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Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
fda.gov
July 12, 2021
Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983.
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NPPA allows 50% price hike for ibuprofen, ranitidine, carbamazepine
firstwordpharma
July 06, 2021
India’s pharmaceutical pricing regulator has allowed a one-time price hike of 50% for ibuprofen, ranitidine and carbamazepine, Business Standard reported.
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Ranitidine Banned again after being Removed from the U.S. Market: Will a Chain Reaction be in China?
PharmaSources/Laoxue
May 21, 2020
The Committee for Medicinal Products for Human Use (CHMP) under the EMA has recommended the suspension of all ranitidine drugs in the EU on Apr. 30.
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EMA recommends eight drugs for approval from April meeting
europeanpharmaceuticalreview
May 08, 2020
The EMA’s human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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A Prospect of Ranitidine Market Changes under the Expanding Influence of Genotoxic Impurities
PharmaSources/zhulikou431
April 22, 2020
The U.S. FDA released the FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) on April Fools’ Day to explain the change characteristics of the genotoxic impurities in ranitidine products and request all ranitidine manufacturers to remove su
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US FDA calls for removal of all ranitidine products
expresspharma
April 03, 2020
New studies show NDMA impurity increases in some meds over time, and when stored at higher than room temperature。
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FDA announces one nizatidine and two ranitidine voluntary recalls
europeanpharmaceuticalreview
January 13, 2020
The US Food and Drug Administration (FDA) has announced that two companies are voluntarily recalling batches of ranitidine tablets and one company is voluntarily recalling lots of nizatidine tablets in the US.
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MHRA announces recall of Medley Pharma ranitidine tablets
europeanpharmaceuticalreview
December 23, 2019
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
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FDA Requires Additional Testing of Ranitidine, Nizatidine
americanpharmaceuticalreview
December 10, 2019
Over the past several weeks, the U.S. Food and Drug Association (FDA) has communicated about the detection of an impurity known as N-nitrosodimethylamine (NDMA) in ...
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Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
europeanpharmaceuticalreview
September 27, 2019
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.