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New Delhi [India], March 9 (ANI/Parijat): Parijat Industries formulation development laboratory in Ambala, Haryana received its accreditation as an "in-house R&D unit" from the Department of Scientific and Industrial Research (DSIR) in February 2023. DSIR is a part of the Ministry of Science and Technology, Government of India, and has a mandate to carry out the activities relating to promotion, development, utilisation, and transfer of indigenous technology. Parijat has been steadily growing its formidable R&D infrastructure. The company today has 7 different laboratories dedicated to every aspect of the agrochemical sector. The labs include an NABL Accredited Chemical and Physical Testing Lab, Plant Protection Lab, Research Farm (R&D -Agri), Formulation Development Lab (DSIR Accredited), Process Development Lab (Ambala), Process Development Lab (Cuddalore) for Technical and Packaging Lab. In response to the recognition, Keshav Anand, CMD- Parijat Industries said ....
A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs By Amol Galande, Ajay Pazhayattil, and Sanjay Sharma Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy 1 that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations. Certain continuous process improvement changes (for example, Patent # WO/2011/124655, improved process for preparing valsartan) were deemed as the root cause for the higher amounts of NDMA observed. The issue has resulted in the largest product recalls in recent history, affecting brand and generic products alike. The outcome is a reminder ....