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For your health

for your health...

Pharmaceutical Manufacturer

Trepham is according EU cGMP guidelines

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“Trepharm” is pharmaceutical manufacturer in Kosovo. Trepharm is built according with full EU cGMP guidelines. Current Good Manufacturing Practice but also other global Quality Standards have been taken in account during design, construction and commissioning of this project, important not only for Kosovo pharma community but for whole nation also.

“Trepharm” from the first moments had the support of well known companies in pharma field that gave us to disposal expertise from their long experience in the area. Besides well known expat experts certi-fied in different fields, Trepharm has a staff of young local professionals who believe that quality is not a privilege of a selected group of people. It can be reached if you are not afraid of the challenge and if you are constantly in search for professional excellence.

“Trepharm” is composed of two production units. Actually the Antibiotic production unit is fully func-tional. Quality is a clear defined objective. It is projected, built and controlled within each process and not only at the end of a process. Quality and safety of “Trepharm” products is controlled in Quality Control Laboratory, built based on GLP standards. This laboratory aims to become a centre that offers analytical services not only to Trepharm but to the whole Kosovo territory.

for your health...

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Vision“Trepharm” becoming a leader in offering pharmaceutical products to the Balkans market, by integrating production and marketing of high quality pharmaceutical products for human and veterinary use.In a near future we aim to make “Trepharm” a leader in pharmaceutical production and trading for Bal-kans market. We focus on patients needs and orient them towards better solutions trough higher quality products with favorable prices. We promote trust! Each section of this enterprise works in function of achieving excellence in order to earn clients trust, trust of our partners and of the community in general.

Mission“For Your Health” is our mission offering products with high European quality in reasonable prices through qualified personnel and advanced technology.Our basic task is to enable people to lead a healthy, good quality life. Trepharm strategy is to produce medicinal products meeting every requirement of quality, efficacy and safety. We use the latest meth-ods and good manufacturing production practice, which has been supplemented and improved over the years.

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for your health...

IntroductionTREPHARM is a manufacturer located in Kosovo - Europe, designed and built according to EU-cGMP standard.

Unit 1. with surface of 2200 m2, from which 800 m2 are production areas for tablets, capsules, dry syrups and powders for oral suspensions.

Unit 2. with surface of 5650 m2 where 2700 m2 are destined for production of solid and liquid, sterile and non- sterile formulations.

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Quality management system of TREPHARM ensures highest levels of quality, with the purpose of producing medicinal products which fulfills EUcGMP requirements and other quality standards for safety, efficacy and quality. Above mentioned objectives are strived through development and up-dated of the following documentation: Quality Risk Management methods are used in order to iden-tify eventual risks of non-conformities related to products and processes, with the scope of defining actions for minimizing of the risks to the acceptable levels. Annual Quality Plan, which regulates key performance issues indicated to be achieved annually, with continues improvement. Standard Opera-tive Procedures (SOP) which manage departments activities within the system.

PersonelTrepharm is managed by pharmaceutical professionals whom are trained in continuation by interna-tional pharma experts, on EU cGMP basis.

Responsibilities- all departments and offices function closely together with each other with the pur-pose of achieving quality products.

for your health...

Qualified person QP is responsi-ble to ensure that each batch of medicinal product is produced and controlled according the current laws ,EUcGMP and by verify the relevant documentation based on Marketing Authorization MA, and signs the form for batch released for sale and distribution. Quality Assurance QA is in charge of the following activities: To monitor and ensure implementation and con-formity with EUcGMP standardAuthorization and implementation of SOPs and other quality docu-mentation Authorization of any deviations, non conformity and out of specification

Authorization of all change controls in process, documentations and materialsMonitor and evaluate stabilities studiesPlanning, defining and implementation of the validation programDefining, monitor and evaluate training programPlanning and implementation of Self-inspection programAuthorization of Suppliers by evaluation of their performance assessment Evaluation and investigation of customer complaintsAuthorize for product recall (if any)Managing environment monitoring programs

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Quality control QC is in charge of the following activities:Sample , analyze, approve and reject raw material/packing materialIssuing of the certificate of analysis for Raw materials and finished productsAnalyze and report about the quality of intermediate and finished productSample, analyze and report about results of the stability of the productPrepare and approve all specification for Raw/Packing material and finished productTo evaluate and ensure that all required test are done and are conform to the specifi-cationManaging maintenance and instrument calibration and validation activities

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For your healthfor your health...

CARDIOVASCULAR

TrePharm Products

Enalarpil HEnalapril Maleate + HydrochlorothiazideTablet 10 +25mg

EnalarpilEnalapril Maleate Tablet 10mg

LocardLosartan Potassium Tablet 50mg

Locard HLosartan Potassium + HydroclorthiazideTablet 50 + 12.5mg

Astat Atorvastatin calcium Tablet 10mg & 20mg

ProcardCarvedilolTablet25mg & 12.5 mg &6.25mg

LisocardLisinopril dihydrateTablet10mg & 20mg

Lisocard HLisinopril dihydrate + HidrochlorthiazidTablet10 & 12.5mg & 20 & 25mg

HCTZHydrochlorthiazideTablet25mg & 50mg

AmlodipineAmlodipine besylate Tablet5mg & 10mg

aspirinPROAcid AcetylsalicylicGastro - resistant tablets75mg & 100mg

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ANTIDIABETICS

ProtopenProton-pump inhibitor.Gastro resistant tablet20mg & 40mg

XalamAlprazolamTablet0.25mg & 0.50mg

Treagra Sildenafil citrateFilm coated tablet50mg & 100mg

ANTACIDS

ANXIOLYTIC

ERECTILE DYSFUNCTION

PrimetMetformin hydrochloride Tablet850mg & 1000mg

GlimurGlimepiride Tablet2mg & 3mg

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For your healthfor your health...

ANTIMICROBIALS Cephalosporin

CefCefalexin monohydrateCapsule 250mg & 500mg& Film coated Tablet1gr & Oral suspension 250mg/5ml

TreclorCefaclor monohydrate Capsule250mg & 500mg & Oral suspension250mg/5ml &125mg/5ml

Cefexel Cefixime trihydrate Tablets, 400mg & Oral suspension 100mg/5ml

Ciprot Ciprofloxacine hydrochlorideFilm coated Tablet500mg & 750mg

NifureX NifuroxazideCapsules100mg & 200mg

ANTIMICROBIALS Quinolone

ANTIMICROBIALS Anti infectives

ANTIMICROBIALS | Macrolide

AzitreAzithromycin dihydrateCapsule500mg & 250mg & Oral suspension200mg/5ml

ErytreErythromycine Capsule250mg & 500mg & Oral suspension250mg/5ml

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ANTIMICROBIALS Lincosamide

Treklin Clindamycin Hydrochloride Capsule 300mg

FungizolFluconazole Capsule 150mg

ANTIMICROBIALS Sulfonamide Antimicrobial

BactreSulfamethoxazole, TrimethoprimTablet400mg & 80mg, 800mg & 160mg

Antimicrobials Antifungal

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For your healthfor your health...

DoloFix Range

Dolofix GripParacetamol + Chlorpheniramine maleate + Phenylephrine HCLTablet 325mg+2mg+5mg

Dolofix AbdomenParacetamol + Dicyclomine HCL + SimethiconeTablet500mg+20mg+10mg

Dolofix ExtraParacetamol + CaffeineTablet500 + 65mg

Dolofix MenstrualParecatamol + IbuprofenTablet 400 + 325mg

Dolofix MuscularParacetamol +ChlorzoxazoneTablet325mg+300mg

DoloHotParacetamol + Chlorpheniramine maleate + Phenylephrine HCLPowder for oral suspension500mg+2mg+5mg

DolofixParacetamol Tablet 500mg

Dolofix ForteParacetamol Tablet 750mg

DoloHot Plus Vitamin CParacetamol + Chlorpheniramine maleate + Phenylephrine HCLEffervescent granules for oral suspension500mg+200mg+ 2mg+5mg

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OTC Range

Vitamin C Ascorbic AcidTablet 50mg

Bisacodyl Bisacodyl Gastro - resistant tablet 5 mg

ACT Acetylcysteine Powder for oral suspension 600mg & Oral suspen-sion 200mg/5ml & 100mg/5ml & Capsule 200mg

Vitamin C Ascorbic AcidTablet 500mg

AlbaDolIbuprofen Film coated Tablet 400mg

AlbaDol PlusIbuprofen + Paracetamol Film coated Tablet400mg+325mg

Loperamide LoperamideTablet 2mg

Albendazole AlbendazoleTablet 200mg & 400mg

Paracetamol ParacetamolTablet 500mg

GENERIKA Range

Republic of Kosovo, EuropeTel: +381 (0) 38 549 222

Web: www.trepharm.com

Middle EastTel: +971 6 573 50 70Fax:+971 6 573 50 71

sawarimd@emirates.net.aeP.O.Box: 38628 SHJ – UAE

King AbdulAziz St.Tower 400-Showroom 1 & 2

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