AACTIVECTIVE PPHARMACEUTICALHARMACEUTICAL IINGREDIENTSNGREDIENTS

Supplying QualitySupplying QualityActive Pharmaceutical Ingredients TodayActive Pharmaceutical Ingredients Today

For Tomorrow’s Innovative Drug TherapiesFor Tomorrow’s Innovative Drug Therapies

COMPANY OVERVIEWCOMPANY OVERVIEW

• Established in 2004Established in 2004

• Headquarters in Nashville, TNHeadquarters in Nashville, TNAdministrative offices in Boca Raton, FLAdministrative offices in Boca Raton, FLAffiliate offices in Israel, India and ChinaAffiliate offices in Israel, India and China

• Privately held, woman-owned small businessPrivately held, woman-owned small business

• 47 employees across 3 continents47 employees across 3 continents

CONSULTATIVE APPROACHCONSULTATIVE APPROACH

At LGM Pharma, we pride ourselves on customizing At LGM Pharma, we pride ourselves on customizing products and services to fit our clients' needs. products and services to fit our clients' needs.

Based on your specific requirements, we can provide cost effective Based on your specific requirements, we can provide cost effective materials for initial research and more complex development work materials for initial research and more complex development work towards product commercialization by providing API’s from top tier towards product commercialization by providing API’s from top tier GMP certified manufacturers who have the necessary regulatory GMP certified manufacturers who have the necessary regulatory credentials and are able to provide technical packages, letters of credentials and are able to provide technical packages, letters of access to filed DMFs and provide complete assistance and access to filed DMFs and provide complete assistance and documentation to support any regulatory filings.documentation to support any regulatory filings.

OUR CUSTOMERSOUR CUSTOMERS

• Academic, Research Foundations & Institutes

• Regulatory Agencies & Government Health AgenciesExamples: US FDA, Health Canada, EDQM, USP

• Biotech Industry, NDDS companies, Life-Science industry

• Large Pharmaceutical Manufacturers in EU and US :Pfizer, DOW, Merck, Glaxo-Smithkline, Novartis, Sanofi-Aventis

• Contract Research & Manufacturing Organizations (CRO’s / CMO’s)

RESEARCH & DEVELOPMENTRESEARCH & DEVELOPMENT

LGM is a leading US supplier of APIs to various R&D and life science companiesLGM is a leading US supplier of APIs to various R&D and life science companies

• Our portfolio of APIs includes a wide range of the rarest GMP APIs, with complete technical & regulatory documentation Our portfolio of APIs includes a wide range of the rarest GMP APIs, with complete technical & regulatory documentation availableavailable

• Full regulatory capabilities from the outset

• Solid knowledge of US pharmaceutical contract manufacturing, formulation and drug delivery companies (Rx)Solid knowledge of US pharmaceutical contract manufacturing, formulation and drug delivery companies (Rx)

• Extensive experience of US and global regulatory requirements for final dosage formulations (IND/NDA/ANDA/505(b)(2) Extensive experience of US and global regulatory requirements for final dosage formulations (IND/NDA/ANDA/505(b)(2) etc..)etc..)

THERAPEUTIC CLASSIFICATIONSTHERAPEUTIC CLASSIFICATIONS

Analgesics Anti-Retrovirals Antipsoriatics Hormonal Agents

Anthracyclines Anti-Ulcerants Antipsychotics Hypocalcemias

Anti-Asthmas Antibacterials Antithrombotics Immunological Agents

Anti-Diabetics Antibiotics Antivirals Immunosuppressants

Anti-Fungals Anticonvulsants Blood Glucose Regulators Monoclonal Antibodies

Anti-Hyperlipodemics Antidementia Agents Blood Products Osteoporosis Products

Anti-Hypertensives Antidepressants Cardiovascular Agents Prostaglandins

Anti-inflammatories Antiemetics Anti-Neoplastics Respiratory Tract Agents

Anti-Migraines Antihyperphosphatemics Gastrointestinal Agents Synthetic Peptides

Anti-Obesity Products Antiparkinson AgentsGliptins, DPP-4 inhibitors

CRAMS CAPABILITIESCRAMS CAPABILITIES

As a preferred outsourcing partner for leading global pharmaceutical & life As a preferred outsourcing partner for leading global pharmaceutical & life science companies, we have the required capability to deliver products and science companies, we have the required capability to deliver products and services across the pharmaceutical value chain.services across the pharmaceutical value chain.

We have been successfully deploying our capabilities and our contract partners' We have been successfully deploying our capabilities and our contract partners' developed IP for cooperation manufacturing.developed IP for cooperation manufacturing.

Our CRAMS partnering proposition includes:

• Dedicated teams and manufacturing lines from initial research samples through full scale cGMP commercial production• Leveraging resident drug discovery experience in multi-therapeutic and multi-lead discovery programs•Providing business flexibility with early phase to proof-of-concept collaboration, enabling contract research and development projects across multiple domains

CRAMS CAPABILITIESCRAMS CAPABILITIES

•Scaling chemical development to a technologically efficient and cost-effective manner through the intelligent use of process optimization and CMC (chemistry, manufacturing and controls) skills•Investing ethical values in our business activities, reflected in important knowledge/IP protection initiatives and building walls to teams working for partner companies and protecting intellectual property•Manufacturing lab-scale, pre-clinical and clinical scale supplies at our approved partner sites•Full custom synthesis capabilities for APIs, advanced intermediates, related compounds, impurities etc..•Broad range of technical skills and capabilities encompassing all routine chemistries and a wide variety of sophisticated modern technologies

Global Affiliate OfficesGlobal Affiliate Offices

•Global sourcing office located in Israel with branch offices in Shenzhen, China and in Mumbai, India

•Personal factory quality audits (GMP / non-GMP) throughout Europe, China and India

•Understanding of the global API manufacturing industry in Europe, China and Understanding of the global API manufacturing industry in Europe, China and India and the regulatory positioning for manufacturing facilities and APIsIndia and the regulatory positioning for manufacturing facilities and APIs

LOGISTIC CAPABILITIESLOGISTIC CAPABILITIESEvery detail from Manufacturing to PackagingEvery detail from Manufacturing to Packaging

to shipping is handled with quality in mind.to shipping is handled with quality in mind.

Accurate Shipment PaperworkAccurate Shipment Paperwork-including all necessary details

Precise Product LabelingPrecise Product Labeling-as per latest GMP & FDA stipulations

Extensive Global Logistics CoverageExtensive Global Logistics Coverage-Global logistic centers in Europe, China & India

-Unique forwarding networks throughout all major cities

LOGISTIC CAPABILITIESLOGISTIC CAPABILITIES

Supply chain management and distribution responsibility. Supply chain management and distribution responsibility.

Due to our logistics experience and relationships with top class forwarding agents worldwide, we are able to offer specialized shipments that are suited for the pharmaceutical products, including any Due to our logistics experience and relationships with top class forwarding agents worldwide, we are able to offer specialized shipments that are suited for the pharmaceutical products, including any particular requirementsparticular requirements

•Room Temperature Warehouses (+15°C / +25°C)•Cool Warehouses (+2°C / +8°C) as well as equipment for -20°C storage•ISO Class 8 Clean Rooms•Custom Bonded Warehouses•Dangerous Goods storage for classes 4.1, 4.2, 4.3, 5.1, 5.2, 6.1, 8, 9•Online Temperature Monitoring (Access on demand)

INTERNATIONAL EXHIBITIONSINTERNATIONAL EXHIBITIONS

• CPhI Worldwide (Europe, China & India)• API Fair (China) and Chemspec (Europe & India)

• Informex, Bio International & DCAT (USA)

Held every year in major global destinations, these events are unrivalled in their ability to bring together every facet of the business

LGM sourcing managers are always present at every international API tradeshow, in order to ensure that LGM clients get the full benefit of cutting edge information on the newest APIs,

innovative technologies and pharmaceutical market trends

QUALITY ASSURANCEQUALITY ASSURANCE Our number one priority is to provide the highest quality pharmaceutical ingredients to our customersOur number one priority is to provide the highest quality pharmaceutical ingredients to our customers

• Proper knowledge of current monograph requirements

• PSD capabilities provided as per client requirementfor any end applications / NDDS etc…

• Expert identification & troubleshooting of any quality / technical / regulatory issues for each individual API

• Personal factory quality audits (GMP / non-GMP) throughout Europe, China and India