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Get up-to-date with India's latest self-declaration requirement for pharmaceuticals and medical device associations, mandated by the Department of Pharmaceuticals. It is set to take effect on 30 June 2024. Discover the latest regulatory updates with ATTOPOLIS https://lnkd.in/dE7-aDZU #RegulatoryUpdate #AttopolisB2B #ArqonGroup #ComplianceUpdate #HealthcareInnovation #India #Pharmaceuticals #MedicalDevices #SelfDeclaration #UCPMP2024

Developing a comprehensive regulatory compliance plan is key to ensuring that biologics, drugs, and medical devices meet industry standards. Here's a look at the steps involved in this process. Connect with us today!

The Third Party Pharma Medicine Manufacturers in Baddi in this region have the required expertise and capacity to manufacture almost all types of pharmaceutical products such as tablets, capsules, syrups, injections, etc. This versatility can enable the organizations to cover a wider market with their products and help fill the market needs in the most efficient way. Similarly, the accessibility of Baddi and effective transport and communication infrastructure help in easy movement and timely transportation of goods. Also, Best Third Party Pharma Manufacturers in Baddi have hefty research and development budgets that allow for unique solutions and formulations. This focus on R&D can help assure businesses are constantly adapting to industry trends and can bring new products to market quickly. https://lnkd.in/dj9FZEVk

Come learn about the combination product regulatory landscape with our own Sujith Kallur M at PDA Japan Conference! Visit our booth #4 and see the various programs and devices that can help meet your subcutaneous drug delivery needs. #PDA #Japan #drugdelivery #subcutaneous #drugdevelopment #needle #injection #injections #biosimilars #noveldrugs #drugs

Samsung Bioepis wants to pause the preliminary injunction a West Virginia federal court issued last week blocking its biosimilar of Regeneron Pharmaceuticals, Inc.’s blockbuster Eylea while Samsung’s appeal plays out, according to court filings. The Samsung Biologics unit revealed its intention in a motion for permission to file the emergency bid under seal, filed Wednesday in the US District Court for the Northern District of West Virginia. Chief Judge Thomas S. Kleeh granted the request Thursday afternoon. Kleeh on June 14 granted Regeneron’s request for an order blocking Samsung’s biosimilar of the age-related macular-degeneration treatment, called SB15 or Opuviz, during a patent-infringement lawsuit. Samsung appealed the decision to the Federal Circuit later the same day. The emergency motion contains information Regeneron considers confidential, Wednesday’s filing said. The motion also includes “competitively sensitive information” about Samsung’s “plans for the manufacture and commercialization of SB15,” Samsung said in an attached supporting brief. Kleeh on June 11 granted Regeneron’s request for a permanent injunction blocking Yesafili, an Eylea biosimilar made by Viatris' Mylan Pharmaceuticals unit and marketed in the US by Biocon. Eylea had US sales of $5.7 billion in 2023, 44% of Regeneron’s revenue and less than the $6.3 billion it had in 2022, according to data compiled by Bloomberg. Click for full coverage.

Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarter! ⚡️The success of the biosimilar business helped spur the parent company to another lucrative quarter as Samsung Biologics topped the 1 trillion mark in South Korean won for the first time at 1.16 trillion ($839 million). ⚡️It was a 37% increase year over year and a 22% boost sequentially. ⭐️The sales surge fueled a profit increase of 71% year over year and 96% sequentially to 434 billion South Korean won ($314 million). #biosimilars https://lnkd.in/ddugGkV3

Industry Event Coming Up! 🔬 💉 ⚕ #FDA #REdI #MedicalIndustry #Regulatory #Event #Biocompatibility #Sterilization #Microbiology #Drugs #Devices #Biologics #MicroBioConsulting

Rico Solutions' specialists bring unmatched expertise, addressing needs in Medical Devices, Cosmetics, Pharmaceuticals, and beyond. Consult with Our Experts #HealthcareExperts #RegulatoryCompliance #MedicalDevices #Cosmetics #Pharmaceuticals #ExpertiseInHealthcare #HealthcareSolutions #ConsultancyServices #RegulatoryExperts #InnovationInHealthcare #TailoredSolutions #QualityAssurance #RegulatoryLeadership #HealthcareInnovations #RegulatoryConsultancy

FrontierView (part of FiscalNote) analysis demonstrates that between 1 January 2024 and 12 September 2024, Turkish Drug Agency TITCK approved marketing authorization for 383 products from 79 different companies. By the end of 2024, TITCK will exceed its 2023 performance when 421 marketing authorizations were processed. Moving forward, in 2025, marketing authorization timelines will see slight improvement, but further improvement will be prevented by budget and personnel shortages. See the insight bite below for more details. #pharmaceuticals #turkiye #turkey https://lnkd.in/erbnb3tx

We are thankful to all the attendees for participating in our webinar, “Strategic Guide for License Transfers in South Korea”. In case you couldn’t attend, you can revisit the session here. Access the archived webinar here. https://lnkd.in/gBvP9C6M #SouthKorea #MedicinalProducts #Pharmaceuticals #Manufacturers #MarketEntry #Freyr #FreeWebinar #Webinar #RegulatoryAffairs