Tuesday, November 30, 2021
Home Health USFDA issues import alert on Jubilant Pharmova's Roorkee plant - ET HealthWorld

USFDA issues import alert on Jubilant Pharmova’s Roorkee plant – ET HealthWorld

REUTERS/Dado Ruvic/File Photo

Drug firm Jubilant Pharmova on Thursday said the US health regulator has placed an import alert on its Roorkee-based manufacturing facility, affecting its exports to the American market. The US Food and Drug Administration (USFDA) has taken the action after conducting an inspection of the formulations plant in March this year, the drug maker said in a regulatory filing.

Earlier, the Roorkee facility had received an OAI (Official Action Indicated) from the USFDA in December 2018, followed by a warning letter in March 2019.

The company will engage with the agency to resolve the import alert at the earliest and ensure Current Good Manufacturing Practice (cGMP) compliance, Jubilant Pharmova noted.

The agency has exempted Meclizine tablets, Olanzapine orally disintegrating tablets, Risperidone orally disintegrating tablets, Spironolactone tablets, and Valsartan tablets from the import alert subject to the company meeting a few conditions, it added.

The products that got impacted due to the import alert contributed to less than 3 per cent of FY21 total revenues for the company, the drug firm stated.

Shares of the Noida-based drug firm closed 6.10 per cent down at Rs 705.80 apiece on BSE. MSS DRR DRR

Source link


Exclusive: Ayurvedic home remedies for Dengue, as cases surge in India

New Delhi: There has been a steady rise in the number of Dengue virus cases in India. The country’s Capital Delhi saw a...

Why Omicron spread could be ‘good sign’ for Delta-hit world – ET HealthWorld

NEW DELHI: Health authorities across southern Africa, currently dealing with an outbreak of the Omicron variant, are consistently reporting that the symptoms of...

Missing ‘S’ gene in RT-PCR test can point to Omicron – ET HealthWorld

PUNE: With the emergence of the Omicron variant, public health experts want laboratories to conduct RT-PCR tests in whole for all the three...


Please enter your comment!
Please enter your name here

- Advertisment -stock market course

Most Popular

Omicron coronavirus variant halts Cape Town’s cruise ship tourism

The docking of the Europa passenger liner in Cape Town on Tuesday was meant to be a ribbon-cutting celebration marking the official start...

Omicron Found A Week Earlier Than Thought, This Country Says

<!-- -->The first cases in the Netherlands were previously thought to be from two flights from South Africa.The Hague: Dutch health authorities said...

Shreya Ghoshal’s fans dig up her connection with Parag Agrawal after he becomes new Twitter CEO, see their pics together

Shreya Ghoshal and Twitter's new CEO Parag Agrawal go a long way back. The singer and the Indian-American technology executive have often exchanged...

Up To 6 Hours’ Wait At Delhi Airport In New Rules For Omicron: Sources

<!-- -->Omicron: Chairs that are socially distanced have been placed in long rows for passengers at Delhi airportNew Delhi: Flyers from countries where...

Recent Comments

%d bloggers like this: