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USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs
Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

Sharan Murugan
Sep 4, 20242 min read
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WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...

Sharan Murugan
Apr 20, 20242 min read
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MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan
Jan 18, 20242 min read
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USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Sharan Murugan
Aug 4, 20232 min read
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Canada HC Guidance: Nitrosamine Impurities in Medications
Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Sharan Murugan
Jul 30, 20231 min read
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Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...

Sharan Murugan
Jul 12, 20231 min read
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Health Canada: Guidance on Nitrosamine Impurities in Medications
Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...

Sharan Murugan
Apr 23, 20231 min read
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UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...

Sharan Murugan
Nov 19, 20221 min read
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Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...

Sharan Murugan
Aug 12, 20221 min read
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