|
Reflective Beginnings: We have to be in the driver's seat
|
|
4
|
554
|
January 9, 2024
|
|
๐จโ๐ป Nitrosamines Trends in Google
|
|
0
|
454
|
January 8, 2024
|
|
๐ Happy Holiday and a Nitrosamines-free 2024!
|
|
8
|
814
|
January 7, 2024
|
|
ISP (Chile) announced the voluntary market withdrawal of Atomoxetine DP (40mg & 80mg) due presence of Nitroso-Atomoxetine
|
|
5
|
1466
|
December 14, 2023
|
|
ๅ
ณไบ2023่ฏ็ฉๆ่ดจๆงๅถๅฝ้
ไบคๆตไผ็่ต่ฎฏ
|
|
1
|
482
|
September 29, 2023
|
|
Singapore: HSA issues retail-level recalls for batches of Apo-Amitriptyline and Apo-Acyclovir tablets due to nitrosamine impurity concerns
|
|
0
|
594
|
September 4, 2023
|
|
Apotex Inc. Canada is recalling one lot of APO-Amitriptyline due to presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) above the acceptable limit at the 48-month stability testing timepoint
|
|
15
|
1487
|
September 3, 2023
|
|
Fluoxetin Recall - Austria
|
|
6
|
782
|
July 28, 2023
|
|
European Pharmacopoeia Commission revises position on nitrosamine impurities
|
|
2
|
627
|
July 28, 2023
|
|
๐ง๐ท ANVISA (Brasil) denies registration
|
|
0
|
497
|
July 27, 2023
|
|
๐ Aripiprazole is not approvable since 'major objections' have been identified
|
|
6
|
864
|
July 18, 2023
|
|
๐จ๐ญ Swissmedic creates nitrosamine expert group to coordinate with manufacturers, regulators
|
|
2
|
549
|
July 10, 2023
|
|
Ministry of Food and Drug Safety of the Republic of Korea detected N-Nitroso-Atenolol in atenolol formulation products
|
|
5
|
1180
|
May 7, 2023
|
|
The Great Nitrosamine Audit: how many more drugs will disappear from our shelves?
|
|
2
|
765
|
April 26, 2023
|
|
Nitrosamine in Antabuse
|
|
7
|
1342
|
April 18, 2023
|
|
Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules due to the presence of a NDSRI, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level
|
|
5
|
984
|
March 30, 2023
|
|
N-nitroso-propranolol?
|
|
18
|
2601
|
February 22, 2023
|
|
Phathom Pharmaceuticals, Inc received complete response letter from US FDA for its approved Helicobacter pylori drug products due to presence of N-nitroso-vonoprazan (NVP), nitrosamine impurity
|
|
1
|
839
|
February 10, 2023
|
|
N-nitroso-quinapril
|
|
15
|
2093
|
February 1, 2023
|
|
Merck has discovered that nitrosamine NTTP in its blockbuster diabetes medications arose mostly during storage, as well as during manufacturing and believes it can resolve the problem by the end of the year
|
|
6
|
2110
|
January 23, 2023
|
|
New NDSRIs limits coming from EMA soon
|
|
2
|
2284
|
January 16, 2023
|
|
Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards"
|
|
0
|
360
|
December 13, 2022
|
|
Indian Pharmacopoeia Commission (IPC) has introduced new general chapter on (a) "Elemental Impurities" and (b) nitrosamine in Indian Pharmacopoeia (IP) 2022
|
|
4
|
1087
|
December 6, 2022
|
|
FDA issued Warning Letter connected to Genetocix Impurities
|
|
0
|
556
|
November 16, 2022
|
|
Health Science Authority Singapore- Update on nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), in sitagliptin products
|
|
2
|
1413
|
November 14, 2022
|
|
Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
|
|
3
|
689
|
November 10, 2022
|
|
US FDA's 2020 Nitrosamine Guidance may be updated to provide clarity on specific topics, as appropriate (It will be interesting to see if it would include nitrosamine drug substance-related impurities, NDSRIs ? ?)
|
|
0
|
423
|
November 1, 2022
|
|
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets due to presence of NDSRI, N-Nitroso-Quinapril above the proposed interim limit
|
|
0
|
406
|
October 26, 2022
|
|
Ranitidine brands withdrawn from NLEM in India
|
|
2
|
413
|
September 15, 2022
|
|
Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity
|
|
5
|
1084
|
August 7, 2022
|