The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny

Author:

Nudelman Raphael1ORCID,Kocks Grace2ORCID,Mouton Bruno3ORCID,Ponting David J.2ORCID,Schlingemann Joerg3ORCID,Simon Stephanie3ORCID,Smith Graham F.4ORCID,Teasdale Andrew5ORCID,Werner Anne-Laure2ORCID

Affiliation:

1. Teva Pharmaceutical Industries Ltd., 124 Dvorah Haneviah, Tel Aviv 6944020, Israel

2. Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds LS11 5PS, U.K.

3. Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany

4. Data Science and AI, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge CB4 0WG, United Kingdom

5. Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, United Kingdom

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Reference93 articles.

1. Suspension of ranitidine medicines in the EU. EMA/231394/2020. European Medicines Agency, April 30, 2020. https://www.ema.europa.eu/en/documents/press-release/suspension-ranitidine-medicines-eu_en.pdf (accessed 2023-06-09).

2. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. U.S. Food and Drug Administration, April 1, 2020. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market (accessed 2023-06-09).

3. EMA update on metformin diabetes medicines. EMA/660975/2019. European Medicines Agency, December 6, 2019. https://www.ema.europa.eu/en/documents/press-release/ema-update-metformin-diabetes-medicines_en.pdf (accessed 2023-06-09).

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