|
New NDSRIs limits coming from EMA soon
|
|
2
|
2370
|
January 16, 2023
|
|
Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards"
|
|
0
|
364
|
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
|
1197
|
December 6, 2022
|
|
FDA issued Warning Letter connected to Genetocix Impurities
|
|
0
|
577
|
November 16, 2022
|
|
Health Science Authority Singapore- Update on nitrosamine impurity, Nitroso-STG-19 (also known as NTTP), in sitagliptin products
|
|
2
|
1458
|
November 14, 2022
|
|
Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
|
|
3
|
704
|
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
|
425
|
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
|
418
|
October 26, 2022
|
|
Ranitidine brands withdrawn from NLEM in India
|
|
2
|
424
|
September 15, 2022
|
|
Apotex recalls additional Apo-Acyclovir tablets due to a nitrosamine impurity
|
|
5
|
1158
|
August 7, 2022
|
|
Strides Pharma and Lupin Pharmaceuticals voluntarily recalled the batches/lots of Losartan Potassium tablets in USA due to AZIDO Impurity levels observed to be above acceptable limits
|
|
0
|
263
|
June 16, 2022
|
|
Stress condition in COC impurity
|
|
6
|
766
|
May 24, 2022
|
|
Sandoz recalls 13 lots of Orphenadrine citrate 100 mg ER tablets
|
|
8
|
855
|
May 3, 2022
|
|
ANVISA finally approved new resolution for conrtol of Nitrosamines in Brazil
|
|
0
|
432
|
April 29, 2022
|
|
Voluntary Recall of lots of ACCUPRIL tablets
|
|
1
|
468
|
April 26, 2022
|
|
Recall of lots of Accuretic tablets by Pfizer
|
|
5
|
674
|
April 25, 2022
|
|
Lupin Pharmaceuticals issues nationwide recall of Irbesartan Tablets
|
|
5
|
886
|
March 22, 2022
|
|
Azithromycin - presence of N-Nitrosamines
|
|
8
|
1004
|
March 3, 2022
|
|
Nitrosamines :Authorities Expectations and Typical Mistakes
|
|
0
|
384
|
February 23, 2022
|
|
Nitrosamine impurity in Bumetanide tablets
|
|
2
|
1034
|
February 11, 2022
|
|
FDA recommendations for minimisation of Nitrosamine related Imps through formulation design changes
|
|
0
|
263
|
February 9, 2022
|
|
Metformin Recall mktd by Viona Pharmaceuticals Inc
|
|
4
|
415
|
January 20, 2022
|
|
Https://www.fda.gov/media/154487/download
|
|
0
|
307
|
December 8, 2021
|
|
USP- Approved <1469> Nitrosamines Impurities
|
|
1
|
1358
|
December 6, 2021
|
|
Health Canada - Urgent Public Health needed due Nitrosamine
|
|
1
|
296
|
November 16, 2021
|
|
TGA, Australia Recalls Sartans due to Azide Impurity
|
|
0
|
361
|
October 15, 2021
|
|
Summary of current Nitrosamine Regulatory scenario
|
|
0
|
292
|
October 15, 2021
|
|
FDA alerts to a voluntary recall of varenicline - What do we know?
|
|
17
|
1332
|
September 30, 2021
|
|
So… the Nitrosamines crisis unfolding into judicial consequences
|
|
0
|
303
|
September 13, 2021
|
|
CDER conducts Lab & Clinical studies to evaluate NDMA production from Ingested Ranitidine products
|
|
0
|
242
|
September 8, 2021
|