Rakesh Dahiya’s Post

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

USFDA inspection with positive VAI to Strides Pharma at Chennai #Alathurfacility #Drugmanufacturing #Globalpharmacompany #GMP #Indiapharmaindustry #IndianpharmacompanyUSFDAapproval #PharmaceuticalGMPcompliance #PharmaceuticalManufacturing #Regulatedmarkets #StridesAlathurUSFDAinspection #StridesPharmaScience #USMarket #USFDA #USFDAInspection #VAIrating #VAIratingmeaning

Welcome connections! ✨ I am thrilled to share this post as a part of my MBA project. I am excited to share recent news from the pharmaceutical industry: FDA Warns of Dosing Errors in Compounded Weight Loss Drugs ‼️ The U.S. Food and Drug Administration (FDA) has recently sounded a serious alarm about the potential dangers of compounded versions of popular weight loss drugs like Novo Nordisk's Wegovy and Ozempic. The agency has received multiple reports of adverse events, some severe enough to require hospitalization, due to dosing errors associated with these compounded medications. - What are the causes? 1. Incorrect Self-Administration: Patients are often confused about the correct dosage when using compounded drugs, leading to accidental overdoses. 2. Healthcare Provider Errors: Even medical professionals can miscalculate dosages when dealing with compounded formulations. 3. Compounding Process Risks: These drugs might contain additional ingredients or variations in the formulation, increasing the chance of medication errors. Overdosing on weight loss drugs can lead to a range of severe side effects, including severe nausea, vomiting and low blood sugar levels To mitigate these risks, the FDA has urged Healthcare providers to prescribe the appropriate syringe size and provide clear instructions to patients on dosage measurement. The compounders are also advised to ensure accurate labeling and patient information is included with the compounded drug. Patients should carefully follow their healthcare provider's instructions and seek immediate medical attention if they experience any adverse reactions. It's essential to prioritize patient safety and rely on FDA-approved formulations whenever possible✅ I would like to thank Vinod K Sharma,Ph.D for guiding and supporting me in this project✨ #weightlossdrugs #FDAwarning #drugcompounding #healthrisks #patientsafety

Necessity of Testing Nitrosamines & NDSRI Impurities in APIs & Drug Products (applicable for all Route of Administration): * Nitrosamine impurities a Mandatory assessment for all Regulatory Markets of Drug Products, Because Nitrosamine impurities are known to be mutagenic and carcinogenic - Even in trace amounts, are highly toxic and mutagenic, capable of damaging DNA, and subsequently increasing the risk of cancer incidence. * According to ICH M7 Guidelines: Nitrosamine impurities are classified as Class 1 known mutagenic * Regulatory authorities for drug control have specified acceptable daily intake limits for various nitrosamine impurities and NDSRIs in APIs and medicinal products. * The recommended limit for total nitrosamines of 0.03 ppm is not more than 26.5 ng/day and is considered acceptable. * FDA has identified Potential seven nitrosamine impurities that theoretically could be present in drug products: NDMA, #NDEA, #NMBA, #NIPEA, #NDIPA, #NDBA and #NMPA. * #NDSRI, which are a subcategory of nitrosamine impurities that share structural similarity to the active pharmaceutical ingredient (API) in drug products, typically lack compound-specific mutagenicity and carcinogenicity data to inform safety assessments. for more information or enquiry contact on pawan@splendidlab.com PAWAN TIWARY CRO SPLENDID LAB PVT. LTD. #Nitroso #impurity #Pharmaceuticals #Parenteral #Biotechnological #API #CRO #CDMO #Generics #Drug #Discovery #Custom #Synthesis #qa #qc #Analytical #Regulatory #Procurement #SCM #R&D #Production #Scientist #USFDA #EuropeanMedicinesAgency #TGA #CDSCO #MHRA #MHLW .

#Newsupdate Biocon received EIR (Establishment inspection report) from FDA for their Greenfield API facility at Vizag, Andhra Pradesh. This now allows them to commence commerical supplies from this facility to US Market. EIR is Based on the Pre-Approval Inspection conducted by agency between 10-14 June 2024. #News #Pharma #Update #Newsupdate #Biocon #Vizag #Andhrapradesh #Andhra #India #API #active #pharmaceuticals #industry #business #US #FDA #commercial #inspection #EIR #Report