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USFDA NEWS

Coca-Cola recalls over 10,000 cans of coke due to plastic contamination in US

March 27, 2025 6:26 pm

The coke cans which were recalled by Reyes Coca-Cola Bottling were distributed in the Illinois and Wisconsin states of the United States.

USFDA pulls up Cipla for manufacturing lapses at Pithampur plant

November 22, 2023 8:31 pm

It also pointed out the company's failure to establish and follow appropriate written procedures.

USFDA pulls up Sun Pharma for lapses in Halol plant

January 15, 2023 7:07 am

In a warning letter, the US Food and Drug Administration pointed out various lapses at the Halol plant which produces finished pharmaceutical products.

Why the US is facing a shortage of Adderall, used to treat ADHD

October 15, 2022 10:23 pm

Patients have been dealing with the scarcity since August, with pharmacies in the US finding it increasingly difficult to stock the drug. The shortage comes at a time when there has been a growing demand for Adderall, particularly since Covid-19 struck.

US regulator doubled warnings to Indian drugmakers last year

January 21, 2020 11:46 am

The sanctions may delay about 18 per cent of new products Indian companies were planning to introduce in the US, according to a report Monday from Crisil Ltd, the local unit of S&P Global Ratings.

Indrad unit of Torrent Pharma gets observations from USFDA

October 11, 2019 1:21 am

In April, the US FDA had conducted an inspection of the Indrad facility which manufactures both API (Active Pharma Ingredient) and formulations with an annual capacity of 30 million vials.

We will continue to engage external consultants, Biocon assures USFDA

April 17, 2018 1:54 am

Biocon earned about 22 per cent of its revenues from the US in 2016-17.

USFDA observations: ‘Mosquitoes, gnats in Alkem plant; no quality control unit’

April 13, 2018 2:42 am

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection if investigators find violations of US drug laws.

Glenmark gets tentative FDA approval for Fingolimod capsules

March 20, 2017 1:57 pm

These capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis

Warning letter: USFDA flags ‘serious violations’ at Dr Reddy’s

November 26, 2015 12:57 am

The US Food and Drug Administration was not satisfied despite Dr Reddy's sending responses nine times from December 15, 2014, to September 15, 2015.

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