Drug approvals are often complex and time-consuming, even for generic versions of approved medications. Some of this complexity is unavoidable for good reasons, especially when it comes to patient safety. Much of the process is specifically designed to minimize the chance that new drugs – or new versions of existing ones – will cause harm.[…]
2 Key Factors to Accelerate Drug Approvals: Expertise and Relationships
blog, Bulk Active Ingredient, Regulatory, Supply Chain Tags: ANDACOVID19drug shortageFDAPAS Dec 29, 2020
LGM Helps Pharma Manage Supply Chain Risks with Added Services Through Nexgen Acquisition
blog, Bulk Active Ingredient, Drug Research & Development API, LGM Pharma, Supply Chain Tags: analytical methods developmentCDMODrug Developmentdrug manufacturingformulations developmentLGM PharmaNexgenpackagingsemi-solidsolid dosesupply chain Nov 02, 2020
COVID-19 has put supply chain risk management practices under the microscope. Coming on the heels of many other, more localized supply issues in the last decade, it has brought about a near-global assessment that supply chains need to be more tightly controlled and redundant – and less dependent on external, at-risk suppliers. In a sense,[…]
Can the U.S. Stop Buying Drugs from China?
blog, Supply Chain Tags: ChinaCOVID-19risk managementsupply chain Oct 04, 2020
The SARS-CoV-2 pandemic has drawn significant attention to just how much US pharmaceutical manufacturers rely on manufacturers outside the United States, both for drug substances and finished dosage drugs. It also has demonstrated the risks associated with global supply chains that are overly reliant on specific regions such as China and India, which may be[…]
A Look at Reshoring Drug Manufacturing: A Q&A With LGM Pharma’s Hamilton Lenox
blog, Supply Chain Tags: ChinaCOVID-19reshoringsupply chain Jun 08, 2020
When SARS-CoV-2 arrived on American shores this Spring, concerns about overextended drug supply chains already were circulating. The issues at hand weren’t new, by any stretch. Environmental, quality and political actions all had impacted drug imports in the last half-dozen years, causing drug shortages and C-suite anxiety. The global pandemic – and the resultant (albeit[…]
Risk Management Practices to Address Pharmaceutical Sourcing Challenges
LGM Pharma, Supply Chain Tags: Drug Developmentpharmaceutical sourcingsupply chain May 03, 2020
It may seem odd to be discussing sourcing challenges considering the overwhelming evidence we now have of what can happen to global (and even local) supply chains when disaster strikes, but while the coronavirus pandemic certainly has put the spotlight on the risks of global supply chains, it by no means created those risks. Indeed,[…]
Increasing Demand for Cold Chain Logistics
blog, LGM Pharma, Supply Chain Tags: cold chainGDP ComplianceGMP Compliancelogisticsregulatory standardsTemperature Controlledtemperature-controlled facilitiestemperature-sensitive productsWarehouse Capabilities Mar 30, 2020
Last month, in a post on supply chain risks, we referenced the growing cold chain logistics trend as one of the many increasing pressures on pharmaceutical supply chains. Cold chain is less an emerging issue and more a rising tide, however. While it isn’t a new practice by any means, its use has historically been[…]
Confronting Drug Supply Chain Risks
blog, LGM Pharma, Supply Chain Tags: cold chaincorona virusDSCSAserializationsupply chain Mar 02, 2020
The current coronavirus epidemic and subsequent shutdown of travel to and from affected areas in China make supply chain risk management a particularly timely topic this month. While the last thirty years have seen us grow increasingly comfortable with extended, global supply chains, these past few years’ (and months’) events have wreaked havoc on the[…]
