LGM Pharma DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

LGM Pharma Unveils Enhanced Analytical Testing Services and Expands CDMO Portfolio

22 Mar 2024

// PRESS RELEASE

LGM Pharma Boosts Capabilities with Investment in Analytical Testing & Suppository Manufacturing in Rosenburg, Texas

13 Mar 2024

// BUSINESSWIRE

BioPharma Connections Adds LGM Pharma as a Strategic Client Partner

25 Jul 2023

// ACCESSWIRE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

Contract Pharma 2024

Booth #134

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

1 INTERVIEW #SpeakPharma, 10 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

media
1 INTERVIEW #SpeakPharma
10 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

583 All APIs, 583 Listed APIs

583 All APIs
583 Listed APIs

FINISHED DOSAGE FORMULATIONS

17 FDF Dossiers, 17 FDA Orange Book

17 FDF Dossiers
17 FDA Orange Book

KEY PRODUCTS

Beta Nicotinamide Adenine Dinucleotide, Bupropion Hydrobromide, Bupropion Hydrochloride, Doxorubicin Hydrochloride, Ketamine Hydrochloride, Lidocaine, Lidocaine Hydrochloride, Naltrexone, Naltrexone Hydrochloride, Naltrexone Methobromide, Pilocarpine Hydrochloride, Polidocanol, Salcaprozate Sodium, Sirolimus, Sodium Tetradecyl Sulfate, Sucralfate, Tesamorelin Acetate, Topiramate, Trastuzumab, Trastuzumab Emtansine

SERVICES

Drug Product Manufacturing, Analytical, API & Drug Product Development

pharmaServices
Drug Product Manufacturing
Analytical
- 2 Analytical Testing Services
API & Drug Product Development
- 7 Formulation Development

KEY SERVICES

Contract Manufacturing for Nasal Solution, Contract Manufacturing for Semi-Solids

Contract Manufacturing for Nasal Solution
Contract Manufacturing for Semi-Solids

INSPECTIONS & REGISTRATIONS

18 FDA, 1 GDUFA

inspections
18 FDA
1 GDUFA

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

About

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

CPhI Worldwide, MilanCPhI Worldwide, Milan

Industry Trade Show

Attending

08-10 October, 2024

Fiera Milano, Italy
Contract Pharma 2024Contract Pharma 2024

Industry Trade Show

Booth #134

26-27 September, 2024

Hyatt Regency New Brunswick, NJ
AAPS 2024AAPS 2024

Industry Trade Show

Attending

20-23 October, 2024

Salt Lake City, UT

CONTACT DETAILS

Click the arrow to open the dropdown

Country

U.S.A

Address

6400 Congress Avenue, Suite 1400 Boca Raton, FL 33487

Telephone

+1 8008818210

info@lgmpharma.com

Website

https://lgmpharma.com/

https://www.linkedin.com/company/lgm-pharma/

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

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

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.

Impressions: 2921

CORPORATE CONTENT #SupplierSpotlight

Product List 2023

Open PDF

Upload

Corporate Presentation

Open PDF

Upload

Five Reasons to Outsource API Procurement

Open PDF

Upload

Challenges with Sourcing Pharmaceutical APIs

DCAT Member Company Announcement Forum

Regulatory Considerations for API Sourcing

Risk Mitigation for Supply Chain Challenges

Sourcing Concerns for Smaller Pharma Companies

Supply Chain Logistics Trends

Value of Finding a Capacity Match Early On

DATA COMPILATION #PharmaFlow

CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs.View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines.