“LGM operates as a trusted partner by seeking out optimal source of APIs for clients”

#SpeakPharma with LGM Pharma

2023-12-13

Impressions: 3016

This week, SpeakPharma interviews Selwyn Lustman, Senior Vice President, Global Sourcing and Procurement, LGM Pharma, a tailored active pharmaceutical ingredient (API) and contract development and manufacturing services provider (CDMO) for the full drug product lifecycle. Lustman discusses the kind of regulatory support LGM provides its clients, while also talking about its methodology for selecting the optimum source of APIs for its clients.

Can you briefly take us through the history of LGM Pharma?

We were established in 2005, and since inception we have been on a dedicated mission to excel in the sourcing and distribution of top-tier APIs, offering comprehensive API supply chain solutions spanning R&D to commercialization.

In 2020, LGM Pharma acquired the formulation development and drug product manufacturing business of Nexgen Pharma, Inc. This acquisition merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services.

What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?

The primary challenges associated with API sourcing encompasses quality and regulatory considerations, necessitating the assurance of a material source aligned with the specific quality and regulatory standards applicable to the ultimate dosage product launch.

Efficient supply chain distribution hinges on establishing a collaborative partnership with a manufacturer capable of seamlessly supporting the entire spectrum, from early research and development (R&D) stages to the culmination of full-scale commercialization.

Price considerations also come to the fore, demanding that the chosen manufacturer not only meets but surpasses safety, environmental, and health requirements. Working with a seasoned sourcing partner serves as a proactive measure to mitigate these risks, as such a partner brings forth invaluable expertise to navigate the intricate landscape of regulatory and quality guidelines.

What kind of regulatory support do you provide your clients?

LGM Pharma offers a comprehensive suite of regulatory expertise to its clients, encompassing a spectrum of critical services. This includes evaluation of active substances and the meticulous technical writing and compilation of US Drug Master Files.

Throughout the development process, LGM provides expert regulatory CMC (chemistry, manufacturing and controls) compliance guidance, overseeing the writing and assessment of quality/CMC regulatory documents (Module 2 and 3).

LGM Pharma ensures seamless coordination with clinical trial partners to guarantee eCTD (electronic common technical document) compliance (Module 5) and conducts critical writing and reviews of drug substance and drug product documentation.

LGM’s commitment extends to adherence to Code of Federal Regulations and guidance documents, ensuring the timely approval of new abbreviated new drug applications (ANDAs), amendments, and post-approval changes.

LGM Pharma also exhibits agility in responding to inspection requests (IRs) and commitment resolutions (CRs) prior to due dates, engages in regulatory authority interactions, including serving as a US agent, and conducts regulatory compliance gap analyses with adept issue resolution. Additionally, LGM conducts scientific, regulatory, and due diligence review of regulatory documents and submissions, reinforcing its commitment to regulatory excellence.

LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?

LGM Pharma distinguishes itself from conventional distributors by adopting a unique approach – one that sets it apart in the industry. Unlike distributors aligned with specific API manufacturers, LGM takes on a consultative role, prioritizing the representation of its clients’ interests.

Operating as a trusted advisor, LGM actively seeks out the optimal source of API for clients to serve as their primary drug substance supplier. In contrast to distributors affiliated with particular manufacturers, who inherently advocate for their associated companies, LGM positions itself as an unbiased entity capable of objectively confirming the selection of the best manufacturer. This client-centric approach ensures a discerning and tailored choice in the dynamic landscape of pharmaceutical ingredient sourcing.

What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?

Logistics plays a critical role in API sourcing, influencing the efficiency, reliability, and regulatory compliance of the supply chain. LGM Pharma, as a specialized pharmaceutical ingredient supplier addresses these logistics challenges in the following ways:

- Supply chain management: LGM is involved in managing the end-to-end supply chain, ensuring the timely and secure movement of APIs from manufacturers to clients. This involves coordinating transportation, handling custom clearance, and optimizing inventory levels to prevent disruptions to the supply chain.

- Quality assurance in transportation: Given the sensitivity of pharmaceutical APIs, LGM implements stringent quality assurance measures during transportation to maintain the integrity of the APIs.

- Regulatory compliance: LGM assists clients in navigating the complex regulatory landscape associated with API sourcing. This includes adherence to GMP regulations, compliance with international standards, and ensuring that the transportation and storage of APIs meet regulatory requirements.

- Documentation and record keeping: LGM maintains detailed documentation related to the transportation and handling of APIs, facilitating regulatory audits and compliance checks. Accurate record-keeping is essential for demonstrating compliance with regulatory guidelines.

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Can you briefly take us through the history of LGM Pharma?

What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?

What kind of regulatory support do you provide your clients?

LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?

What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?