Eric Ittah - Consultant Neopharm Labs | Eric Ittah

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Neopharm Labs Inc. - To continuously improve performance and apply technologies to serve our client partnership, while investing in competent personnel and talent, and creating a culture of pride in our work.

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1990 – Neopharm begins operations in Blainville 1996 – Acquired by MDS Pharma Services 2006 – Warnex Acquires Neopharm from MDS

◦Company operates 2 sites (Laval, Blainville) 2011 – Restructuring of both labs into Blainville April 2012 – Warnex Analytical Services division sold to private

investors.

◦New name: Neopharm Labs Inc.

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IT (DAS, infrastructure, hardware, LIMS) : $950 K Instrument Upgrade: GC, HPLC, UPLC, Dissolution,

Light Scattering : $875 K New Service : ICP-MS : $225 K Stability Chambers – Expansion : $250 K Microbiology – Biolog & Others : $50 K Total investment: $2.35 M

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Inspected by the US Food and Drug AdministrationMay 2012

Certified by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) May 2011

Controlled Drugs and substances License April 2012

Audited and qualified by many global pharmaceutical organizations

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Well-established businesses since 1990

Dominant market position in Quebec

Modern facilities FDA and HPFBI compliant Niche in sterility testing Large narcotics vault Walk-in Stability Rooms

Employees 135

Square Footage:•Blainville•Laval

44 00011 000 (ex Warnex)

Certificates of Analysis

1000-1500/mth

HPLC’sUPLC’s

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GC’s 8

AAS 2

ICP-MS 1

Dissolution Apparatus

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Our skilled and competent Chemistry group uses a wide range of methods to test both raw materials and finished products in accordance with compendial procedures including but not limited to:

USP/NF, BP, Ph.Eur, JP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods

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We analyze many types of samples including but not limited to:

◦ Pharmaceutical, veterinary, cosmetics ◦ Finished products: tablets, capsules, liquids, parenterals, otic and

ophthalmic drops, semisolids, creams, gels, shampoos and suppositories

◦ Raw materials: actives, fillers, binders, lubricants, colours and other excipients

◦ Container/packaging components: plastics, glass, foils, bottles, strip packs and cards

◦ In-process products: bulk mixtures of solids or liquids prior to filling into capsules, bottles, vials and syringes, or before compressing into tablets

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Neopharm Labs offers microbiology and sterility testing to help ensure the safety of various products and ingredients including pharmaceuticals, cosmetics, personal care products, vitamins, water, veterinary products, natural health products, etc. All analysis are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia.

Our experienced microbiology team has expertise in a variety of compendial assays, including: ◦ USP/NF◦ AAMI◦ BP/ Ph.Eur◦ JP◦ AOAC◦ AWWA◦ FDA◦ Client supplied methods

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Antibiotic-microbial assays Antimicrobial effectiveness

testing (AET) Microbial limits Bioburden analysis Desinfectant testing Optical microscopy Water testing

Vitamins Bacterial endotoxin test Methods development and

validation Particle size analysis Microbial identification Crystallinity Sterility testing

The following analyses are performed in compliance with cGMP requirements:

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Team led by Malika Madi – 25 years experience in pharmaceutical and bioanalytical method development and validation.

Collective team experience – 60 years HPLC – RP, NP, Ion exchange Detection – UV, DAD, FLD, ELSD, RID, and Conductivity GC – FID, TCD Method dev., Method transfer, Method validation, Cleaning

validation, USP verification, Forced degradation studies, Assays, Impurities, Residual solvents, Formulation stability, Reverse engineering.

Microbiology Validation Team – led by Isabelle Gladu

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Scientific Solutions◦OOS Resolution◦ Available Team for Communication

Validation Stability Programs Narcotic Vaults Full Service Analytical Lab

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Business Development – Eric Ittah◦ Ext.: 364 eittah@neopharm.ca

Business Development – Marie-Josée Lachapelle◦ Ext.: 330 mjlachapelle@neopharm.ca

Customer Service ◦ Ext.: 326, 368 sc@neopharm.ca

Director, Laboratories– Lina Iacobaccio◦ Ext.: 363 liacobaccio@neopharm.ca

Director, Quality Assurance – Nancy Shore ◦ Ext.: 332 nshore@neopharm.ca

President and CEO– Luc Mainville◦ Ext.: 307 lmainville@neopharm.ca

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Neopharm Labs Inc.865 Michele-Bohec Blainville (Quebec)J7C 5J6

www.neopharm.ca

Tel: (450) 435-8864Fax: (450) 435-7595

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