Halol

USFDA pulls up Sun Pharma for lapses in Halol plant

New Delhi, Jan 14 The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written..

FDA's warning letter points to cGMP violations at Halol facility: Sun Pharma

The US FDA last week listed the Halol facility in Gujarat under import alert with products manufactured at the unit now subject to refusal of admission in the US market.

Sun Pharma: Strong speciality show, scale-up in clinical trials awaited

Domestic business is witnessing market share gains and expecting better traction as the company’s field force expansion is over

US FDA flags quality lapses at Sun Pharma's Gujarat plant: Report

At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations, the company said, adding that it was preparing a response, which will be submitted to the US pharma regulator within two weeks of business days.

Sun Pharma: Traction in speciality likely to sustain

Sun Pharma's key specialty products, particularly Ilumya (plaque psoriasis) and Cequa (dry eye disease), held up well

Sun Pharma: Sustained traction in speciality to be a re-rating driver

Sun Pharma's India business is expected to gain traction as sub-chronic and acute therapies pick up with the opening up of clinics/OPDs. This is likely to be fully backed by the field force where the expansion has recently been completed

Sun Pharma’s steady India business and US speciality portfolio should help it do well in FY22

What adds to the Sun Pharma's investment case is the prospect for US specialty. The management hopes to achieve EBITDA break-even for a few products next fiscal

Analysts retain buy on Sun Pharma as USFDA clears Mohali, Halol unit resolution key

CLSA says Mohali plant clearance is a significant positive development for the company and shows progress on regulatory issues. Clearance makes a large oral solid dosage site available to de-risk existing sites.

Here are Sanjiv Bhasin's top trading ideas

In an interview to CNBC-TV18's Latha Venkatesh, Sonia Shenoy and Anuj Singhal, Sanjiv Bhasin of IIFL shared his reading and outlook on the market and also gave recommendations on various stocks.

Sun Pharma up 3% as co may shift key products from Halol plant

Halol is an important plant for Sun Pharma and contributed 10-15 percent to its US sales before the factory received a warning letter from the US Food & Drug Administration for violation of manufacturing norms in December 2015.

Nifty on Cloud Nine! 9 stocks with a high margin of safety

With Nifty a whisker away from its lifetime high and valuation touching 21X FY17P and 18X FY18P earnings, the Street looks cautious. Is it time to take money off the table?

USFDA report on Halol unit to be positive in long-term: Sun

Pharma major Sun Pharma has said the US health regulator's audit report on its plant at Halol in Gujarat will have a positive impact on the company in the long-term.

Do not see any urgency to buy Sun Pharma, says Dipan Mehta

In an interview to CNBC-TV18, Dipan Mehta, Member of BSE & NSE shared his readings and outlook on specific stocks and sectors.

Sun Pharma rebounds, Halol unit observations not worrisome

Analysts feel that observations issued for Halol unit are not serious in nature. They are still hopeful of early clearance from the US Food and Drug Administration to Halol unit. According to them, these are largely related to standard operating procedures and not related to data integrity.

Sun Pharma up 2% as USFDA issues 9 observations for Halol unit

Shares of Sun Pharmaceutical Industries gained 2 percent intraday Thursday on short covering after the US health regulator issued nine observations for Halol plant. The recovery in share price may also be on hopes that the company may be able to resolve these issues soon.

Sun Pharma down 6% on 14-page USFDA observations letter to Halol

Healthcare major Sun Pharmaceutical Industries shares plunged more than 6 percent intraday Wednesday on US Food and Drug Administration (USFDA) concerns. According to IIFL, the US health regulator has issued 14-page 483 observations letter after inspection of Sun Pharma's Halol unit in Gujarat.

Sun Pharma falls 7%, sector under pressure on US probe fear

Pharma stocks, especially which have large exposure to United States, saw knee-jerk reaction on Friday after a media report indicated that US prosecutors are undertaking an investigation into the suspected price collusion.

Sun Pharma Q1 net seen at Rs 1894 cr, US sales likely at $598 mn

According to a CNBC-TV18 poll, the drug major is likely to see revenue growth of 20.2 percent at Rs 7876.6 crore in Q1 against Rs 6552.2 crore in year-ago period.

Hero MotoCorp inks 3-year wage agreement with Gurgaon workers

The three-year agreement will be implemented with retrospective effect starting from August 1, 2015 till July 31, 2018. The earlier wage settlement was effective from August 1, 2012 to July 31, 2015.

Sun Pharma falls 6% on weak sales guidance, price pressure woes

The company also said that the pharma major will continue to build speciality business which could impact short term profitability. It also cautioned that it could lose anywhere between 5-10 percent due to pricing pressure and peer consolidation in the US.