Adare Pharma Solutions的动态

Starting from July 1st, Dextromethorphan (including its salts and single-ingredient preparations), Nalfurafine (including its salts, isomers, and single-ingredient preparations), and Lorcaserin (including its salts, isomers, and single-ingredient preparations), as well as compound preparations containing Diphenoxylate, will be classified under the Schedule II controlled substances. Midazolam raw materials (including its salts and isomers) and its injectable forms will be reclassified from Schedule II to Schedule I controlled substances. #APIs #Medical #Rawmaterials #Pharma #Medicine #Pharmaceutical

#Biosimilars provide a significant opportunity to expand patient access to essential medicines without sacrificing product quality.?Data shows that when comparing a biosimilar to its FDA-approved reference product, there are no clinically meaningful differences in safety, purity, or potency. Like all biologics, biosimilars are tested in accordance with the Current Good Manufacturing Practice regulations enforced by the FDA. For more information about the quality, safety, and effectiveness of biosimilars, view the new educational resource from FDA and US Pharmacopeia: https://lnkd.in/dPRTAbBR #GlobalBiosimilarWeek

#Biosimilars provide a significant opportunity to expand patient access to essential medicines without sacrificing product quality.?Data shows that when comparing a biosimilar to its FDA-approved reference product, there are no clinically meaningful differences in safety, purity, or potency. Like all biologics, biosimilars are tested in accordance with the Current Good Manufacturing Practice regulations enforced by the FDA. For more information about the quality, safety, and effectiveness of biosimilars, view the new educational resource from FDA and US Pharmacopeia: https://lnkd.in/dPRTAbBR ? #GlobalBiosimilarWeek?

?? Exciting Update for Generic Drug Applicants! Recently, the USFDA released new guidance titled "Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is designed to support generic drug applicants in understanding the nuances of Product-Specific Guidance (PSG) teleconferences and meetings, a critical part of the GDUFA III framework. This initiative aligns with the FDA's Drug Competition Action Plan, which aims to increase access to safe, high-quality, and effective generic drugs, ensuring patients can access the medicines they need. ?? Learn more: https://lnkd.in/g6eyADyh ?? More on the Drug Competition Action Plan: https://lnkd.in/dM8f6ydU #Pharma #FDA #DrugRegulation #GenericDrugs #HealthcareInnovation

We're thrilled to share our latest case study on Nitrosamine impurity analysis conducted by Artixio. In collaboration with a leading pharmaceutical company in the USA, our team at Artixio provided comprehensive support and expertise in identifying and analyzing Nitrosamine impurities in generic drugs. Nitrosamines are potent carcinogens that have recently gained significant attention within the pharmaceutical industry. Our case study delves into the challenges faced by our client and how Artixio's specialized services helped them navigate the complexities of Nitrosamine impurity analysis. From method development to validation and regulatory compliance, our experienced team ensured accurate and reliable results, enabling our client to maintain product quality and safety standards. Read our full case study to discover how Artixio's expertise can support your pharmaceutical endeavors and ensure regulatory compliance in the face of evolving industry standards. https://lnkd.in/gXkrX-S9 #Pharmaceuticals #NitrosamineImpurities #RegulatoryCompliance #CaseStudy #Artixio #PharmaIndustry #DrugSafety #AnalyticalServices #StayCompliant

?????????? ???????????? ???? ???????? ????????; ???????? ???????????? ?????????? ???????????????? National Pharmaceutical Pricing Authority, that regulates the costs of heart stents based on the Wholesale Price Index has allowed the revision of prices of heart stents for 2024. In 2023, Bare Metal Stent per unit was priced at ?10,509.20, while Drug Eluting Stents and Bioresorbable Vascular Scaffold cost ? 38,265.07, based on the WPI at 12.12%. #pharmaceutical #pricing #authority #regulates #costs #heart #stents #WPI #wholesalepriceindex #bioresorbable

Pharmaceutical degradation takes place through? a)Zero-Order b)First-Order c)Higher-Order d)All of the above Read answer in following https://lnkd.in/eVe7jMsg

Examine the increasing health risks associated with counterfeit drugs in Jordan. Our blog discusses the implications for patient safety and the need for robust anti-counterfeit measures in the pharmaceutical industry. Read More ?? https://bit.ly/3WnIXdD . . #JordanPharma #HealthRisks #CounterfeitDrugs #LT

ONE Supply Chain. ONE Outcome. ONE Conference. ALL IN to End Drug Shortages. Join pharmaceutical?supply chain?leaders devoted to ending this global crisis at SummitONE 2024. Register today to create a world where supply is ALL IN for patients. Register at?https://bit.ly/49riyAt #AllIn2024 #SummitONE #Endingdrugshortagestogether

ONE System. ONE Outcome. ONE Conference. ALL IN to End Drug Shortages.?Register today and unite with pharmaceutical?supply chain?leaders devoted to forever ending this global crisis at SummitONE 2024.?Together, we will create a life-saving supply chain for ALL patients. Register now at?https://bit.ly/49riyAt #AllIn2024 #SummitONE #Endingdrugshortagestogether