Chemagis catalog

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CHEMAGIS EXCELs IN -

CHEMISTRY BETWEEN PEOPLE AND ITS TRANSLATION INTO LONG-TERM TRUSTFUL RELATIONSHIPS

THE SCIENCE OF CHEMISTRY AND ITS APPLICATION IN THE PHARMACEUTICAL WORLD

T R A N S F O R M I N G C H E M I S T R Y I N T O N E W A N D E X C I T I N G P O S S I B I L I T I E S






bull bull bull ABOUT US

Founded in 1987 Chemagis Ltd is a subsidiary of Perrigo Israel (PIL) Israelrsquos second largest pharmaceutical conglomerate and part of the Perrigo Group ndash the worldrsquos largest manufacturer of over-the-counter pharmaceutical and nutritional products for the store-brand market

Chemagis develops produces and markets an extensive line of high-quality Active Pharmaceutical Ingredients (APIrsquos) and Finished Dosage Forms (FDF) for the branded and generic pharmaceutical industries We offer our customers comprehensive customized packages consisting of IP assets API products dossiers FDF and P-IV partnerships ndash all complemented by strategic alliances Chemagis combines exceptional RampD amp IP capabilities with the highest manufacturing standards including full cGMP ICH and WHO compliance approved by the FDA KFDA and certified by the Israeli Ministry of Health

Chemagis specializes in tailor-made Research and Process Development of APIrsquos propelled by a team of experts and creative scientists and provides solutions to meet individual requirements regardless of complexityChemagis also offers complete technical and regulatory support from project inception through final production Applying high efficiency and control measures during the entire supply development and manufacturing chain and throughout the product lifecycle Chemagis provides outstanding value to hundreds of customers worldwide

Chemagis has been proactively searching for ways to preserve and improve its global leading position and recently has acquired an 85 stake in Vedant an API manufacturing facility located approximately 30 miles

outside of Mumbai The plant has been built to cGMP guideline compliance and is in the final stages of construction When completed and fully operational it will produce Chemagisrsquo current high volume API products along with those targeted for the future

This strategic move will improve Chemagisrsquo operational flexibility and competitive edge Moreover it will increase the level of service while maintaining our high standards of quality and customer support

The driving force behind Chemagisrsquo success has always been the uncompromising quality of service at every stage from advanced RampD and manufacturing procedures through worldwide marketing and long-term customer service

Chemagis has established a presence in the ethical arena particularly in the Drug Delivery Systems market Chemagis offers companies an innovative approach to problem solving creativity and timeliness Addressing both new molecular entities and marketed APIrsquos we providebull Full support through the development stagebull Preparation of drug master filesbull Assistance throughout the approval processbull Full-scale production

AFTER TIME AFTER TIME AFTER TIME AFTER TIMEUSASales amp Marketing

MexicoSales amp Marketing


GermanyProductionSales amp Marketing

IsraelRampDProductionSales amp Marketing

IndiaProduction

ChinaProduction

ChemAgis Operations ChemAgis Markets


AFTER TIME AFTER TIME AFTER TIME AFTER TIMEbull bull bull Why Us

We take it personallyChemAgis believes in chemistry between people We value

open communication with our customers as a critical

catalytic factor ndash improving the accuracy efficiency and

outcome of each project

Client-focused organizationClient focus means an attentive approach to project

definition continuous communication throughout

development and expert follow-up amp support until final

product approval

Generic products ndash Specific solutionsAt the bottom line - our wide range of capabilities and

extensive experience allows us to optimize our offering to

the unique specificities of the customer and the project

From RampD to IPA strong multidisciplinary RampD team coupled with state-

of-the-art facilities results in extraordinary development amp

IP capabilities

Quality-focused organizationQA is an integral part of our entire process rather than a

final step

The incorporation of QA steps early on in the development

and production processes allows us to maintain

consistently high quality without having to sacrifice

throughput

Take part in a true partnershipIn ChemAgis we believe that combining trust flexibility

and a touch of courage fosters truly beneficial

partnerships

Our innovative risk-reward approach to early patent

challenges allows us and our clients to explore possibilities

that would otherwise be irrelevant to both

We invite you to challenge us hellipIn ChemAgis we apply innovation amp flexibility not only in

production and RampD but also in our business models

We invite our clients to develop new business models with us

for the benefit of both parties

ChemAgis offers a wide range of products with special expertise in complex differentiated APIs Control over all major API characteristics including morphology particle size salt type genotoxic impurity amp more

bull bull bull PRODUCT LIST

ACTIVE PHARMACEUTICAL INGREDIENTS

API Name Therapeutic Use

bull Anastrozole bull non-steroidal aromatase inhibitor

bull Azacitidine bull anti-neoplastic anti metabolite agent

bull Cisatracurium Besylate bull neuromuscular blocker

bull Cetirizine Dihydrochloride bull non-sedative anti-histamine

bull Cilostazol bull anti-thrombotic

bull Donepezil Hydrochloride bull anti-alzheimer cognition enhancer

bull Exemestane bull steroidal aromatase inhibitor

bull Fenofibrate bull anti-hyperlipoproteinemic

bull Flumazenil bull benzodiazepine antagonist

bull Fluticasone Propionate bull anti-inflammatory anti-allergic agent

bull Gemcitabine Hydrochloride bull anti-metabolite anti-neoplastic

bull Granisetron Hydrochloride bull anti-nauseant anti-emetic agent

bull Granisetron Base bull anti-nauseant anti-emetic agent

bull Halobetasol propionate bull anti-inflammatory

bull Imiquimod bull immune response modifier

bull Lamotrigine bull anti-epileptic

bull Letrozole bull non-steroidal aromatase inhibitor

bull Levocetirizine Dihydrochloride bull non-sedative anti-histamine

bull Midazolam HCL bull CNS depressant anesthetic sleeping aid

bull Midazolam Maleate bull CNS depressant anesthetic sleeping aid

bull Midazolam Base bull CNS depressant anesthetic sleeping aid

bull Modafinil bull anti-narcoleptic

bull Mometasone Furoate bull anti-inflammatory

bull Moxonidine bull anti-hypertensive

bull Pentoxifylline bull vasodilator

bull Pramipexole Dihydrochloride bull anti-parkinsonian

bull Pramipexole Base bull anti-parkinsonian

bull Rocuronium Bromide bull neuromuscular blocker

bull Temozolomide bull anti-neoplastic alkylating agent

bull Terbinafine Hydrochloride bull anti-dermatophyte (nail fungal infection)

bull Terbinafine Base bull anti-dermatophyte (nail fungal infection)

bull Tioconazole bull anti fungal

bull Tramadol Hydrochloride bull analgesic

bull Zonisamide bull anti-epileptic

Products under patent are not sold until patent expiration in the relevant country

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AFTER TIME AFTER TIME AFTER TIME AFTER TIMEACTIVE PHARMACEUTICAL INGREDIENTSNew ProductsAPI Name Therapeutic Usebull Imatinib Mesylate 234 bull anti-neoplastic agent tyrosine kinase inhibitor

bull Mometasone Furoate Monohydrate 12 bull anti-inflammatory

bull Montelukast Sodium 234 bull prophylaxis of asthma

bull Palonosetrone Dihydrochloride 124 bull anti-nauseant anti-emetic agent

bull Rotigotine 124 bull anti Parkinson Dopamine agonist

bull R-Modafinil 23 bull narcolepsy amp idiopathic hypersomnia

1 DMF in preparation 2 GMP material availablel 3 EDMF- APTechnical package available 4 IP package

Products Under DevelopmentAPI Name Therapeutic Usebull Fluticasone Furoate bull anti-inflammatory anti-allergic agent

bull Omeprazole Mg bull proton pump inhibitor

bull Rabeprazole bull proton pump inhibitor

bull Pantoprazole bull proton pump inhibitor

bull Lansoprazole bull proton pump inhibitor

bull Esomeprazole bull proton pump inhibitor

bull Omeprazole bull proton pump inhibitor

bull Dexlansoprazole bull proton pump inhibitor

bull Ambrisentan bull anti hypertensive

bull Fenofibric Acid bull anti-hyperlipoproteinemic

FINAL DOSAGE FORMSChemagis FDFsGeneric Name Therapeutic Usebull Anastrozole 1 mg Tablets bull non-steroidal aromatase inhibitor

bull Granisetron HCl 1 2 mg Tablets bull anti-nauseant anti-emetic agent

bull Granisetron HCl 1 3 mgml Ampoules bull anti-nauseant anti-emetic agent

bull Letrozole 25 mg Tablets bull non-steroidal aromatase inhibitor

bull Moxonidine 02 03 04 mg Tablets bull anti-hypertensive

bull Temozolomide Capsules bull anti-neoplastic alkylating agent

Vertical Integration FDFs (Perrigo)Generic Name Therapeutic Usebull Ammonium Lactate cream lotion bull moisturizer

bull Cetirizine Dihydrochloride syrup bull non-sedative anti-histamine

bull Donepezil 5 10 mg tablets bull anti-Alzheimer cognition enhancer

bull Fluticasone Propionate cream ointment bull anti-inflammatory anti-allergic agent

bull Halobetasol cream ointment bull anti-inflammatory

bull Imiquimod cream bull immune response modifier



Offices

Chemagis Ltd Headquarters31 Lehi St POBox 2231Bnei-Brak 51100IsraelTel 972-3-5773880Fax 972-3-5773868

Chemagis Ltd RampD Center3 Hashlosha St POBox 9091Tel Aviv 61090Israel

Chemagis USA Inc115 Route 46 West Suite D25Mountain LakesNew Jersey 07046 USATel 1-973-402-1355Fax 1-973-402-1388

Plants

Chemagis Ltd POBox 3593 Ramat HovavBeer-Sheva 84135IsraelTel 972-8-6509140Fax 972-8-6572221

Chemagis (Germany) GmbHKasteler Str 45 Building D-546D65203 WiesbadenGermany

Perrigo API (India)Plot N 39N 39-1 MIDC Additional Ambernath Ambernath (East) District Thane MaharashtraIndia

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IndiaProduction

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product approval






IP capabilities


final step




throughput



partnerships















































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IP capabilities


final step




throughput



partnerships















































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Offices




Plants




Mill

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wwwchemagiscom

Chemagis catalog

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Transcript of Chemagis catalog