Pharmatech Associates, a USP company’s Post

I am proud to have founded Civica Rx with Dan Liljenquist and even more proud of the team at Civica, which has successfully implemented the following ideas: - Do what is in the best interest of patients! - Civica enters into long-term purchase and supply contracts that add stability to the market. - Civica contracts directly with hospitals, rather than through middlemen that may contribute to price and supply instability. - Civica targets a six-month buffer inventory of every drug to ensure continuity of supply. - Civica emphasizes U.S. sourcing whenever possible, with the European Union and Canada as second choice. Finished drugs or active pharmaceutical ingredients are not sourced from China unless there is no other option. - Civica performs an intensive quality audit of potential suppliers and ongoing reviews of key metrics to maintain adequate supply and reduce the risk of drug shortages. - Every drug is sold on a cost-plus basis, with the same price available to all participating hospitals. Prices remain stable even when the drug is in short supply. - Civica has built a new, state-of-the-art sterile injectable manufacturing facility in Petersburg, Virginia, and is developing its own generic drug applications to further ensure the supply of essential medications. #drugshortages #CivicaRx https://lnkd.in/ePJabCyR

Did you know? The FDA approved 956 generic drug products in 2023. With such a high volume of filings, the FDA is intolerant of incompleteness or lack of clarity. It’s important to know what questions to anticipate, the rigor of data they expect, and how to conduct mock inspections from the FDA’s lens. If you’re pursuing U.S. market entry but intimidated by the FDA approval process, check out our U.S. Market Entry Roadmap to help you navigate the complexities of regulatory compliance, distribution, and commercialization in the U.S. market: https://lnkd.in/gDkGRwYC

Welcome back from our giving thanks holiday last week! Today is a Tuesday Top Up day. I'm highlighting drug pricing. This topic was one of my trends for 2023 announced in my end of year highlights last December. True to expectations, drug pricing has continued to be a high risk impact issue. Why? 1) Inflation Reduction Act regulating prices: * September 1, 2023, CMS published the first 10 Medicare Part D drugs selected for the Medicare Drug Price Negotiation Program. *Coming next: negotiated maximum fair prices for these drugs to be announced by September 1, 2024. Prices in effect starting January 1, 2026. 2) Reformulations Pending: * European Medicines Agency (EMA) proposes ban on use of titanium dioxide (TiO2), a common ingredient in medicines. * Timing: European Commission to make final decision on the ban in February 2025. Could take effect in early 2026. Looking like drug pricing will make the high risk impact topics again this year in my End of Year Post. #biotechnology #pharmaceutical #compliance #riskmanagement #hughesbiopharma

🌍 The Rise of Generic Drugs: A Global Perspective 📈 Did you know? The global sales of generics have been on an upward trend since 2022, and are projected to reach a whopping $68.17 billion by 2029! 💰 Teva currently leads the pack, but Sun Pharma is hot on its heels and expected to take the lead by 2029. 🏆 But wait, there's more! Ever get generics and biosimilars mixed up? You're not alone! While both offer more affordable alternatives to brand-name drugs, they're not the same. Generics are like twins to the reference medicine, with the same active ingredients and treatment outcomes, but at a fraction of the cost. 💊 And here's a fun fact: In the US, 9 out of 10 prescriptions filled are for generic drugs! The FDA approved a whopping 956 generic drug applications in 2023 alone! 📜 Let's celebrate the role of generics in making healthcare more accessible and affordable! 💪 #GenericDrugs #Healthcare #Pharmaceuticals #Biosimilars #Teva #SunPharma #FDA #AffordableMedicine #DrugApproval #CNS #Cardiovascular #GlobalHealth #Medicine #Pharmacy #Biotech #Innovation #CostSaving #PublicHealth #HealthcareCosts #USHealthcare #DrugMarket #PharmaTrends #HealthcareIndustry

The demand for low-cost, high-quality drug offerings in the U.S. is high, with 6.3 billion prescriptions written annually and more than 300 drug shortages each year. This is good news for drug companies pursuing U.S. market entry, but where to start? Check out our U.S. Market Entry Roadmap for a step-by-step guide to strategic planning, regulatory compliance, commercial readiness, and beyond: https://lnkd.in/gDkGRwYC

Compliance only is not enough to enter the U.S. pharma marketplace, a culture focused on quality is just as important. The significance of safety and transparency in the production and distribution of drugs is emphasized by the Drug Quality and Security Act, which also emphasizes the need for strong manufacturing procedures and product tracing systems. https://hubs.ly/Q02zMpTM0

Drug Reporting Requirements to Take Effect Feb. 26 Following Final Guidance: The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s visibility into drug supply chains. #fda #financial #lifesciences

Federal agencies are taking a closer look at the contracting practices and compensation models of group purchasing organizations and drug wholesalers to ascertain their impact on generic drug shortages. Read more in this alert by Austin Ownbey and Tina Papagiannopoulos: https://bit.ly/4bLKcu1

📝 Generic drug shortages have been in the news for several months now, with many stakeholders and interested parties trying to find a solution so that patients don’t have to go without their life-saving treatments. While there have been several different theories floated since the shortages first started appearing, including increased demand and manufacturing quality issues, one interesting concept is that the shortages may be the result of generic drug prices being too low... Read the full article here: https://lnkd.in/gJHd3fXP

Discover global drug prices with Ex-PRICE 🌍  Want to  compare drug prices from around the world? Introducing Ex-PRICE tool, your gateway to a world of drug price insights. With Ex-PRICE, you can:  ✅ Compare drug prices from 50 countries worldwide  ✅ Access to up to 100 foreign databases   ✅ Explore prices from the entire EU, USA, Canada and Russia That’s not all – if there is a specific country you are missing, let us know and we’ll make it happen. ➡️ Request a personalized demo at exprice.eu today to discover all the benefits of our new tool.   Get started today! #Pharmaceuticals #DataAccess #DrugPricing #ExPRICE #Healthcare