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Zydus Lifesciences gets USFDA nod to produce prostrate cancer drug

Zydus Lifesciences gets USFDA nod to produce prostrate cancer drug

Wed, Oct 02, 2024

Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to produce a generic prostate cancer treatment drug. The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing.

Alembic Pharma gets US health regulator FDA's nod for scalp psoriasis treatment drug

Alembic Pharma gets US health regulator FDA's nod for scalp psoriasis treatment drug

Mon, Aug 26, 2024

Alembic Pharmaceuticals said it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Betamethasone Valerate Foam.

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity

Wed, Aug 21, 2024

Indoco Remedies Ltd has received final approval from the USFDA to market its generic Lofexidine tablets, used in opioid discontinuation treatment. The approval grants Indoco 180 days of Competitive Generic Therapy (CGT) exclusivity.

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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.

Blanket ban on import of Chinese goods not a feasible option: Nirmala Sitharaman

Blanket ban on import of Chinese goods not a feasible option: Nirmala Sitharaman

Sat, Oct 15, 2016

A blanket ban on import of Chinese goods as being demanded by some sections in India is not a feasible option, Commerce Minister Nirmala Sitharaman said on Friday.

Lupin gets USFDA approval for generic Alzheimer treatment capsule

Lupin gets USFDA approval for generic Alzheimer treatment capsule

Thu, Sep 29, 2016

Pharma major Lupin on Thursday said it has received final approval from the US health regulator to market its memantine hydrochloride extended-release capsules, which are used in the treatment of the Alzheimer's disease.

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