LGM Brochure_sm

The API SpecialistsExpert Pharmaceutical Capabilities.Assured cGMP Excellence.

Company Overview

•Establishedin2007

•ISO9001-2008certifiedcompany

•CorporateHeadquarterinNashville, TN

•AdministrativeofficesinBocaRaton,FL

•BusinessDevelopmentUnitin LongIsland,NY

•AffiliateofficesinIndia,China&Israel

•Privatelyheld,woman-owned small business

•47employeesacross3continents

LGMPharmaisaninnovation-drivenAPIcompany,involvedindistributionofqualitycGMPpharmaingredientstoleadingpharmaceuticalcompanies.

Wespecializeinsupplyingourcustomerswitha

widerangeofAPIssupportedbyintegratedtechnical

capabilitiesandaccesstocompleteregulatoryDMF

documentation.OurproductsoriginatefromourAPI

manufacturingpartnersiteswhoareapprovedbythe

leadingregulatoryauthorities,suchastheUS-FDA,

EDQM,TGA,UK-MHRA,PMDAetc.

Ourindustryexperienceenablesustosupport

ourclientsthroughouttheentirepathwayofdrug

development,fromdiscoverythroughcommercial

production.Basedonthescaleandscopeof

developmentprojectswithwhichweareinvolved,

weareabletoprovideourcustomerswithaseasoned

perspectiveandvaluablemarketinsight.

Our Added Value Proposition:

•OurproductportfolioincludesawiderangeofGMPAPIs,withaccesstocompletedocumentationavailableuponrequest(CTD/CEP/DMF/ASMF).

•Weensurefullregulatorydocumentation&completetechnicalcapabilitiesfromtheoutset,backedbyourapprovedmanufacturingpartners.

•Ourmanufacturingpartnersitesarefullyaccreditedandcertifiedbyallmajorregulatoryauthorities(US-FDA,EDQM,TGA,MHRA,PMDA,ANVISA,COFEPRISetc…).

•Solidknowledgeandexperienceworkingwithvariousformulationdevelopmentanddrugdeliverycompanies(DDS).

•WearereadytofacilitatethemoststringentAPIspecificationstowardsyourspecificfinisheddosageforms.

•Extensiveexperiencetowardsproductsubmissionstotheregulatoryauthorities(IND,NDA,ANDA,505(b)(2)etc..).

AtLGMPharma,ourmissionistodeliverpremium

qualityAPIsandoutstandingservicestoourclients.

OurCustomers:

At LGM Pharma, our clients’ needs are our top priority.

Our client base consists of a diverse array of pharmaceutical

companies, including:

•ContractResearch,Development&ManufacturingOrganizations

•SpecialtyPharmaandNDDSCompanies

•R&D&BiotechCompanies

•GenericPharmaCompanies

•ChemicalCatalogCompanies

•OTC&PrivateLabelManufacturers

•Academic&GovernmentLaboratories

•PharmacyCompoundingIndustry

We focus on developing cutting-edge solutions that enable our client to realize significant qualitative and measurable cost and time benefits in the ‘drug discovery to market’ value chain.

Based on the scale and scope of development projects with which we are involved, LGM Pharma is able to provide our customers with a seasoned perspective and valuable insight.

QualityCommitment

When it comes to purchasing your APIs, we believe that

quality is key.

That’s why our number one priority is providing our

customers with the highest quality pharmaceutical

ingredients, originating from manufacturing partners with full

compliance to strict cGMP guidelines and who are inspected

and approved by the leading regulatory authorities, such as

EDQM, TGA, UK-MHRA, PMDA and US-FDA.

Our continuous evaluation towards improved quality

and GMP processes assures you of the highest degree of

confidence in the quality of our products. We work directly

with QA, process engineers, scientists, and IP specialists, in

order to resolve any analytical, quality or regulatory issues.

LGM Pharma is committed to providing fully cGMP compliant APIs, supported by our ISO quality management system with continuous improvement.

ConsultativeApproach

LGM Pharma provides cost effective materials for initial

research and more complex development work towards

product commercialization by providing APIs from top

quality GMP certified manufacturers. Our manufacturing

partners have the necessary regulatory credentials and

are able to provide technical packages, letters of access

(LoAs) to registered DMFs as well as complete assistance &

documentation towards any regulatory filings.

Close collaboration with many world-class cGMP compliant

and EU & US-FDA inspected and approved manufacturers

gives us several key advantages in the scope of knowledge,

expertise, market trends, quality and documentation.

Possessing unparalleled competitive intelligence on API resources and pharma market positioning, we leverage our information resources in order to assist our clients in making the most informed choices regarding primary and secondary API sources.

LGMPharmaCorporateHeadquarters 3200 West End Ave, Suite 500, Nashville, TN 37203Phone. 1-800-881-8210 l Fax. 615-250-9817 l Email. [email protected]

AdministrativeOffice 6400 Congress Ave, Suite #1400, Boca Raton, FL 33487Phone. 561-981-9994 l Fax. 561-892-0580 l Email. [email protected]

BusinessDevelopmentUnit 14 Jerry Lane, Glen Cove, NY 11542Phone. 1-800-881-8210 l Fax. 561-892-0580 l Email. [email protected]

Anti-Asthma / COPDAclidinium Bromide, Bepotastine Besylate, Budesonide, Ciclesonide, Clemastine Fumarate, Fluticasone Propionate, Formoterol Fumarate, Indacaterol Maleate, Levalbuterol Hydrochloride, Mometasone Furoate, Montelukast Sodium, Nedocromil Sodium, Pranlukast, Salmeterol Xinafoate, Tiotropium Bromide, Vilanterol Trifenatate

Anti-Cancer / AntineoplasticAfatinib Dimaleate, Aflibercept, Anastrozole, Axitinib, Azacitidine, Besifloxacin Hydrochloride, Bexarotene, Bicalutamide, Bosutinib, Bortezomib, Cabozantinib Malate, Cabazitaxel, Capecitabine, Carfilzomib, Carmustine, Ceritinib, Clofarabine, Crizotinib, Dabrafenib Mesylate, Dactinomycin, Dasatinib, Doxorubicin Hydrochloride, Enzalutamide, Erlotinib Hydrochloride, Fulvestrant, Gefitinib, Ibrutinib, Idarubicin Hydrochloride, Imatinib Mesylate, Ixabepilone, Lapatinib Ditosylate, Lenalidomide, Nelarabine, Nilotinib Hydrochloride, Pazopanib Hydrochloride, Pemetrexed Disodium, Ponatinib Hydrochloride, Regorafenib, Romidepsin, Ruxolitinib Phosphate, Sorafenib Tosylate, Sunitinib Malate, Temozolomide, Vandetanib, Vatalanib Succinate, Vemurafenib, Vismodegib

Anticonvulsants (Anti-Epileptics)Brivaracetam, Eslicarbazepine Acetate, Gabapentin, Gabapentin Enacarbil, Levetiracetam, Oxcarbazepine, Retigabine, Rufinamide, Tiagabine, Topiramate, Vigabatrin

AntidepressantsCitalopram Hydrobromide, Bupropion Hydrochloride, Desvenlafaxine, Duloxetine Hydrochloride, Escitalopram Oxalate, Fluvoxamine Maleate, Fluoxetine Hydrochloride, Paroxetine Hydrochloride, Sertraline Hydrochloride, Trazodone Hydrochloride, Venlafaxine Hydrochloride

Anti-Diabetics Alogliptin Benzoate, Canagliflozin, Dapagliflozin, Linagliptin, Nateglinide, Omarigliptin, Repaglinide, Saxagliptin Hydrochloride, Sitagliptin Phosphate, Trelagliptin Succinate, Vildagliptin

Anti-Emetics Aprepitant, Dolasetron Mesylate, Fosaprepitant Dimeglumine, Granisetron Hydrochloride, Ondansetron Hydrochloride, Palonosetron Hydrochloride, Ramosetron Hydrochloride, Tropisetron Hydrochloride

Anti-Fungals Anidulafungin, Caspofungin Acetate, Efinaconazole, Ketoconazole, Luliconazole, Micafungin, Posaconazole, Tioconazole, Voriconazole

Anti-HyperlipidemicsAtorvastatin Calcium, Colesevelam Hydrochloride, Colestipol Hydrochloride, Ezetimibe, Fenofibrate, Fluvastatin Sodium, Pitavastatin Calcium, Pravastatin Sodium, Rosuvastatin Calcium

Anti-HypertensivesAmlodipine Besylate, Aliskiren Hemifumarate, Azilsartan Medoxomil, Benazepril Hydrochloride, Candesartan Cilexetil, Cilazapril, Clevidipine Butyrate, Felodipine, Fosinopril Sodium, Lercanidipine Hydrochloride, Moexipril Hydrochloride, Olmesartan Medoxomil, Perindopril Erbumine, Telmisartan, Trandolapril

Anti-MigrainesAlmotriptan Malate, Eletriptan Hydrobromide, Frovatriptan Succinate, Naratriptan Hydrochloride, Rizatriptan Benzoate, Sumatriptan Succinate, Zolmitriptan

API List

LGM can provide the following APIs listed by their therapeutic classifications, along with CMC/TDP/DMF documentation and complete cGMP capabilities.

We continuously endeavor to provide our clients with the newest APIs for ongoing research, development & product commercialization.

Anti-ParkinsonsApomorphine Hydrochloride, Cabergoline, Clonidine Hydrochloride, Entacapone, Pramipexole DiHydrochloride, Rasagiline Mesylate, Ropinirole Hydrochloride, Rotigotine Hydrochloride, Tolcapone

Anti-ThromboticsAbciximab, Apixaban, Argatroban, Bivalirudin, Dabigatran Etexilate, Edoxaban Tosilate, Enoxaparin Sodium, Fondaparinux Sodium, Prasugrel, Ramatroban, Rivaroxaban, Ticagrelor

AntibioticsBesifloxacin Hydrochloride, Daptomycin, Doripenem, Ertapenem Sodium, Fidaxomicin, Gemifloxacin Mesylate, Linezolid, Lomefloxacin Hydrochloride, Moxifloxacin Hydrochloride, Tedizolid Phosphate, Telithromycin, Ticarcillin Disodium, Tigecycline

AntihistamineAlcaftadine, Azelastine Hydrochloride, Desloratadine, Epinastine Hydrochloride, Fexofenadine Hydrochloride, Levocabastine Hydrochloride, Levocetirizine Hydrochloride, Olopatadine Hydrochloride, Rupatadine Fumarate

Antiretroviral / Anti-HIVAtazanavir Sulfate, Boceprevir, Darunavir Ethanolate, Decitabine, Efavirenz, Elvitegravir, Enfuvirtide, Etravirine, Filgrastim, Fosamprenavir Calcium, Maraviroc, Nelfinavir Mesylate, Nevirapine, Raltegravir Potassium, Rilpivirine, Ritonavir, Tipranavir Disodium

Contrast AgentsDiatrizoic Acid, Gadobenate Dimeglumine, Gadobutrol, Gadodiamide, Gadopentetate Monomeglumine, Gadopentetic Acid, Gadoterate Meglumine, Iohexol, Iomeprol, Iopamidol, Iopromide, Iodixanol

Erectile Dysfunction (ED)Alprostadil, Avanafil, Sildenafil Citrate, Tadalafil, Vardenafil Hydrochloride

ImmunosuppressantsEverolimus, Fingolimod Hydrochloride, Pimecrolimus, Sirolimus, Temsirolimus, Teriflunomide, Tofacitinib Citrate

Monoclonal Antibodies (mAbs)Abciximab, Adalimumab, Alemtuzumab, Basiliximab, Belimumab, Bevacizumab, Brentuximab vedotin, Canakinumab, Certolizumab pegol, Cetuximab, Daclizumab, Denosumab, Eculizumab, Efalizumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab Tiuxetan, Infliximab, Ipilimumab, Muromonab-CD3, Natalizumab, Ofatumumab, Omalizumab, Palivizumab, Panitumumab, Pertuzumab, Ranibizumab, Rituximab, Tocilizumab, Tositumomab, Trastuzumab, Ustekinumab

ProstaglandinsBimatoprost, Beraprost Sodium, Carboprost Tromethamine, Dinoprost Tromethamine, Epoprostenol Sodium, Iloprost, Lubiprostone, Tafluprost, Travoprost, Treprostinil Sodium

Synthetic PeptidesBivalirudin, Cetrorelix Acetate, Deslorelin Acetate, Desmopressin Acetate, Enfuvirtide, Eptifibatide, Exenatide, Ganirelix Acetate, Gonadorelin Acetate, Goserelin Acetate, Histrelin Acetate, Icatibant Acetate, Lanreotide Acetate, Linaclotide, Liraglutide, Leuprolide Acetate, Octreotide Acetate, Oxytocin, Pramlintide Acetate, Teriparatide Acetate, Terlipressin Acetate, Tetracosactide, Triptorelin Acetate

Products covered by valid patents are not offered or supplied for commercial use. Products currently covered by valid US Patents are offered for laboratory R&D use in accordance with 35 USC 271(e)+A13(1).

Any patent infringement and resulting liability is solely at buyer risk.

LGMPharmaCorporate Headquarters 3200 West End Ave, Suite 500, Nashville, TN 37203Phone. 1-800-881-8210 l Fax. 615-250-9817 l Email. [email protected]

Administrative Office 6400 Congress Ave, Suite #1400, Boca Raton, FL 33487Phone. 561-981-9994 l Fax. 561-892-0580 l Email. [email protected]

Business Development Unit 14 Jerry Lane, Glen Cove, NY 11542Phone. 1-800-881-8210 l Fax. 561-892-0580 l Email. [email protected]

Close collaboration with many

world-class cGMP compliant

and EU & US-FDA inspected

and approved manufacturers

gives us several key advantages

in the area of knowledge,

expertise, market trends,

quality and documentation.

See list of newly a p p r o v e d A P I ’s , samples are readily available for your R&D requirements:

• Aclidinium Bromide• Afatinib • Aflibercept • Albiglutide • Alectinib • Apremilast • Avanafil • Belinostat• Boceprevir• Bosutinib • Brexpiprazole• Brivaracetam• Cabozantinib • Cangrelor• Carfilzomib • Ceritinib• Cobicistat• Cobimetinib• Dabrafenib • Daclatasvir• Dalbavancin• Daratumumab • Dasabuvir• Dolutegravir• Droxidopa

• Dulaglutide• Edoxaban• Efinaconazole• Elbasvir • Eliglustat • Elvitegravir• Empagliflozin• Enzalutamide • Evolocumab • Fidaxomicin • Filgrastim • Flibanserin• Gabapentin Enacarbil • Grazoprevir• Glucarpidase • Ibrutinib • Icatibant • Icosapent ethyl ester • Idelalisib• Indacaterol Maleate• Isavuconazole• Ivabradine• Ivacaftor• Ledipasvir• Lenalidomide

• Lenvatinib• Lesinurad• Levomilnacipran • Linaclotide • Luliconazole • Lumacaftor• Macitentan • Mepesuccinate• Miltefosine• Mirabegron • Naloxegol • Nintedanib• Obeticholic Acid• Olaparib• Olodaterol• Omacetaxine• Omarigliptin• Oritavancin• Palbociclib• Panobinostat• Pasireotide • Pazopanib • Pembrolizumab• Peramivir • Perampanel

• Pertuzumab • Pirfenidone• Pleconaril • Pomalidomide • Ramucirumab • Regorafenib • Riociguat • Rolapitant • Sacubitril• Sugammadex• Suvorexant• Tasimelteon• Tavaborole• Tedizolid Phosphate• Telavancin • Tenofovir Alafenamide• Teriflunomide • Tofacitinib • Trametinib • Vemurafenib • Vilanterol • Vilazodone HCl • Vismodegib• Vorapaxar

Pipeline Products List

Products covered by valid patents are not offered or supplied for commercial use. Products currently covered by valid US Patents are offered for laboratory R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.




LGM Pharma is enhancing its position as an active and leading supplier of newly approved APIs, coupled with possibilities for full technical assistance & complete regulatory support.

Specialty Portfolio

Aripiprazole

Atomoxetine

Epinephrine

Escitalopram

Exenatide

Insulin

Meclizine

Meloxicam

Montelukast

Ondansetron

Oxytocin

Riluzole

Rizatriptan

Sildenafil

Sumatriptan

Tadalafil

Vardenafil

Zolmitriptan

Sublingual

Aclidinium Bromide

Beclomethasone Dipropionate

Budesonide

Flunisolide

Fluticasone Furoate

Fluticasone Propionate

Formoterol Fumarate

Iloprost

Indacaterol

Indacaterol Maleate

Leavlbuterol

Mometasone Furoate

Nedocromil Sodium

Salmeterol Xinafoate

Tiotropium Bromide

Triamcinolone Acetonide

Umeclidinum Bromide

Vilanterol

Inhalation

Azelastine HCl

Azithromycin

Besifloxacin HCl

Bimatoprost

Cyclosporine

Dexamethasone Valerate

Difluprednate

Dorzolamide HCl

Epinastine HCl

Fluocinolone Acetonide

Fluoromethalone

Latanoprost

Levocabastine HCl

Moxifloxacin HCl

Olopatadine HCl

Tacrloimus

Timolol Maleate

Tafluprost

Travoprost

Ophthalmic

Agomelatine

Amlodipine

Clonidine

Diclofenac

Donepezil

Granisetron

Imiquimod

Memantine

Olanzapine

Oxybutynin

Palonosetron

Pramipexole

Rasagiline

Rivastigmine

Rotigotine

Scopolamine

Selegiline

Transdermal

Injectable Portfolio

Products covered by valid patents are not offered or supplied for commercial use. Products currently covered by valid US Patents are offered for laboratory R&D use in accordance with 35 USC 271(e)+A13(1).

Any patent infringement and resulting liability is solely at buyer risk.

AbciximabAdalimumabAfliberceptAlbiglutideAnakinraAnidulafunginArgatrobanAtosiban AcetateAtracurium BromideAzacitidineBeraprost SodiumBevacizumabBivalirudinBortezomibCabazitaxelCalcitriolCarboprost TrometamolCarfilzomibCarmustineCaspofunginCetrorelixCetuximabCisatracurium BesylateClofarabineCyclosporinDactinomycinDalbavancinDeforolimusDesmopressin AcetateDinoprost TromethamineDolasetron Mesylate

DoripenemDoxercalciferolEnfuvirtideEnoxaprin SodiumEptifibatideErtapenemEtanerceptExenatideFulvestrantFondaparinux SodiumFosaprepitantGemifloxacin MesylateGlucarpidaseGranisetron IcatibantIdarubicin HClIxabepilone LanreotideLeuprorelin AcetateLinezolidLiraglutide MicafunginMitomycinMoxifloxacin HClMycophenolate MofetilNelarabineOctreotide AcetateOmacetaxine MepesuccinateOndansetronPaliperidone PalmitatePalonosetron

Pamidronic AcidPancuronium BromideParicalcitolPemetrexed DisodiumPeramivirPertuzumabPramlintideRaltitrexedRamosetronRisperidoneRituximabRocuronium BromideRolapitantRomidepsinTacrolimusTedizolid PhosphateTelavancinTemsirolimusTeriparatideTerlipressinTicarcillin DisodiumTigecyclineTrastuzumabTreprostinil SodiumTriptorelinTropisetronValrubicinVecuronium BromideVoriconazoleZoledronic Acid

Injectables




LGM Pharma is committed to be a customer-focused innovative organization providingourcustomerswith

enhancedvaluethrough

partnershipsindiscovery,research,

development,commercialization,

IPR,regulatorycapabilitiesand

integratedsupplychainforthe

globalpharmaceuticalmarkets.

Corporate Headquarters3200WestEndAve,Suite500,Nashville,TN37203,USAPhone:1-(800)-881-8210lFax:1-(615)-250-9817Email:[email protected]

Marketing & Administration Office6400CongressAve,Suite1400,BocaRaton,FL33487,USAPhone:1-(561)-981-9994lFax:1-(561)-892-0580Email:[email protected]

Procurement & Logistics OfficeHamelachaStreet15,IndustrialParkHarTuvABeitShemesh9905515,IsraelPhone:+972-2992-9933lFax:+972-2992-9955Email:[email protected]

Business Development Unit14JerryLaneGlenCove,NY11542,USAPhone:1-(800)-881-8210lFax:1-(561)-892-0580Email:[email protected]

Documents

LGM Brochure_sm