Usfda

Sun Pharma Gets Clearance For Halol Facility From US Regulator, Shares Jump

Business | NDTV Profit Team | Wednesday June 13, 2018

The US FDA conducted inspection at Sun Pharmaceutical Industries' facility in Halol from February 12 to February 23.

Sun Pharma Shares Surge After US Regulator Accepts Drug Application

Business | Press Trust of India | Wednesday December 27, 2017

Shares of Sun Pharma surged 6.5 per cent on Wednesday after the US health regulator accepted a new drug application (NDA) for dry eye solution filed by the company's wholly-owned subsidiary.

Dr Reddy's gets EIR from USFDA, stock surges over 6%

Business | Press Trust of India | Tuesday December 12, 2017

Following the development, shares of the company opened on a bullish note at Rs 2,306

Glenmark Pharma Receives 7 Observations From US Regulator On Baddi Unit, Shares Fall

Business | NDTV Profit Team | Tuesday November 28, 2017

Glenmark Pharmaceuticals said the Baddi unit contributes approximately 10 per cent of the revenue of US sales.

Zydus Cadila Gets USFDA Nod To Drug That Treats Severe Acne Vulgaris

Business | NDTV Profit Team | Friday November 24, 2017

Zydus Pharmaceuticals has received the final approval from the USFDA to market Minocycline Hydrochloride Extended Release Tablets

Cadila Gets USFDA's Final Nod To Market Ethacrynate Sodium

Business | NDTV Profit Team | Monday November 20, 2017

Cadila Healthcare shares trade (at 11.55 am) at Rs 450.50, 0.93% higher than the previous session's closing on BSE

Cipla Receives USFDA's Final Approval For Generic Dacogen

Business | NDTV Profit Team | Monday November 20, 2017

Cipla has received final approval for its ANDA for Decitabine Injection 50 mg single-use sterile vial from the US FDA

Biocon Stock Jumps As US FDA Issues EIR

Business | NDTV Profit Team | Monday November 20, 2017

Biocon confirms that the US FDA has issued on establishment inspection report in relation to the cGMP (current Good manufacuring practice) inspection of its asceptic drug product facility

Divi's Lab Shares Pare Gains, Trade Flat After US FDA Closes Out Warning Letter

Business | NDTV Profit Team | Friday November 10, 2017

The shares of Divi's Laboratories (Divi's Lab) pared early gains to trade 0.86% higher at Rs 1,018 on BSE at 3.10 pm. The scrip had hit 8% higher

Lupin Shares Tank 17% On USFDA's Warning Letter, Brokerages Give 'Buy' Rating

Business | NDTV Profit Team | Tuesday November 7, 2017

The Lupin shares crashed over 17% to trade at Rs 851 soon after it announced, in a stock filing, that it has received a warning letter issued by the USFDA pertaining to its plants located in Goa and Indore (Pithampur Unit II).

Divi's Lab Shares Close 17% Higher As USFDA's Import Ban Set To Be Lifted From Vizag Plant

Business | NDTV Profit Team | Thursday November 2, 2017

Divi's Laboratories has informed the NSE in a stock exchange filing that the USFDA will soon lift the import Alert 66-40 and will move to close out the warning letter issued to the company's unit-II at Vishakhapatnam.

Natco Pharma Surges 20%, Partner's Drug Gets USFDA Nod

Business | Agencies | Wednesday October 4, 2017

Natco Pharma shares surged on the news. Its shares were locked at upper circuit of Rs 954.35, a jump of 20 per cent.

Dr Reddy's Lab Gets EIR For 2 Facilities, Shares Jump 7%

Business | Press Trust of India | Thursday September 21, 2017

Dr Reddy's Laboratories said it has received zero observations for its custom pharmaceutical services facility, technology development centre, at Miyapur in Hyderabad after audit of the facility by the USFDA.

Lupin Recalls 12,888 Bottles Of Ulcer Drug In US

Business | Press Trust of India | Wednesday September 13, 2017

The reason for the recall is current Good Manufacturing Practise deviations, USFDA said.

Zydus Cadila Gets US Regulator's Nod For Drug, Shares Jump 2%

Business | Press Trust of India | Wednesday August 30, 2017

The company has more than 140 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.