Linnea's Vincamine is now CEP certified! ✅ The European Directorate for the Quality of Medicines & Healthcare (EDQM) has issued a CEP certificate for Linnea’s Vincamine product, making Linnea the first company in the world to have a CEP-certified Vincamine extract. To learn more about Linnea's Vincamine and the CEP certification, visit https://lnkd.in/dwcv-SEd To schedule an informative meeting contact sales@linnea.ch #CEP #EDQM #vincamine #API #botanical #extract #GMP #GACP
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11+Myco MS-PREP®: Excellence in multi-mycotoxin analysis. #rbiopharm #rbiopharmrhone #FoodSafety #MycotoxinTesting #MultitoxinAnalysis #MycotoxinAnalysis #MutlitoxinTesting
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11+ Myco MS-PREP®: Excellence in multi-mycotoxin analysis #rbiopharm #rbiopharmrhone #11mycomsprep #FoodSafety #MycotoxinTesting #Multimycotoxinanalysis #TrustedSolution
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Author. Health Coach. Nutritionist. | Supporting lasting weight loss with and without GLP-1 medication.
Commitment to Excellence in Compounded Medications Are you finding it difficult or expensive to get Ozempic/Wegovy or Mounjaro? Our licensed compounding pharmacies prepare high-quality generic versions of these weight loss medications that comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. Our CareGLP network pharmacies adhere to stringent regulatory standards set by: 🔹 State boards of pharmacy 🔹 FDA 🔹 DEA 🔹 USP Convention Quality and safety are paramount. Each batch of compounded semaglutide or tirzepatide undergoes: 🔹 API verification from FDA-registered manufacturers 🔹 Proper storage of API until use 🔹 Aseptic compounding processes 🔹 Independent lab testing for potency, sterility, and endotoxicity 🔹 Detailed tracking with unique lot numbers and Beyond Use Dates (BUDs) This ensures every dose they ship meets the highest standards for your health and well-being. Discover more at https://lnkd.in/eQHhiFHY #glp1 #wegovy #semaglutide #tirzepatide #tirzepatideweightloss #mounjaro #ozempic #ozempicweightloss #mounjaroweightloss #weightlossmedications #weightlossjourney #weightloss #cravings #weightlosstransformation
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**PRESS RELEASE** Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech”, “Kane” or the “Company”) announces that the US Food and Drug Administration (FDA) has eliminated its usage limitation on the Company’s 510(k) cleared revyveTM Antimicrobial Wound Gel (“revyveTM”). Prior to the removal of this restriction, there was a 90 grams/month limit to the amount of revyveTM product that could be administered to patients. This now clears the way for the introduction and extended use of Kane’s revyveTM Antimicrobial Wound Gel Spray which is expected to be filled in spray cans in a higher quantity making it ideal for application on large wounds. “This is yet another important development for Kane as it allows for increased use of the revyveTM product line throughout the standard of care in both prescription and over-the- counter (OTC) channels,” said Marc Edwards, President & CEO. Read the full press article: https://rb.gy/o5w8l2 #biotech #kanebio #biofilm #chronicwounds #wounds #woundcare #medical #medicaldevice #patent #FDAapprovedProduct #woundgel #revyve #distribution
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Loeb Food & Drug Administration partner James Czaban is featured in a recent Citeline Pink Sheet article discussing the potential expansion of the FDA's no-recording rule for in-person meetings. To read the full article and understand what sponsors should consider when recording an FDA meeting before submitting a formal request, click the link below. #FDA #regulatorycompliance #lifesciences
U.S. FDA’s No Recording Meetings Rule Already Appears Flexible | Loeb & Loeb LLP
loeb.com
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SARIA’s depth of knowledge in specialist areas is acknowledged worldwide and has led to the formation of a number of joint enterprises. Working alongside a number of major international companies, SARIA’s partnerships operate at the forefront of the industry to develop and produce new technologies in food and by-product processing. One example is the partnership operation between SARIA and LGI Group, APC GB – specialising in the collection and processing of animal blood. Using a process called fractionation, APC produces haemoglobin for use in the aqua-culture industry; albumen for use in pet foods; and immunoglobin for pharmaceutical use. Find out more: https://bit.ly/3xBCS1B #DisposalChain #AnimalByproduct #Partnerships #Processing #Sustainability
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The FDA issued the revised draft guidance document on Quality Considerations for Topical Ophthalmic Drug Products the guidance discusses certain quality considerations for ophthalmic drug products : - Microbiological considerations. - Approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. - Use of in vitro drug release/dissolution testing as an optional quality control strategy. - Recommendations for design, delivery, and dispensing features of container closure systems (CCSs). - Recommendations for stability studies. This guidance revises the draft guidance issued in October 2023, to add microbiological considerations related to product sterility for all ophthalmic drug products and the prevention of contamination of ophthalmic drug products packaged in multidose containers. This guidance is being distributed for comment purposes only. https://lnkd.in/diwRJZbg
Guidance for Industry
fda.gov
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Pondering the Procal? Check out this week’s KASIC pearl to learn that you should Pay Attention when Using Procalcitonin ➡ https://lnkd.in/gjM_jhWF #AntimicrobialResistance #antimicrobialstewardship #pharmacy #MedEd #NPs #PAs #infectiousdiseases #antibiotics #antibioticresistance #antibioticstewardship
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Did you know that the global market for animal chewables is projected to reach a value of USD $749.11 million by 2030? In recent years, there has been growing awareness around animal health and wellbeing. As drug developers meet the rising demand in tablets and chewables for animals, TriRx Pharmaceutical Services, LLC is committed to delivering excellent CDMO services to help advance oral solid dose (OSD) drugs and other animal health therapeutics to market. Visit our website to see how TriRx is providing reliable, on-time development and manufacturing for the greater hashtag #animalhealth industry: https://lnkd.in/gX2Qs5Ni Statistics provided by a recent report from Virtue Market Research #healthcare #pharmaceutical #lifesciences
TriRx: Shawnee, Kansas
trirx.com
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Pre-filled syringes (PFS) offer drug developers an efficient and accurate drug delivery method for their therapy with many benefits, including: ✅ Reducing dosage inaccuracies ✅ Minimising product waste ✅ Streamlining administration ✅ Improving accessibility ✅ Preventing contamination risks. But, realising the potential of PFS as a delivery system can be challenging, owing to its small size and complex design. In a recent piece with Life Sciences Knowledge Hub, our PFS expert Vincenza Pironti, Ph.D., MBA, Head of Business Development, discusses the strategies Recipharm is using to overcome PFS hurdles and deliver with certainty. Read more here: https://lnkd.in/dzseqAzZ #PrefilledSyringes #DrugDelivery #CDMO
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