Warning Letter

Indoco Remedies said it is in touch with the regulator regarding matter. "We will work with the USFDA to resolve these issues at the earliest," Indoco added.

Sebi sent 377 warnings to AIFs in FY24 against 20 in the previous year

Warnings pertain to disclosure lapses with private placement documents and not swiftly addressing investor grievances among others.

USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant

"Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health," it stated.

Committed to maintain highest quality, FDA warning letter on Bardez plant won’t impact supplies: Glenmark

The pharma company says it is committed to work with the US FDA to implement necessary corrective measures in the manufacturing facility in Goa.

Lupin: Somerset warning implies regulatory environment may no longer offer relief

In its Indian business, Lupin is expected to remain steady due to a better mix and outperformance in chronic therapies

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.

Impact of FDA warning letter on sales minimal, to reply in 15 days: Indoco Remedies

The company in conference call with analysts said the impact of the warning letter on the revenues is minimal, as the US FDA warning letter doesn't restrict the company from shipping product to the US, though new approvals may get impacted.

Indoco Remedies at 1-year low on USFDA warning letter for Goa facility

The USFDA had inspected company's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa, between August 31 and September 4, 2016 and issued six observations in Form 483.

Indoco Remedies gets USFDA warning letter for its Goa facility

The US FDA had inspected Indoco's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa), from August 31 to September 4, 2016 and issued six observations in Form 483.

Repeat observations on Vizag site spell bad news for Dr.Reddy's

Analysts considered the latest observations as a setback for the company as it dims hopes of new approvals for the US market in the next year.

USFDA asks Wockhardt to assess quality systems across its plants

“You should immediately and comprehensively assess your company‘s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to (US) FDA requirements,” US FDA said.

Dr Reddy's gears up for key USFDA audits in next 2 months: Srcs

Drug maker Dr Reddy‘s Laboratories will be put to a crucial test in the second week of April as the company gears up for major USFDA audits at its facilities in Srikakulam located some 70 kms away from port city of Visakhapatnam.

5 important things about USFDA warning letters, slow resolution

Warning letters resolutions are taking more time than ever before. Only 9 out of 108 warning letters have been sorted taking an average of 500 days. Data for India and China is even bleaker with just one resolution out of the 64 WLs issued in past 52 months, according to Edelweiss report.

Wockhardt tanks 7% on FDA‘s warning letter to US arm

Morton Grove Pharmaceuticals, a subsidiary of the firm, received a warning letter from the US drug regulator. The move is a blow to the company as it struggles with regulatory non-compliance.

Sensex, Nifty could see a strong start; Wockhardt in focus

Positive domestic and global cues could push up the indices in early trade on Thursday; Wockhardt could be on investors‘ radar following a warning letter issued by US FDA for its Illinois plant

Analysts give a thumbs-up to Cadila on resolution of FDA warning

Brokerage firms and analysts tracking the stock welcomed the development and most have raised the target price. To be sure a lot of them were expecting resolution of the warning letter on Moraiya facility in the fourth quarter of FY17.

Cadila gains on resolution of its Moraiya plant warning letter

The company said it did not receive any observations from USFDA for its Moraiya facility, indicating successful resolution of the warning letter and thereby expects major boost to its US business.

USFDA to re-audit three Dr Reddy's plants

US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.

German regulator clears Wockhardt's Ankleshwar plant

The German clearance allows the company to continue its supply of APIs across European Union.

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.

Sun Pharma up 3%; details of warning letter not worrisome

On December 22, the USFDA made public the warning letter which states that inspection 483 mentioned 23 observations. Out of the 23 observations, 10 were related to the injectables facility, 4 were on the oral solids facility, 8 were related to quality control labs and 1 was on warehousing.

Sun Pharma gets warning letter from USFDA over Halol unit

The warning letter follows inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors.

Dr Reddy's Labs: The bull vs bear case

Shares of Dr Reddy's Labs have been on a downward journey over the past two months, amid concerns over a warning letter the company received from the US FDA over some of its plants, and amid some currency headwinds it faces.