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, it feels like a ‘roll-back-the-clock’ moment in which we attempt to deconstruct a measure of drug manufacturing globalization.
As a U.S.-based firm, we’ve heard the calls for a more U.S.-centric supply chain. But it is being felt everywhere – from Brussels and London to New Delhi and Tokyo. The rise of various nationalist approaches to supply chain security seems a foregone conclusion at this point, with many countries encouraging the establishment of domestic capabilities as a hedge against future global uncertainty.
Over the years, we’ve spoken with project managers, Chief Technology & Science Officers, and countless others involved in early stages of small molecule development (pre-clinical, R&D, formulation development, manufacturing, etc.). Supply chain issues always have been on people’s minds. At times, they have risen to the fore as specific challenges emerged, only to again recede as things stabilized and the industry moved on.
COVID-19 may prove to have been our industry’s key domino that brought about sweeping change. It is rare for a single event (albeit a major global pandemic) to cause such a massive shift in thinking so quickly.
Nexgen Acquisition to Strengthen US Presence, Mitigate Risks for Pharma
On July 27, 2020, LGM Pharma acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. This combination brings together LGM Pharma’s global leadership in Active Pharmaceutical Ingredient (API) sourcing, distribution and supply chain management with Nexgen Pharma’s comprehensive drug product contract development and manufacturing (CDMO) services.
The expansion of our domestic facilities in the United States comes at an opportune time, as a variety of supply chain risks threaten US supply chain management. Key among these are geopolitical tensions with China, the COVID-19 pandemic, environmental concerns and an ever-changing regulatory landscape, both in the US and worldwide. [We have discussed supply chain risk mitigation at length in earlier posts. Read: A Look at Reshoring Drug Manufacturing: A Q&A With LGM Pharma’s Hamilton Lenox, Risk Management Practices to Address Pharmaceutical Sourcing Challenges, and Confronting Drug Supply Chain Risks.]
Nexgen Pharma’s capabilities are highly complementary to our core business and expertise. Specializing in the development and manufacture of solid dose, powder, suppository, semi-solid, and liquid drugs, Nexgen has been manufacturing healthcare products with a rigorous commitment to quality and customer satisfaction for decades – providing a comprehensive one-stop manufacturing solution that includes:
- formulation development
- analytical method development
- process validation
- ANDA/NDA regulatory support and submission
- stability studies
- raw material and finished product testing
Expanded US Presence Offers New Capabilities and Solutions
The acquisition brings Nexgen’s manufacturing and warehouse distribution facilities and employees in California and Texas to the LGM Pharma team, along with its formulation development, laboratory, and pilot plant manufacturing employees and facilities in Colorado. In all, LGM Pharma is excited to welcome 150 experienced employees and more than 100,000 ft2 of fully equipped facilities, along with expertise in all aspects of pharmaceutical finished product development and manufacturing.
The combined customer base will gain access to an expanded scope of regulatory services now available at LGM Pharma. These include assisting with CMC requirements and filings, and providing expert support for ANDA and NDA submissions.
All the new facilities are current on inspections and approvals – with no negative reports or observations. Our current FDA CGMP status is VAI (no regulatory or administrative actions pending).
In addition to expanding LGM’s US operations, our Drug Manufacturing Division gives you an alternative API supply and drug manufacturing source that mitigates your risk.
We welcome the opportunity to provide you with an end-to-end solution from a single strategic partner, securing your supply chain and accelerating your new product pathway.
Our deep knowledge of the pharma market and pre-certified partner network enables you to plan for the future, while our expanded geographic diversity of suppliers reduces your risk from geopolitical factors. Partner smart for your API needs and CDMO services. Contact LGM Pharma.