog suggesting 7% custom duty on manufacturing

Wed, Dec 28, 2016

Zee Business brings you the most important stories of the day that will help you shape your market strategies and keep you informed with the latest developments.

Lupin gets USFDA nod for hypertension treatment drug in US

Lupin gets USFDA nod for hypertension treatment drug in US

Mon, Dec 26, 2016

Drug major Lupin has received tentative approval from the US health regulator to sell Olmesartan medoximil tablets, used for treating high blood pressure, in the American market.

Divi's laboratories drops over 10% on USFDA reports

Divi's laboratories drops over 10% on USFDA reports

Mon, Dec 26, 2016

Pharmaceutical major Divi's Laboratories Ltd continued to fall on Monday with the stock cracking over 10%, or Rs 85.75 per share.

USFDA raises concerns of quality control at Sun Pharma's plant

USFDA raises concerns of quality control at Sun Pharma's plant

Tue, Dec 13, 2016

The US regulator has once gain raised concerns of the quality control process at one of its factories.

Load More

LIVE TV

By accepting cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.

x