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Lupin gets warning letter from USFDA for Somerset facility
Sun, Jun 13, 2021
Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US. The United States Food and Drug Administration (USFDA) had inspected the company's Somerset, New Jersey, facility from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing
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
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
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.
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.
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
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
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
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
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
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%
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
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
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, 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
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
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
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
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.