ChemLinked’s Post

For two decades, PSM has cautioned against foreign drug importation, emphasizing its impracticality, safety risks, and lack of cost savings. The recent update to Colorado's Canadian drug importation application to the FDA raises significant implementation concerns. Notably, the drug list has dwindled from 112 to a mere 24, with Colorado expressing interest in importing Ozempic from Canada, a move met with resistance due to prior illegal exports. This poses a crucial question: With Canadians opposing such endeavors, who will ultimately supply these drugs to U.S. states? #DrugImportation #HealthPolicy #FDA #Pharmaceuticals #Ozempic #DSCSA

The FDA recently authorized #Florida to directly import #prescription drugs from Canada, where #medication prices are notably lower. Explore how this development might benefit you by delving into our article.

The FDA recently authorized #Florida to directly import #prescription drugs from Canada, where #medication prices are notably lower. Explore how this development might benefit you by delving into our article.

The FDA recently authorized #Florida to directly import #prescription drugs from Canada, where #medication prices are notably lower. Explore how this development might benefit you by delving into our article.

Recently during an inspection from 9th Apr to 17 Apr 2024 USFDA issued a Form 483 with five inspectional observations to Marksans Pharma’s manufacturing facility in Goa. This form is issued at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the food drug and cosmetic act and related acts. However, the company has committed to addressing these observations within the stipulated time. This incident emphasizes the importance of regulatory bodies like the CDSCO in maintaining the quality of drugs in the market. The role of CDSCO is critical in maintaining and improving the quality of drugs in the Indian market. Incidents like this one highlight the need for stringent regulatory oversight to ensure the safety and efficacy of drugs. #FDAINSPECTION #FORM483 #REGULATORYCOMPLIANCE

Is anyone who can help to get the contact person and email/telephone of Drug Regulatory Authority of Pakistan, DRAP? Regarding some Pakistan end users bought falsified sodium lactate solution 60 through certain Chinese trading companies with counterfeit Longmen COA or even tag. Longmen Pharma won't give up any chance to pursue its legal rights.  We have sent Legal Statement to end user to demand it stopping purchasing any sodium lactate solution product with falsified Longmen COA or even tag. Meanwhile, Longmen Pharma's Lawyer Letter has been sent to the relating Chinese trading companies as well. Moreover, Longmen Pharma also prepares to submit these info to DRAP to check if the counterfeit product with falsified Longmen COA affect the common people's life when they use the end user's IV injection. We admit this is a long and hard process, but it is quite worthy for us to do to protect our product and Longmen Brand as well. #pakistan #pakistanbusiness #apis #pharmaceuticals #pharmaceuticalmanufacturing

What is difference between Drugs and Bulk Drugs? In Notification Number 50/2017 at Sr no. 167(A), for availing notification benefit, IGCRD certificate is required for bulk drugs, however some importers were treating bulk drugs as drugs. Guidance is solicited. - Reply By KASTURI SETHI - The Reply = Drug includes bulk drugs and formulations. See the judgement in the case of Balakrishna Pillai Vs. Matha Medicals , (1991) 2 SSC 203 . This an extract from a dictionary. Also see the d... ... ... http://dlvr.it/T0nmhd #Customs #DiscussionForum #TaxLaws #TaxTMI

NOC's for Manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose are granted as per the Guidance Document issued by CDSCO. The above activity was delegated to State licensing Authorities w.e.f. 20th August, 2018 vide letter of F.No.7- 5/2018/Misc./03 4(NOC) dated 2nd August, 2018 Now, it has been decided with the approval of Hon'ble HFM vide Ministry F. No. X.11035/210/2018-DR (Pt) dated 21st June, 2023 that Industry must be facilitated to file fresh applications for NOC for manufacture of unapproved/approved new drug/banned drugs solely for export purpose from15th May, 2024 on online mode through CDSCO Zonal Offices. Accordingly, power delegated to State/UT Licensing Authority stands withdrawn w.e.f. 15th May, 2024 and such NOC's shall be granted by the Head of respective CDSCO Zonal office w.e.f.15th May 2024. Further All State/UT Drugs Controllers are required to handover all NOC's issued from 20th August, 2018 to14th May, 2024 to respective Zonal Offices of CDSCO. Follow us here at NKG Advisory Business & Consulting Services Pvt. Ltd. for more intriguing content on Compliance, Regulatory services, and consulting for D2C brands. visit our website www.nkgabc.com to know more To start your registration process: Email- navraj@nkgabc.com or call 9711197602 #regulatorycompliance #regulatory #Manufacturing #India #regulatory #compliance #regulatory #cdsco #NKGadvisory #insights #Product #Registration #medicine #moc #productregistration #Journey #news #linkedinnews #drugs #Success #Notification #linkedin #public #notice

On March 4, 2024, the Drug Administration of Vietnam (DAV) issued amendments📝 to the annexes of the ASEAN Cosmetic Directive (ACD).   The amendments include the prohibition🚫 of 15 substances as cosmetic ingredients, the establishment of the maximum concentration limits for three cosmetic ingredients, and some other requirements.   Read more details of the amendments at👇 https://lnkd.in/gkXS5dbt #cosmeticingredients #regulatorycompliance #regulatoryupdates

DYK? The General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the registration and regulation of cosmetic products in Peru. What Regulatory requirements does it seek to comply with when launching cosmetics in the Peruvian market? Check out the infographic for a quick overview. https://lnkd.in/dx6WMFcU #Cosmetics #DIGEMID #Peru #RegulatoryAffairs #FreyrSolutions #Marketentry