Import Alert

The drugs produced at the Baddi unit can now be detained without physical examination.

Divis Vizag unit fails USFDA audit on alleged reluctance to share drug testing data

In its warning letter US FDA clarified that that Divis got two types of import alerts, one is the usual 66-40 import alert that is issued for firms that haven’t met good manufacturing practices and the other 99-32 a rare import alert for firms that refuse or block FDA inspectors to inspect.

How the US regulator's import ban has pushed Divis off its pedestal

The company that earlier maintained a clean regulatory track record failed spectacularly in the US FDA's audit last December.

Here’s what analysts feel about Dr Reddy’s Labs post US FDA observations

Typically, the US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly

Buy, Sell, Hold: Are these stocks present in your portfolio?

Motilal Oswal has initiated coverage with a buy rating and has set a target price at Rs 229.

A message for Indian pharma: Do what you say, say what you do

Over the last decade, “data integrity” has turned out to be the most discussed and perhaps the most dreaded word for the Indian pharmaceutical companies.

FDA Woes: Pharma Companies feel the US FDA heat

The US drug regulator off late, has been a cause of headaches for many domestic pharmaceutical companies. Today, shares of Divis Laboratories tanked 20 percent after an import alert was issued its on Vizag unit. The Dr Reddy's Laboratories shares also hit a 52-week low after the company's Duvvada plant received 13 observations which included repeats from a November, 2015 warning letter.

Divi’s Labs plunges 17% on US FDA import alert on Vizag unit

The US Food and Drug Administration issued the import alert for the company’s Visakhapatnam unit-II, which contributes 60-65 percent to total sales of the firm.

USFDA issues import alert for Divi's Labs Vizag unit

An import alert from the regulator means that products from the facility meant for imports can be refused without a complete physical examination.

USFDA lifts import ban on Sun Pharma's Mohali plant, shares surge 5%

Sun Pharma said the proposed action will clear path for supply approved products from the Mohali faciity to the US market.

Ajanta Pharma gets import ban for selling unapproved drug in US

The import alert falls in the category of 66-41 which relates to marketing or promotion of unapproved products. In this case, Ajanta was found marketing its erectile dysfunction drug Kamarga in United States without proper approvals.

Ipca says remediation completed at two formulation plants

“The third party consultants are regularly visiting our manufacturing units which are under USFDA import alert/warning letter and are assisting us in implementing robust remediation measures in a proper and timely manner,” Ipca said in a clarification to stock exchanges.

Addressing concern raised by USFDA on Ankleshwar unit: Wockhardt

The latest USFDA warning letter to Wockhardt for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat is part of the "same process” of an earlier import alert the company received from the US regulator for the same facility.

Wockhardt up 5% as USFDA excludes Ceftriaxone from import alert

Wockhardt shares rallied nearly 5 percent intraday Tuesday after the US health regulator excluded an antibiotic drug Ceftriaxone sodium from the import alert.

USFDA imposes import alert on few Himalaya Drug Co products

The alert termed "Detention Without Physical Examination of Unapproved New Drugs Promoted in the US" empowers the US Government officials to detain the products at ports.

FDA India scrutiny quality issue, no witch-hunt: Biocon CMD

Rubbishing concerns that the increasing FDA scrutiny of Indian pharma companieswas a case of "irrational clampdown", Biocon CMD Kiran Mazumdar-Shaw told CNBC-TV18 that the US regulator is mandating more stringent norms for companies across the world.

IPCA Labs tanks 9%, gets USFDA import alert for Ratlam unit

Investors offloaded a huge chunk of shares of Ipca Laboratories on Friday. The stock fell nearly 9 percent intraday. The pharmaceutical firm received import alert from US Food and Drug Administration for its Ratlam unit due to violations of standard production practices.

Wockhardt hit by FDA alert on Chikalthana plant

An `import alert' results in the detention without physical examination of drugs from firms that have not met so-called good manufacturing practices, the FDA website says.

Ranbaxy gains 6%; Nomura says buy but lowers target

Nomura says the correction of 30 percent is an opportunity to buy Ranbaxy Labs. The brokerage house has a buy rating on the stock, but cut its target price to Rs 403 from Rs 490 earlier.

'Doubt Ranbaxy claim that Mohali product filings not hit'

The question that needs to be resolved is what exactly is happening in terms of product filing and why is Ranbaxy saying that the product filings have not been impacted, says Vikas Dandekar, India Bureau Chief, PharmAsiaNews.Com.

Wockhardt Q1 net down 15% to Rs 323 cr, sales slightly up

Wockhardt's first quarter consolidated net sales increased marginally to Rs 1,358 crore in April-Juner from Rs 1,341 crore in the year ago quarter.

Wockhardt plunges 10% on US FDA warning letter

The US FDA had earlier imposed an import alert on the company's Waluj plant in Maharashtra in May. UK drug regulator MHRA had this month recalled some medicines from the same plant citing manufacturing deficiencies it had identified.

Wockhardt hits 52-week low on UK import alert

The UK drug regulator has issued an import alert on the company's Waluj plant near Aurangabad, which makes injectables and solid dosages. The US Food and Drug Administration had in May issued a similar import alert.

Hope basmati import alert issue sorted soon: Kohinoor Foods

Gurnam Arora, JT MD, Kohinoor Foods,speaks to CNBC-TV18 about the impact on the export of Basmati rice in the US due to residual pesticides being found in the samples. The US authorities have issued an import alert and a detailed scrutiny of every grain is taking place

US FDA issues import alert on 2 Dabur India facilities

The US FDA import alert means US authorities can detain without physical examination of new drugs promoted in the US. Dabur, however, says it doesn't export products to the US and so doesn't see any impact on its financials.